Breast Cancer Clinical Trials Intelligence
Monthly Update Report - October 2025
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Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.
1: Summary data from new trials identified for Breast Cancer.
Overview
Number of Trials: 32
These 32 trials focus on breast cancer and other solid tumors, spanning early-stage to metastatic disease. Many trials test novel antibody-drug conjugates, CAR-T therapies, and targeted agents for HER2-positive, HER2-low, triple-negative, and hormone receptor-positive breast cancers. Several trials explore supportive care interventions, including palliative care, symptom management, and prevention of treatment-related toxicities. Trials also investigate biomarker-driven therapies, genomic profiling, and innovative imaging or device-based interventions. A subset addresses health disparities, screening optimization, and quality-of-life improvements.
Common Criteria Across Trials
Common Inclusion
- Age ≥18 years
- Histologically or cytologically confirmed breast cancer
- Measurable disease per RECIST v1.1
- ECOG performance status 0-2
- Adequate organ function (liver, kidney, bone marrow)
- Ability to provide informed consent
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception
Common Exclusion
- Pregnant or breastfeeding
- Active or uncontrolled brain metastases
- History of other active malignancies within 2-5 years
- Uncontrolled intercurrent illness or infection
- Prior hypersensitivity to study agents
- Immunodeficiency or active HIV, hepatitis B, or hepatitis C
- Recent major surgery or radiation therapy
- Psychiatric or substance abuse disorders limiting compliance
Outcomes Summary
Primary Outcomes
- Progression-free survival (8 trials)
- Pathologic complete response (4 trials)
- Safety and tolerability (10 trials)
- Overall response rate (5 trials)
- Quality of life or symptom improvement (6 trials)
Secondary Outcomes
- Overall survival (7 trials)
- Pharmacokinetics (6 trials)
- Biomarker analysis (9 trials)
- Adverse events and toxicity (12 trials)
- Patient-reported outcomes (5 trials)
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT06224673 — HER2-low status (IHC 1+ or 2+ without gene amplification)
- NCT06949410 — HER2 positive breast cancer
- NCT07213791 — FAP expression per local assessment
- NCT07174336 — PIK3CA mutation detected in tumor or blood
- NCT06956690 — HER3+ expression by IHC (H-Score ≥50)
Unique or Unusual Criteria
- NCT07218250 — Requires waitlist of ≥2 weeks for counseling center intake
- NCT07220967 — Excludes patients with hypercalcemia or severe degenerative bone disease
- NCT07137871 — Excludes patients with household income outside median Appalachian range once enrollment cap reached
- NCT06960720 — Requires representation of both higher and lower socioeconomic groups
- NCT06731894 — Excludes patients with allergy or aversion to strawberry flavoring
Trials with Emerging Treatments
- NCT06224673 — Phase II Study of ARX788 for HER2-low Breast Cancer
Items: ARX788 (Anvatabart Opadotin)
Note: Anti-HER2 antibody-drug conjugate with auristatin payload for HER2-low tumors - NCT07182149 — Phase 1a/1b Study of NRM-823 in Refractory Solid Tumors
Items: NRM-823
Note: T-cell engager targeting novel tumor-specific antigen - NCT07173751 — Phase III Trial of BNT327 in TNBC Ineligible for PD(L)1 Therapy
Items: Pumitamig (BNT327)
Note: Bispecific antibody targeting PD-L1 and VEGF-A - NCT06956690 — Phase 1/2 Study of HMBD-501 in HER3-Expressing Solid Tumors
Items: ENV-501
Note: HER3-targeted antibody-drug conjugate with exatecan payload - NCT07218003 — Phase 1/1b Study of RNDO-564 in Nectin-4 Expressing Tumors
Items: RNDO-564
Note: Bispecific antibody targeting Nectin-4 and CD28 - NCT07100106 — Phase Ib/II Study of GDC-4198 in ER+, HER2- Breast Cancer
Items: GDC-4198, Giredestrant
Note: Novel CDK4/6 inhibitor and oral selective estrogen receptor degrader - NCT07213791 — Phase 1a/1b Study of LY4337713 in FAP-Positive Solid Tumors
Items: LY4337713
Note: Radioligand therapy targeting fibroblast activation protein - NCT07174336 — Phase 3 Study of LY4064809 in HR+, HER2- Breast Cancer with PIK3CA Mutation
Items: LY4064809 (STX-478)
Note: Next-generation PI3Kα inhibitor for PIK3CA-mutant breast cancer - NCT04119024 — Phase I Study of IL13Ra2 CAR T Cells in Metastatic Melanoma and Solid Tumors
Items: IL13Ralpha2-specific CAR T cells
Note: Hinge-optimized 4-1BB CAR T-cell therapy targeting IL13Ra2 - NCT07085767 — Phase 3 Study of Palazestrant in ER+, HER2- Advanced Breast Cancer
Items: Palazestrant (OP-1250)
Note: Oral complete estrogen receptor antagonist and degrader - NCT07121244 — Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Advanced Breast Cancer
Items: 177Lu-R11228, 68Ga-R11228
Note: Radiopharmaceutical targeting hormone receptor-positive breast cancer - NCT07218432 — Window of Opportunity Study of TheraBionic P1 Device
Items: TheraBionic P1 Device
Note: Amplitude-modulated radiofrequency electromagnetic field device
3: Individual Trial Overviews
NCT07218250
Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Breast Cancer Patients
Organization/Sponsor: Memorial Sloan Kettering Cancer Center
Example patient: A 52-year-old English-speaking woman from New Jersey with advanced breast cancer experiencing psychosocial distress, waiting three weeks for counseling intake, without suicidal ideation or cognitive impairment.
Phase N/A
NCT07218250
Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Breast Cancer Patients
Organization/Sponsor: Memorial Sloan Kettering Cancer Center
Example patient: A 52-year-old English-speaking woman from New Jersey with advanced breast cancer experiencing psychosocial distress, waiting three weeks for counseling intake, without suicidal ideation or cognitive impairment.
Phase N/A
Interventions
-
Behavioral: American Cancer Society booklet
Summary: Educational booklet providing breast cancer awareness, resources, and support information emphasizing early detection and screening for women at risk or with breast cancer (Web Search). -
Behavioral: Single Counseling Session
Summary: One-time counseling using cognitive-behavioral techniques to reduce fear of recurrence, psychosocial distress, and anxiety while improving quality of life in breast cancer patients (Web Search).
Key Inclusion
- Pathologically confirmed breast cancer
- Localized or advanced cancer
- On waitlist 2+ weeks for MSK Counseling Center intake
- Female, age 18 or older
- English fluency
- Lives in New York, New Jersey, or Connecticut
- No active or passive suicidal ideation
- Agrees to audio recording
Key Exclusion
- Current active or passive suicidal ideation
- Significant psychiatric disturbance precluding assessment completion
- Cognitive impairment disorder (delirium or dementia)
- Will complete Counseling Center intake prior to intervention
NCT07220967
A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections Genomic-based
Organization/Sponsor: Memorial Sloan Kettering Cancer Center
Example patient: A 52-year-old English-speaking woman with newly diagnosed breast cancer, BMI 28, non-smoker, scheduled for bilateral mastectomy with immediate prepectoral tissue expander reconstruction at Memorial Sloan Kettering.
Phase N/A
NCT07220967
A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections Genomic-based
Organization/Sponsor: Memorial Sloan Kettering Cancer Center
Example patient: A 52-year-old English-speaking woman with newly diagnosed breast cancer, BMI 28, non-smoker, scheduled for bilateral mastectomy with immediate prepectoral tissue expander reconstruction at Memorial Sloan Kettering.
Phase N/A
Interventions
-
Device: Stimulan Rapid Cure
Summary: Antibiotic-impregnated calcium sulfate device that delivers antibiotics locally to prevent infections after breast tissue expander placement in post-mastectomy breast cancer patients (Summary of Web Search). -
Drug: Vancomycin and Gentamicin
Summary: Vancomycin targets bacterial cell walls and Gentamicin targets bacterial ribosomes; used in trials to prevent infections post-breast surgery (Summary of Web Search). -
Device: Tissue Expander (TE)
Summary: Device used in breast reconstruction that gradually stretches skin and tissue by periodic saline filling to accommodate a permanent implant in a two-stage process (Summary of Web Search).
Key Inclusion
- Female sex
- Aged 18 to 75 years
- Diagnosis of breast cancer or genetic predisposition to breast cancer
- Planned unilateral or bilateral immediate breast reconstruction with prepectoral TE placement
- English speaking
- BMI less than 40 kg/m2
- Not actively smoking or using nicotine products within 6 weeks of surgery
- No history of radiation to the breast
Key Exclusion
- Actively smoking or using nicotine products within 6 weeks of surgery
- Actively using steroids and/or immunosuppressant medication
- History of radiation to the breast
- Contraindications to Stimulan antibiotic bead placement
- Hypercalcemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease
- Known allergy to calcium sulfate, vancomycin, or gentamicin
- Impaired decision-making capacity
- BMI 40 kg/m2 or greater
NCT06224673
Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer Genomic-based
Organization/Sponsor: University of California, San Francisco
Example patient: A 52-year-old woman with HR-positive, HER2-low (IHC 2+, FISH negative) metastatic breast cancer with liver and bone metastases, ECOG 1, who progressed after two prior chemotherapy lines and has adequate cardiac and organ function.
Phase II
NCT06224673
Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer Genomic-based
Organization/Sponsor: University of California, San Francisco
Example patient: A 52-year-old woman with HR-positive, HER2-low (IHC 2+, FISH negative) metastatic breast cancer with liver and bone metastases, ECOG 1, who progressed after two prior chemotherapy lines and has adequate cardiac and organ function.
Phase II
Interventions
-
Drug: ARX788
Summary: ARX788 is an antibody-drug conjugate targeting HER2 that combines an anti-HER2 monoclonal antibody with a potent tubulin inhibitor (MMAF). It is designed for HER2-low breast cancer and shows efficacy in HER2-resistant cases after trastuzumab-based regimens. Source: Summary of Web Search. -
Drug: Amiloride
Summary: Amiloride is a potassium-sparing diuretic with potential anticancer effects targeting sodium channels and showing cytotoxicity in preclinical breast cancer studies. FDA-approved for hypertension and heart failure, used here as topical eye drops for ocular protection. Source: Summary of Web Search. -
Procedure: Biospecimen Collection
Summary: Biospecimen collection involves obtaining tissue or fluid samples for cancer research to study genetic features and disease patterns. Used for testing, diagnostic, and research purposes. Source: NCI Thesaurus and Summary of Web Search. -
Procedure: Computed Tomography (CT)
Summary: Computed Tomography uses X-rays to create cross-sectional images of internal structures to detect breast cancer spread and evaluate treatment response in clinical trials. Source: Summary of Web Search.
Key Inclusion
- HER2-low locally advanced unresectable or metastatic breast cancer (IHC 1+ or 2+ without HER2 gene amplification)
- At least one prior line of chemotherapy or ADC therapy for locally advanced unresectable or metastatic disease
- ECOG performance status 0-2
- At least one measurable lesion per RECIST v1.1
- Left ventricular ejection fraction ≥50% or institutional lower limit of normal
- Adequate organ function (hemoglobin ≥8.0 g/dL, ANC ≥1.0x10^9/L, platelets ≥100,000x10^9/L)
- Stable and treated brain metastases allowed with specific criteria
- Age 18 years or greater with life expectancy of at least 6 months
Key Exclusion
- Prior treatment with ARX-788 or auristatin analogues
- History of interstitial lung disease, pneumonitis, or clinically significant lung disease
- Clinically-significant ocular findings including keratitis, keratopathy, or active eye disease
- History of congestive heart failure, myocardial infarction within 6 months, or QTcF prolongation >470 msec (females) or >450 msec (males)
- Diagnosis of leptomeningeal carcinomatosis
- Significant pulmonary conditions including drug-induced pneumonitis or requirement for supplemental oxygen
- Active systemic or psychiatric illness impacting ability to receive study therapy
- Pregnancy or breastfeeding
NCT06974604
Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087) Genomic-based
Organization/Sponsor: Brown University
Example patient: A 52-year-old woman with triple negative metastatic breast cancer who progressed after first-line chemotherapy, has ECOG status 1, LVEF 55%, no oral pain, and adequate organ function.
Phase 2
NCT06974604
Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087) Genomic-based
Organization/Sponsor: Brown University
Example patient: A 52-year-old woman with triple negative metastatic breast cancer who progressed after first-line chemotherapy, has ECOG status 1, LVEF 55%, no oral pain, and adequate organ function.
Phase 2
Interventions
-
Drug: Datopotamab deruxtecan
Summary: TROP-2 directed antibody-drug conjugate used for treatment of advanced metastatic cancer including HER2-negative breast cancer and non-squamous NSCLC; mechanism involves targeted delivery of cytotoxic payload to TROP-2 expressing tumor cells. -
Drug: Dexamethasone mouthwash
Summary: Corticosteroid mouthwash used prophylactically to prevent stomatitis associated with Datopotamab deruxtecan therapy; mechanism involves local anti-inflammatory action in oral mucosa.
Key Inclusion
- Advanced/metastatic non-squamous NSCLC progressed on at least one prior therapy
- Triple negative breast cancer progressed on at least 1 prior line of therapy
- Hormone receptor positive breast cancer progressed on hormonal therapy including CDK4/6 inhibitor and 1 prior chemotherapy line
- Age ≥18 years
- ECOG performance status 0-2
- LVEF ≥50% by ECHO or MUGA
- Measurable disease by RECIST 1.1
- Baseline oral pain VAS score 0 and normalcy diet scale ≥60
Key Exclusion
- History of non-infectious ILD/pneumonitis or current ILD/pneumonitis
- Clinically significant corneal disease
- Severe hypersensitivity to monoclonal antibodies or polysorbate 80
- Uncontrolled cardiac disease including MI or unstable angina within 6 months
- NYHA Class II-IV heart failure
- Pregnant or lactating
- Active second malignancy
- Uncontrolled infection requiring IV antibiotics
NCT07040891
A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials
Organization/Sponsor: University of Pennsylvania
Example patient: A 52-year-old woman with newly diagnosed breast cancer presenting to Abramson Cancer Center for treatment evaluation who has not yet enrolled in any clinical trial.
Phase N/A
NCT07040891
A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials
Organization/Sponsor: University of Pennsylvania
Example patient: A 52-year-old woman with newly diagnosed breast cancer presenting to Abramson Cancer Center for treatment evaluation who has not yet enrolled in any clinical trial.
Phase N/A
Interventions
-
Behavioral: Just ASK training
Summary: Web-based training program designed to enhance oncology teams' communication skills and understanding of patient needs to improve discussions about breast cancer clinical trials and patient-provider interactions (Source: Web Search).
Key Inclusion
- Oncology team members (physicians, nurses, coordinators) offering breast cancer clinical trials
- Age >18 years
- New or relapsed breast cancer diagnosis
- Evaluated at Abramson Cancer Center
- Able to provide informed consent
Key Exclusion
- Previously completed Just ASK training (for oncology team members)
- Already consented to participate in a breast cancer clinical trial for treatment (for patients)
NCT06949410
Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant for Locally Advanced HER2 Positive Breast Cancer Genomic-based
Organization/Sponsor: Indiana University
Example patient: A 52-year-old woman with HER2-positive, stage III breast cancer who completed neoadjuvant trastuzumab and chemotherapy 4 months ago with residual axillary node involvement, ECOG 1, and normal cardiac function.
Phase 1
NCT06949410
Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant for Locally Advanced HER2 Positive Breast Cancer Genomic-based
Organization/Sponsor: Indiana University
Example patient: A 52-year-old woman with HER2-positive, stage III breast cancer who completed neoadjuvant trastuzumab and chemotherapy 4 months ago with residual axillary node involvement, ECOG 1, and normal cardiac function.
Phase 1
Interventions
-
Biological: HER2 Vaccine
Summary: HER2 vaccine targets HER2 protein overexpressed in breast cancers, stimulating immune response against HER2-positive cells; emulsified in ISA 720 adjuvant (Source: Web Search).
Key Inclusion
- ≥18 years old
- Histologically confirmed HER2 positive breast cancer (HER2 3+ by IHC or 2+ with FISH ratio >2.0)
- High-risk disease: residual invasive carcinoma after neoadjuvant therapy, inflammatory phenotype, clinical stage III, or locally recurrent disease
- Received at least 6 months of HER2 targeted therapy with trastuzumab +/- pertuzumab, TDM-1, or others
- Completed last HER2 therapy within 6 months prior to registration
- ECOG performance status 0-2
- Adequate organ function and LVEF above institutional lower limit
- Negative pregnancy test for women of childbearing potential
Key Exclusion
- Any distant disease recurrence
- Active malignancy other than breast cancer
- Receiving or planned adjuvant CDK4/6 inhibitor therapy
- Positive immediate hypersensitivity skin test to vaccine peptides
- Require corticosteroids or immunosuppressives
- Active autoimmune diseases requiring treatment
- HIV, HBV, or HCV seropositive or active infection
- History of splenectomy, pregnant or breastfeeding
NCT07137871
Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)
Organization/Sponsor: The University of Texas Health Science Center at San Antonio
Example patient: A 52-year-old postmenopausal woman with ER-positive, HER2-negative metastatic breast cancer and measurable lung metastases, ECOG 1, who progressed after 8 months on ribociclib plus letrozole.
Phase 1
NCT07137871
Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)
Organization/Sponsor: The University of Texas Health Science Center at San Antonio
Example patient: A 52-year-old postmenopausal woman with ER-positive, HER2-negative metastatic breast cancer and measurable lung metastases, ECOG 1, who progressed after 8 months on ribociclib plus letrozole.
Phase 1
Interventions
-
Drug: Avasopasem
Summary: Avasopasem is a superoxide dismutase mimetic that catalyzes conversion of superoxide anion to oxygen and hydrogen peroxide, reducing oxidative stress and inflammation in irradiated tissues. FDA-approved for severe oral mucositis in head and neck cancer radiotherapy; being studied here for metastatic breast cancer. Sources: NCI Thesaurus, Web Search.
Key Inclusion
- HR+, HER2 negative metastatic breast cancer
- Progression on CDK 4/6 inhibitor (ribociclib or abemaciclib) and hormonal therapy in metastatic setting
- ER and/or PR expression at least 10% by immunohistochemistry
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Age ≥18 years
- Adequate organ and bone marrow function
- Men and pre/perimenopausal women on ovarian suppression with LHRH agonist
Key Exclusion
- Any systemic therapy in metastatic setting except hormonal therapy with CDK 4/6 inhibitor
- Patients on palbociclib or tamoxifen
- Untreated new or progressive brain metastases or leptomeningeal disease
- Use of concomitant nitrates and PDE5 inhibitors
- Use of potent CYP3A4 inhibitors or inducers unable to discontinue two weeks prior
- Currently pregnant or breastfeeding
- History of another invasive malignancy within 2 years
- Patients previously on palbociclib must have been stable on ribociclib or abemaciclib for at least three months
NCT07182149
A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
Organization/Sponsor: Normunity AccelCo, Inc.
Example patient: A 58-year-old woman with metastatic triple-negative breast cancer refractory to standard therapies, ECOG status 1, with adequate organ function and no recent systemic treatment or history of severe pneumonitis.
Phase 1
NCT07182149
A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
Organization/Sponsor: Normunity AccelCo, Inc.
Example patient: A 58-year-old woman with metastatic triple-negative breast cancer refractory to standard therapies, ECOG status 1, with adequate organ function and no recent systemic treatment or history of severe pneumonitis.
Phase 1
Interventions
-
Biological: NRM-823
Summary: T-cell engager targeting a novel tumor-specific antigen in solid tumors including breast cancer, being tested for safety and efficacy in Phase 1 trial (Source: Web Search).
Key Inclusion
- Histologically or cytologically diagnosed NSCLC, TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer
- Advanced or metastatic disease
- ECOG Performance Status 0 or 1
- Adequate liver, renal, pulmonary, and cardiac function
- Adequate hematologic function
Key Exclusion
- Cytotoxic chemotherapy, biologic agents, checkpoint inhibitors, or radiation therapy within 3 weeks or 5 half-lives prior to first dose
- History of Grade 2 pneumonitis requiring steroids or any Grade 3-4 pneumonitis from prior therapy
- Investigational therapy within 4 weeks or 5 half-lives prior to first dose
- Unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia and Grade ≤2 neuropathy
NCT05874297
Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
Organization/Sponsor: Fred Hutchinson Cancer Center
Example patient: A 52-year-old English-speaking woman with Stage II breast cancer starting ddAC-T chemotherapy at Fred Hutch South Lake Union, not pregnant, with smartphone access and willing to complete online symptom questionnaires throughout treatment.
Phase N/A
NCT05874297
Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy
Organization/Sponsor: Fred Hutchinson Cancer Center
Example patient: A 52-year-old English-speaking woman with Stage II breast cancer starting ddAC-T chemotherapy at Fred Hutch South Lake Union, not pregnant, with smartphone access and willing to complete online symptom questionnaires throughout treatment.
Phase N/A
Interventions
-
Behavioral: Questionnaire Administration
Summary: Assessment tool for patient-reported outcomes and symptoms; evaluates treatment effectiveness in breast cancer research (NCI Thesaurus, Web Search). -
Behavioral: Internet-Based Intervention
Summary: Online platform intervention targeting symptom management and behavior modification; shown effective for improving wellbeing in cancer patients (NCI Thesaurus, Web Search). -
Other: Best Practice
Summary: Standard breast cancer treatment including chemotherapy, endocrine therapy, and targeted therapies; personalized based on molecular profiling (NCI Thesaurus, Web Search).
Key Inclusion
- 18 years of age or older
- Stage I-III breast cancer
- Scheduled to receive ddAC-T, TCHP, or TCPembro-AC chemotherapy at Fred Hutch South Lake Union
- Ability to speak and read English
- Access to smartphone, tablet, or computer and Internet
- Willing to complete online questionnaires and telephone assessments through end of chemotherapy
Key Exclusion
- Pregnant at time of enrollment
- Plan to become pregnant during chemotherapy treatment
NCT07173101
A Phase II, Double-blind, Randomized, Cross-over Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
Organization/Sponsor: University of Utah
Example patient: A 52-year-old English-speaking woman with stage II breast cancer who completed her last chemotherapy cycle 60 days ago and reports significant memory problems and difficulty concentrating affecting daily activities.
Phase 2
NCT07173101
A Phase II, Double-blind, Randomized, Cross-over Clinical Investigation of the Effects of Semiconductor Embedded Therapeutic Garments on Cancer-related Cognitive Impairment in Breast and Gynecological Cancer Patients
Organization/Sponsor: University of Utah
Example patient: A 52-year-old English-speaking woman with stage II breast cancer who completed her last chemotherapy cycle 60 days ago and reports significant memory problems and difficulty concentrating affecting daily activities.
Phase 2
Interventions
-
Device: Sham Headband
Summary: Placebo headband without active components used as control to compare against active treatment for cancer-related cognitive impairment (source: Web Search). -
Device: Semiconductor embedded headband
Summary: Therapeutic headband using semiconductor technology for electrical neuromodulation to improve cognitive function in cancer patients experiencing chemotherapy-related cognitive impairment (source: Web Search).
Key Inclusion
- Aged 18 years or older
- Diagnosis of breast or gynecologic cancer
- Completed chemotherapy within 90 days
- Perceived cognitive impairment score <63 on FACT-Cog-PCI
- Able to wear device at least 18 hours per day for 6 weeks
- ECOG Performance Status ≤3
- Able to speak and understand English
Key Exclusion
- History of neurodegenerative conditions (MS, dementia, Alzheimer's, Parkinson's)
- CNS diseases (stroke, meningitis, TBI) within 12 months
- Poorly controlled psychological disorders (alcohol dependence, major depression, schizophrenia, bipolar)
- Tobacco or nicotine use within 90 days
- Another malignancy diagnosed ≤12 months before enrollment
- Known brain metastases or cranial epidural disease
- Poorly controlled diabetes
- Active infection requiring systemic therapy
NCT07173751
A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease Genomic-based
Organization/Sponsor: BioNTech SE
Example patient: A 58-year-old woman with metastatic triple-negative breast cancer, PD-L1 negative tumor, ECOG status 1, no prior systemic therapy for advanced disease, with measurable lung metastases.
Phase III
NCT07173751
A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease Genomic-based
Organization/Sponsor: BioNTech SE
Example patient: A 58-year-old woman with metastatic triple-negative breast cancer, PD-L1 negative tumor, ECOG status 1, no prior systemic therapy for advanced disease, with measurable lung metastases.
Phase III
Interventions
-
Biologic: Pumitamig
Summary: Pumitamig is a bispecific antibody targeting PD-L1 and VEGF-A, designed to enhance antitumor immunity while inhibiting angiogenesis, investigated for advanced breast cancer and small cell lung cancer (Summary of Web Search). -
Drug: Carboplatin
Summary: Carboplatin is a platinum-based chemotherapy agent that forms DNA cross-links to inhibit cancer cell replication, used in triple-negative breast cancer with less toxicity than cisplatin (FDA label, NCI Thesaurus, Summary of Web Search). -
Drug: Gemcitabine
Summary: Gemcitabine inhibits DNA synthesis to target cancer cells, showing efficacy in metastatic breast cancer especially in combination regimens (Summary of Web Search). -
Drug: Nab-paclitaxel/Paclitaxel
Summary: Nab-paclitaxel/Paclitaxel inhibits microtubule dynamics to disrupt cell division, delivered via albumin-bound nanoparticles for enhanced intracellular uptake in breast cancer treatment (Summary of Web Search). -
Drug: Eribulin
Summary: Eribulin inhibits microtubule dynamics to disrupt cell division, used in advanced breast cancer after prior therapies with demonstrated survival benefit (Summary of Web Search). -
Other: Matching placebo
Summary: A matching placebo mimics the active drug's appearance and administration to distinguish true drug effects from placebo effects in clinical trials (Summary of Web Search).
Key Inclusion
- Ineligible for combination PD(L)1 immunotherapy plus chemotherapy based on tumor PD-L1 expression
- Confirmed locally recurrent inoperable or metastatic TNBC or ER-low HER2-negative breast cancer
- ER and/or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative
- At least one measurable lesion per RECIST v1.1
- Tissue sample (archival or fresh) provided during screening
- ECOG performance status 0 or 1
Key Exclusion
- Prior systemic anticancer therapy for advanced disease
- Prior treatment with PD(L)-1/VEGF bispecific antibody
- Systemic corticosteroids >10 mg/day prednisone equivalent within 7 days
- Live attenuated vaccines within 4 weeks
- Broad-spectrum IV antibiotics within 2 weeks
- Pregnant, breastfeeding, or planning pregnancy within 6 months after last dose
- Major organ surgery, significant trauma, or invasive dental procedures within 28 days
- Allogeneic hematopoietic stem cell or organ transplantation
NCT06956690
A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors Genomic-based
Organization/Sponsor: Hummingbird Bioscience
Example patient: A 58-year-old woman with metastatic HER3-positive breast cancer refractory to standard chemotherapy, ECOG performance status 1, body weight 62 kg, with stable treated brain metastases not requiring steroids.
Phase 1, Phase 2
NCT06956690
A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors Genomic-based
Organization/Sponsor: Hummingbird Bioscience
Example patient: A 58-year-old woman with metastatic HER3-positive breast cancer refractory to standard chemotherapy, ECOG performance status 1, body weight 62 kg, with stable treated brain metastases not requiring steroids.
Phase 1, Phase 2
Interventions
-
Drug: ENV-501
Summary: ENV-501 is a HER3-targeted antibody-drug conjugate composed of a humanized monoclonal antibody linked to exatecan, a DNA topoisomerase I inhibitor. It binds HER3 on tumor cells, internalizes, releases exatecan to inhibit DNA replication, causing cell cycle arrest and apoptosis in HER3-overexpressing tumors. Source: NCI Thesaurus and Web Search.
Key Inclusion
- Body weight ≥40 kg
- Histologically or cytologically confirmed advanced-stage or metastatic HER3+ solid tumors
- Relapsed or refractory to or ineligible for standard therapy
- Unresectable or metastatic cutaneous melanoma (HER3+)
- Locally advanced or metastatic mutated EGFR NSCLC (HER3+)
- Unresectable, locally advanced or metastatic breast cancer
- ECOG performance status 0-2
- Willingness to undergo fresh tumor biopsy if HER3+ status not documented
Key Exclusion
- Prior treatment with HER3-targeted ADC or exatecan-conjugated ADC as last line
- Prior topoisomerase I inhibitor as last line of therapy
- History of noninfectious or drug-induced pneumonitis or interstitial lung disease
- Leptomeningeal disease or symptomatic/uncontrolled brain metastasis
- Active infections requiring IV antibiotics within 2 weeks
- Known seropositivity for HIV, HBV, or HCV (except after vaccination or cure)
- Pregnant or positive β-HCG test
- Active second malignancies requiring therapy
NCT06795529
Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
Organization/Sponsor: Massachusetts General Hospital
Example patient: A 52-year-old woman with metastatic breast cancer, ECOG status 1, identified with high EOL Care Index score, independently functioning and receiving oncology care but not yet enrolled in palliative or hospice services.
Phase N/A
NCT06795529
Randomized Trial of a Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
Organization/Sponsor: Massachusetts General Hospital
Example patient: A 52-year-old woman with metastatic breast cancer, ECOG status 1, identified with high EOL Care Index score, independently functioning and receiving oncology care but not yet enrolled in palliative or hospice services.
Phase N/A
Interventions
-
Behavioral: Enhanced Usual Care
Summary: Standard breast cancer treatment including surgery, chemotherapy, radiation, and hormone therapy focused on tumor reduction and symptom management, serving as control arm (Source: Web Search). -
Behavioral: Palliative Care Intervention, TARGET-PC
Summary: Five-session palliative care intervention targeting communication enhancement and end-of-life care quality for patients with poor prognosis metastatic breast cancer and their caregivers (Source: Web Search).
Key Inclusion
- Age 18 years or older
- Diagnosed with metastatic breast cancer
- Epic EOL Care Index of 15 or greater within 8 weeks
- ECOG performance status 2 or better
- Able to complete questionnaires in English or Spanish
Key Exclusion
- Received outpatient palliative care visit within last six months
- Enrolled in hospice services
- Comorbid condition impairing ability to understand study procedures or consent
NCT07218003
An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression Genomic-based
Organization/Sponsor: Rondo Therapeutics
Example patient: A 62-year-old woman with metastatic triple-negative breast cancer progressing after two lines of chemotherapy, with Nectin-4 positive tumor, Grade 1 peripheral neuropathy, and no history of inflammatory skin conditions.
Phase 1, Phase 1b
NCT07218003
An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression Genomic-based
Organization/Sponsor: Rondo Therapeutics
Example patient: A 62-year-old woman with metastatic triple-negative breast cancer progressing after two lines of chemotherapy, with Nectin-4 positive tumor, Grade 1 peripheral neuropathy, and no history of inflammatory skin conditions.
Phase 1, Phase 1b
Interventions
-
Biological: Pembrolizumab
Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor to enhance T-cell immune responses against tumors; FDA-approved for melanoma, NSCLC, HNSCC, urothelial cancer, and other malignancies (FDA label, NCI Thesaurus). -
Biological: RNDO-564
Summary: Novel bispecific antibody targeting Nectin-4 and CD28 to induce tumor killing in Nectin-4 positive tumors including breast and urothelial cancers; under clinical investigation (Web Search).
Key Inclusion
- Histologically documented incurable, locally advanced or metastatic solid tumors
- Progressive disease on standard therapies or standard therapy not tolerated
- Eligible tumor types: RR la/mUC, NSCLC, HNSCC, CC, GC and GEJ, EC, TNBC
- Urothelial cancer with squamous differentiation or mixed cell types eligible
- Up to 2 prior MMAE-containing therapies allowed if peripheral neuropathy Grade 2 or less
- Measurable disease per RECIST v1.1
- Adequate organ function
Key Exclusion
- More than one prior Nectin-4 targeted agent
- Peripheral neuropathy greater than Grade 2
- History of or active inflammatory skin disease requiring biologics or oral steroids
- Active eczema or psoriasis requiring systemic therapy
NCT06525766
Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer Genomic-based
Organization/Sponsor: Mayo Clinic
Example patient: A 52-year-old woman with ER-positive, HER2-negative metastatic breast cancer with measurable lung metastases, ECOG status 1, hormone-refractory disease, adequate organ function, and no prior metastatic chemotherapy.
Phase N/A
NCT06525766
Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer Genomic-based
Organization/Sponsor: Mayo Clinic
Example patient: A 52-year-old woman with ER-positive, HER2-negative metastatic breast cancer with measurable lung metastases, ECOG status 1, hormone-refractory disease, adequate organ function, and no prior metastatic chemotherapy.
Phase N/A
Interventions
-
Drug: Capecitabine
Summary: Capecitabine is a fluoropyrimidine prodrug converted to 5-fluorouracil in tumor cells, inhibiting thymidylate synthase to block DNA synthesis and disrupt cancer cell proliferation; used for metastatic breast cancer treatment (FDA label, NCI Thesaurus). -
Procedure: Computed Tomography
Summary: Computed tomography uses X-rays and computer reconstruction to create cross-sectional body images for monitoring disease progression and treatment response (NCI Thesaurus). -
Procedure: Magnetic Resonance Imaging
Summary: MRI uses radiofrequency waves and magnetic fields to visualize tumors, assess tumor size, monitor treatment effects, and evaluate disease status without radiation (NCI Thesaurus). -
Procedure: Bone Scan
Summary: Bone scan is a nuclear imaging method using radioactive tracer to detect bone metastases and evaluate pathological bone metabolism in cancer patients (NCI Thesaurus). -
Procedure: Biospecimen Collection
Summary: Collection of tissue or fluid samples for research, testing, and studying genetic features and disease patterns in cancer trials (NCI Thesaurus). -
Other: Questionnaire Administration
Summary: Administration of questionnaires to assess patient-reported outcomes, experiences, and symptoms to evaluate treatment effectiveness in clinical trials (NCI Thesaurus).
Key Inclusion
- Age ≥ 18 years
- ER-positive, HER2-negative metastatic breast cancer
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status 0, 1, or 2
- Adequate hematologic function (hemoglobin ≥9.0 g/dL, ANC ≥1500/mm³, platelets ≥100,000/mm³)
- Adequate hepatic function (bilirubin ≤1.5x ULN, ALT/AST ≤3x ULN)
- Creatinine clearance ≥45 ml/min
- Willingness to provide blood specimens for correlative research
Key Exclusion
- Prior chemotherapy or antibody drug conjugate in metastatic setting
- Pregnant or nursing persons
- Major surgery ≤3 weeks or radiation therapy ≤2 weeks prior
- Evidence of visceral crisis or impending cord compression
- Uncontrolled brain metastasis
- Active infection or uncontrolled intercurrent illness
- History of myocardial infarction ≤6 months
- Homozygous or compound heterozygous DPYD variants with complete DPD absence
NCT06867484
Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial) Genomic-based
Organization/Sponsor: Baptist Health South Florida
Example patient: A 52-year-old postmenopausal woman with ER+HER2- ipsilateral breast cancer recurrence (2 cm, node-negative) two years after initial lumpectomy and radiation, Oncotype score 22, ECOG 1, no BRCA mutations.
Phase N/A
NCT06867484
Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial) Genomic-based
Organization/Sponsor: Baptist Health South Florida
Example patient: A 52-year-old postmenopausal woman with ER+HER2- ipsilateral breast cancer recurrence (2 cm, node-negative) two years after initial lumpectomy and radiation, Oncotype score 22, ECOG 1, no BRCA mutations.
Phase N/A
Interventions
-
Radiation: Intensity modulated radiation therapy (IMRT)
Summary: IMRT precisely targets breast cancer tumors while minimizing radiation to healthy tissues by adjusting dose based on tissue thickness, improving outcomes and reducing side effects (Web Search).
Key Inclusion
- ER+HER2- breast cancer
- Age ≥ 40 years
- Oncotype < 26 (postmenopausal) <16 (premenopausal)
- Minimum 18 months from last breast radiotherapy
- Ipsilateral recurrence, unifocal < 3 cm with negative margins, N0
- ECOG ≤ 2
- Planning target volume whole breast ratio < 1/2
- Life expectancy > 12 months
Key Exclusion
- BRCA1/2 mutation or other receptor subtypes
- Males assigned at birth with breast cancer
- Pregnancy or breastfeeding
- Skin involvement
- Distant metastasis
- Triple negative or HER-2 enriched breast cancer
- Other malignancies except skin
- Connective tissue disorder (scleroderma, lupus)
NCT07100106
A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor Genomic-based
Organization/Sponsor: Genentech, Inc.
Example patient: A 58-year-old woman with metastatic ER-positive, HER2-negative breast cancer and ECOG status 1 who progressed on palbociclib plus letrozole as first-line therapy.
Phase 1, Phase 2
NCT07100106
A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor Genomic-based
Organization/Sponsor: Genentech, Inc.
Example patient: A 58-year-old woman with metastatic ER-positive, HER2-negative breast cancer and ECOG status 1 who progressed on palbociclib plus letrozole as first-line therapy.
Phase 1, Phase 2
Interventions
-
Drug: Abemaciclib
Summary: Abemaciclib is an orally available CDK4/6 inhibitor that blocks retinoblastoma protein phosphorylation, arresting cell cycle in G1 phase and suppressing cancer cell growth in HR-positive, HER2-negative breast cancer (FDA label, NCI Thesaurus). -
Drug: Giredestrant
Summary: Giredestrant is an investigational estrogen receptor antagonist that binds to and induces conformational changes in the estrogen receptor, blocking estrogen action in ER-positive breast cancer (Summary of Web Search). -
Drug: GDC-4198
Summary: GDC-4198 is an investigational CDK4/6 inhibitor targeting estrogen receptor-positive, HER2-negative breast cancer, being studied alone and in combination with giredestrant (Summary of Web Search).
Key Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic
- Previously documented ER-positive and HER2-negative tumor per ASCO/CAP or ESMO guidelines
- Disease progression during or after treatment with approved CDK4/6 inhibitor and endocrine therapy in locally advanced or metastatic setting
- Measurable or non-measurable evaluable disease per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Life expectancy at least 6 months
Key Exclusion
- Advanced symptomatic visceral spread at risk of life-threatening complications requiring cytotoxic chemotherapy
- Received more than one line of therapy for locally advanced or metastatic disease
- Received prior chemotherapy for metastatic breast cancer
- Anti-cancer therapies within 28 days or 5 half-lives prior to study drug initiation
- Poor peripheral venous access
- Malabsorption or GI conditions that may interfere with enteral absorption
- History of malignancy within 3 years prior to screening except cancer under investigation
NCT06960720
Lifting More Than Weights: Feasibility of Implementing a Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
Organization/Sponsor: West Virginia University
Example patient: A 52-year-old female two years post-diagnosis with stage II ER-positive breast cancer experiencing moderate fatigue, receiving ongoing care at WVU Cancer Institute with household income below the Appalachian median.
Phase N/A
NCT06960720
Lifting More Than Weights: Feasibility of Implementing a Resistance Exercise Program Across Socioeconomic Groups for Cancer-Related Fatigue Management
Organization/Sponsor: West Virginia University
Example patient: A 52-year-old female two years post-diagnosis with stage II ER-positive breast cancer experiencing moderate fatigue, receiving ongoing care at WVU Cancer Institute with household income below the Appalachian median.
Phase N/A
Interventions
-
Behavioral: Resistance Exercises
Summary: Resistance exercises improve muscle strength and may reduce cancer-related fatigue through enhanced muscle repair and reduced inflammation, supported by clinical trials (Source: Web Search).
Key Inclusion
- Histologically or cytologically confirmed breast cancer, any molecular subtype
- Non-metastatic breast cancer stage 0, I, II, or III
- Between one and three years post-diagnosis
- Receiving treatment from WVU Cancer Institute
- Any severity or report of fatigue
- Pregnant (first or second trimester) or breastfeeding with OB/GYN approval, singleton pregnancy only
Key Exclusion
- Male biological gender
- Uncontrolled intercurrent illness including active infection, unstable angina, cardiac arrhythmia
- Active alcoholism or psychiatric illness limiting compliance
- Pregnancy beyond second trimester at enrollment
- Multiple gestations (twins, triplets, or higher-order pregnancies)
- Household income above or below Appalachian median if SES group enrollment target met
NCT07146568
Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hospital
Organization/Sponsor: Washington University School of Medicine
Example patient: A 62-year-old English-speaking woman with a 25 pack-year smoking history who quit 10 years ago, presenting for routine screening mammography at Christian Hospital without symptoms or prior cancer history.
Phase N/A
NCT07146568
Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hospital
Organization/Sponsor: Washington University School of Medicine
Example patient: A 62-year-old English-speaking woman with a 25 pack-year smoking history who quit 10 years ago, presenting for routine screening mammography at Christian Hospital without symptoms or prior cancer history.
Phase N/A
Interventions
-
Behavioral: Pink and Pearl Campaign
Summary: A public health campaign integrating lung cancer risk assessment into breast cancer screening programs to enhance early detection through media communication including television, radio, newspapers, and pamphlets (NCI Thesaurus, Web Search).
Key Inclusion
- Undergoing screening mammography at Christian Hospital
- Between the ages of 50-80 years
- 20 pack-year smoking history or quit within past 15 years
- Can speak and understand English
- Willing and able to get treatment if lung cancer is found
Key Exclusion
- Diagnosed with serious health problem limiting life expectancy
- Previous history of lung cancer
- Symptoms of lung cancer such as hemoptysis
- Unexplained weight loss of more than 6.8 kg in previous year
NCT07213791
A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT) Genomic-based
Organization/Sponsor: Eli Lilly and Company
Example patient: A 58-year-old woman with HER2-positive metastatic breast cancer, ECOG PS 1, who has progressed on trastuzumab deruxtecan and one other HER2-targeted therapy, with FAP-positive imaging and normal cardiac function.
Phase 1
NCT07213791
A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT) Genomic-based
Organization/Sponsor: Eli Lilly and Company
Example patient: A 58-year-old woman with HER2-positive metastatic breast cancer, ECOG PS 1, who has progressed on trastuzumab deruxtecan and one other HER2-targeted therapy, with FAP-positive imaging and normal cardiac function.
Phase 1
Interventions
-
Drug: LY4337713
Summary: LY4337713 is an investigational radioligand therapy targeting fibroblast activation protein (FAP)-positive solid tumors. It aims to deliver targeted radiation to FAP-expressing cancer cells. Source: Summary of Web Search.
Key Inclusion
- Clinical or imaging evidence of FAP expression
- Histologically or cytologically confirmed solid tumor diagnosis
- Prior treatment requirements vary by tumor type
- ECOG performance status 0 to 1
- Creatinine clearance ≥60 mL/min
- Pancreatic adenocarcinoma with 1-2 prior regimens
- HR-positive HER2-negative breast cancer with ≤5 prior lines including CDK4/6 inhibitor
- HER2-positive breast cancer progressed on ≥2 HER2-targeted therapies including ADC
Key Exclusion
- Active CNS metastases or carcinomatous meningitis
- History of Grade 4 myelosuppression lasting >7 days
- Grade 3 myelosuppression requiring >6 weeks recovery
- Significant cardiovascular disease
- QTcF prolongation >470 msec
- Previous hemi- or total-body radiation
- Previous adoptive T-cell therapy (CAR-T, TCR)
- Unable to tolerate SPECT, PET, CT, or MRI imaging
NCT07066189
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)
Organization/Sponsor: Yale University
Example patient: A 52-year-old sedentary woman with stage III triple negative breast cancer scheduled for neoadjuvant chemo-immunotherapy who consumes minimal fruits and vegetables and has oncologist clearance for exercise.
Phase N/A
NCT07066189
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)
Organization/Sponsor: Yale University
Example patient: A 52-year-old sedentary woman with stage III triple negative breast cancer scheduled for neoadjuvant chemo-immunotherapy who consumes minimal fruits and vegetables and has oncologist clearance for exercise.
Phase N/A
Interventions
-
Behavioral: Exercise and Medical Nutrition
Summary: Exercise and medical nutrition intervention for weight management and improving health outcomes by enhancing metabolic function and cardiovascular health during neoadjuvant treatment (Source: Web Search).
Key Inclusion
- Female aged 18 years or older
- Stage II or III Triple Negative Breast Cancer
- Scheduled to receive neoadjuvant chemo-immunotherapy
- Physically able to walk
- Not exercising (less than 150 min/week)
- Not consuming more than 7 fruits and vegetables/week
- Oncologist clearance to participate
Key Exclusion
- Already started 2nd chemotherapy cycle
- Pregnancy or intention to become pregnant
- Dementia or major psychiatric disease
- Recent stroke, myocardial infarction, or congestive heart failure (past year)
NCT07174336
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2) Genomic-based
Organization/Sponsor: Eli Lilly and Company
Example patient: A 58-year-old postmenopausal woman with newly diagnosed metastatic HR+/HER2- breast cancer harboring a PIK3CA mutation detected by tissue biopsy, with bone and liver metastases, no diabetes, and no prior treatment for advanced disease.
Phase 3
NCT07174336
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2) Genomic-based
Organization/Sponsor: Eli Lilly and Company
Example patient: A 58-year-old postmenopausal woman with newly diagnosed metastatic HR+/HER2- breast cancer harboring a PIK3CA mutation detected by tissue biopsy, with bone and liver metastases, no diabetes, and no prior treatment for advanced disease.
Phase 3
Interventions
-
Drug: LY4064809
Summary: Next-generation PI3Kα inhibitor targeting PIK3CA mutations in breast cancer, designed to block PI3K signaling pathway that drives cancer cell growth and survival (Summary of Web Search). -
Other: Placebo
Summary: Inactive compound identical in appearance to study drug, used to distinguish drug action from suggestive effects in controlled trials (NCI Thesaurus). -
Drug: Ribociclib
Summary: CDK4/6 inhibitor that blocks cyclin-dependent kinases to arrest cell cycle in G1 phase, preventing cancer cell proliferation in HR+/HER2- breast cancer (FDA label, NCI Thesaurus). -
Drug: Palbociclib
Summary: CDK4/6 inhibitor that blocks cell cycle progression, used with hormonal therapies to improve outcomes in advanced breast cancer (Summary of Web Search). -
Drug: Abemaciclib
Summary: Oral CDK4/6 inhibitor that prevents retinoblastoma protein phosphorylation, arresting cell cycle in G1 phase for HR+/HER2- breast cancer treatment (FDA label, NCI Thesaurus). -
Drug: Anastrozole
Summary: Aromatase inhibitor that reduces estrogen production by blocking aromatase enzyme, used in postmenopausal women with hormone-sensitive breast cancer (Summary of Web Search). -
Drug: Letrozole
Summary: Nonsteroidal aromatase inhibitor that blocks estrogen synthesis by inhibiting aromatase enzyme, reducing circulating estrogen levels in postmenopausal women (FDA label, NCI Thesaurus). -
Drug: Exemestane
Summary: Aromatase inhibitor that blocks estrogen production, used in postmenopausal women with HR+ breast cancer, often after tamoxifen therapy (Summary of Web Search). -
Drug: Fulvestrant
Summary: Estrogen receptor antagonist that blocks estrogen receptors, preventing estrogen from stimulating cancer cell growth in HR+ breast cancer (Summary of Web Search).
Key Inclusion
- HR+/HER2- or HER2-low advanced or metastatic breast cancer
- PIK3CA mutation detected in tumor or blood
- 0-2 prior systemic treatments for advanced disease (Part 1) or 0 prior treatments (Part 2)
- Measurable disease or evaluable bone disease
- Pre/perimenopausal patients must use GnRH agonist for ovarian suppression
- Males with ER+ breast cancer must use GnRH agonist
- Part 2 Population 1: endocrine sensitive (de novo or relapsed >12 months after adjuvant therapy)
- Part 2 Population 2: endocrine resistant (relapsed ≤12 months after adjuvant therapy)
Key Exclusion
- Type 1 or Type 2 diabetes with HbA1c ≥8%, FBG ≥140 mg/dL, or requiring insulin
- Inflammatory or metaplastic breast cancer
- Untreated or active CNS metastases or leptomeningeal disease
- Recent antineoplastic therapy within 14 days or 4 half-lives
- Immunodeficiency or chronic systemic steroids >10 mg prednisone equivalent
- Pregnant, breastfeeding, or planning pregnancy within specified timeframes
NCT04119024
Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors Genomic-based
Organization/Sponsor: Stanford University
Example patient: A 52-year-old woman with stage IV melanoma expressing IL13Ralpha2, ECOG 1, who progressed after pembrolizumab and dabrafenib/trametinib for BRAF V600E mutation, with controlled brain metastases and adequate organ function.
Phase 1
NCT04119024
Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors Genomic-based
Organization/Sponsor: Stanford University
Example patient: A 52-year-old woman with stage IV melanoma expressing IL13Ralpha2, ECOG 1, who progressed after pembrolizumab and dabrafenib/trametinib for BRAF V600E mutation, with controlled brain metastases and adequate organ function.
Phase 1
Interventions
-
Biological: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
Summary: Genetically modified autologous T-cells targeting IL13Ralpha2-expressing tumors via a CAR with 4-1BB co-stimulation and CD3-zeta signaling domains; hinge optimization prevents Fc receptor clearance and CD19t enables tracking; induces selective cytolysis of IL13Ra2-overexpressing cancer cells (NCI Thesaurus). -
Drug: Fludarabine Phosphate
Summary: Fluorinated nucleotide analog that inhibits DNA polymerase, ribonucleotide reductase, and DNA primase to interrupt DNA synthesis; used for lymphodepletion conditioning in this trial; FDA-approved for refractory B-cell CLL (FDA label, NCI Thesaurus). -
Drug: Cyclophosphamide
Summary: Alkylating agent converted to active metabolites that bind DNA and inhibit replication; used for lymphodepletion conditioning prior to CAR T-cell infusion; FDA-approved for various malignancies and nephrotic syndrome (FDA label, NCI Thesaurus). -
Diagnostic: Fludeoxyglucose F-18
Summary: Positron-emitting radiopharmaceutical glucose analog that localizes to areas of high metabolic activity; used in PET imaging to assess tumor response; half-life 109.7 minutes (FDA label, NCI Thesaurus). -
Procedure: Positron Emission Tomography
Summary: Imaging technique measuring gamma radiation from positron-electron collisions to reveal metabolic activity in tissue; used to monitor treatment response and disease progression (NCI Thesaurus). -
Procedure: Magnetic Resonance Imaging
Summary: Imaging using radiofrequency waves and magnetic fields to visualize tumors and assess treatment effects; valuable for diagnosing cancer and monitoring disease (NCI Thesaurus). -
Procedure: Computed Tomography
Summary: X-ray imaging method using computer reconstruction to create cross-sectional scans; used to monitor disease progression and treatment response (NCI Thesaurus). -
Procedure: Biospecimen Collection
Summary: Gathering of tissue or fluid samples for testing, research, and diagnostic purposes to study disease patterns and genetic features (NCI Thesaurus). -
Procedure: Biopsy
Summary: Removal of tissue specimens for microscopic examination to establish diagnosis and confirm IL13Ra2 tumor expression (NCI Thesaurus).
Key Inclusion
- Stage IIIC or IV melanoma or metastatic solid tumor refractory to standard therapies
- IL13Ralpha2 tumor expression confirmed by IHC (H-Score ≥50 in ≥10% of tumor)
- Age 18-75 years
- ECOG performance status 0 or 1
- Measurable disease by RECIST or documented skin lesions
- Melanoma patients must have progressed after immune checkpoint inhibitor and BRAF/MEK inhibitor if BRAF V600 mutated
- Adequate organ function (ANC ≥1x10^9/L, platelets ≥75x10^9/L, hemoglobin ≥9.5 g/dL)
- Willing to undergo leukapheresis
Key Exclusion
- Systemic cancer treatment within 14 days of conditioning chemotherapy
- Clinically active brain metastases
- Systemic corticosteroids or immunosuppressive drugs within 2 weeks
- HIV seropositivity or acquired immune deficiency
- Hepatitis B or C with ongoing liver damage
- Left ventricular ejection fraction <45%
- Significant cardiac conduction abnormalities or arrhythmias
- Pregnancy or breastfeeding
NCT06934239
A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Organization/Sponsor: Jonsson Comprehensive Cancer Center
Example patient: A 52-year-old woman undergoing routine screening mammography at UCLA who has not opted out of research participation.
Phase N/A
NCT06934239
A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients
Organization/Sponsor: Jonsson Comprehensive Cancer Center
Example patient: A 52-year-old woman undergoing routine screening mammography at UCLA who has not opted out of research participation.
Phase N/A
Interventions
-
Device: Artificial intelligence (AI) decision-support tool
Summary: An AI decision-support tool that interprets screening mammograms to assist radiologists in identifying potential breast cancer cases and improve detection accuracy (Source: Web Search).
Key Inclusion
- At least 18 years of age or older
- Receive a screening mammogram at participating breast imaging facility
- Radiologist who interprets screening mammograms at participating facility
Key Exclusion
- Patients who have opted out of all research at the health system
NCT06845319
Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients With Cardiomyopathy or at an Elevated Risk of Cardiotoxicity (NeoCARD): A Response Adapted Single-arm Phase 2 Trial Genomic-based
Organization/Sponsor: Medical University of South Carolina
Example patient: A 52-year-old woman with Stage II triple-negative breast cancer, 2.5cm tumor, ER/PR <10%, HER2-negative, with preexisting cardiomyopathy (EF 40%) and no prior cancer treatment, making her ineligible for anthracyclines.
Phase 2
NCT06845319
Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients With Cardiomyopathy or at an Elevated Risk of Cardiotoxicity (NeoCARD): A Response Adapted Single-arm Phase 2 Trial Genomic-based
Organization/Sponsor: Medical University of South Carolina
Example patient: A 52-year-old woman with Stage II triple-negative breast cancer, 2.5cm tumor, ER/PR <10%, HER2-negative, with preexisting cardiomyopathy (EF 40%) and no prior cancer treatment, making her ineligible for anthracyclines.
Phase 2
Interventions
-
Biological: Pembrolizumab
Summary: Humanized monoclonal IgG4 antibody that blocks PD-1 receptors on T-cells, preventing binding of PD-L1/PD-L2 ligands and enhancing immune-mediated tumor destruction. FDA-approved for multiple solid tumors and hematologic malignancies. Sources: FDA label, NCI Thesaurus. -
Drug: Paclitaxel
Summary: Microtubule inhibitor that binds tubulin and prevents microtubule disassembly, disrupting cell division and inducing apoptosis. FDA-approved for ovarian, breast, lung cancers and Kaposi's sarcoma. Sources: FDA label, NCI Thesaurus. -
Drug: Carboplatin
Summary: Second-generation platinum compound that forms reactive complexes causing DNA intrastrand and interstrand cross-links, inducing apoptosis. FDA-approved for advanced ovarian carcinoma. More stable and less toxic than cisplatin. Sources: FDA label, NCI Thesaurus.
Key Inclusion
- Histologically confirmed TNBC Stage II or Stage IIIA/B
- Measurable tumor in breast larger than 1cm
- ER and PR staining <10% of invasive cancer cells
- HER2-negative per ASCO-CAP guidelines
- Ineligible for anthracycline treatment due to cardiomyopathy (EF 25-49%), severe valvular disease, prior anthracyclines, high-dose chest radiation >30Gy, or medium/high CHF risk
- ECOG performance status 0-2
- Adequate organ function including ANC ≥1500/uL, platelets ≥100,000/uL, creatinine ≤1.5 mg/dL
- No previous chemotherapy, immunotherapy, radiation, or surgery for this breast cancer
Key Exclusion
- Metastatic or inflammatory breast cancer
- EF less than 25% at screening
- Uncontrolled hypertension (systolic >180 or diastolic >100 bpm) or symptomatic arrhythmia
- Active autoimmune disease requiring systemic treatment in past year
- History of HIV, active Hepatitis B or C
- Chronic systemic steroid therapy exceeding 10 mg daily prednisone equivalent
- Pregnant or breastfeeding
- Concomitant or previous malignancies within last 5 years (except basal/squamous cell skin cancer or carcinoma in situ)
NCT07219797
Study of Monochromatic X-ray Mammography System
Organization/Sponsor: Imagine Scientific, Inc.
Example patient: A 52-year-old woman with prior routine mammograms, no history of breast cancer or breast surgery, and not pregnant or undergoing active cancer treatment.
Phase N/A
NCT07219797
Study of Monochromatic X-ray Mammography System
Organization/Sponsor: Imagine Scientific, Inc.
Example patient: A 52-year-old woman with prior routine mammograms, no history of breast cancer or breast surgery, and not pregnant or undergoing active cancer treatment.
Phase N/A
Interventions
-
Device: 2-D Monochromatic X-ray Mammography System
Summary: Uses single energy level X-rays to improve breast cancer detection with clearer images and reduced radiation exposure compared to conventional mammography (Web Search).
Key Inclusion
- Female
- 40 years of age or older
- Capable of giving informed consent
- Prior history of mammography
Key Exclusion
- Pregnancy
- History of breast cancer surgery, including lumpectomy or mastectomy
- Currently undergoing treatment for breast cancer
- Previous breast augmentations
NCT07127003
Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema
Organization/Sponsor: University of South Florida
Example patient: A 52-year-old English-speaking woman with newly diagnosed breast cancer and clinically positive axillary lymph nodes requiring unilateral ALND without prior axillary surgery or lymphedema.
Phase N/A
NCT07127003
Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema
Organization/Sponsor: University of South Florida
Example patient: A 52-year-old English-speaking woman with newly diagnosed breast cancer and clinically positive axillary lymph nodes requiring unilateral ALND without prior axillary surgery or lymphedema.
Phase N/A
Interventions
-
Procedure: Immediate Lymphatic Reconstruction
Summary: Surgical reconstruction of lymphatic vessels during axillary lymph node dissection to restore lymphatic flow and prevent lymphedema in breast cancer patients, showing early low lymphedema rates (Web Search).
Key Inclusion
- Unilateral axillary lymph node dissection (ALND)
- Prior sentinel lymph node biopsy allowed if <6 months from consent
- Clinically or radiographically positive lymph node
- At least one transected lymphatic channel and vein identified for bypass
- Female breast cancer patients
- Age 18-75 years
Key Exclusion
- Male breast cancer patients
- Non-English speaking
- Axillary recurrence
- History of prior ALND
- Bilateral ALND required
- Primary or secondary lymphedema of affected limb
- Prior axillary radiotherapy
- Distant metastases at screening
NCT07218432
A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
Organization/Sponsor: Barbara Ann Karmanos Cancer Institute
Example patient: A 55-year-old woman with stage II ER-positive, HER2-negative invasive breast cancer, ECOG status 0, scheduled for upfront surgery in three weeks with no prior neoadjuvant therapy.
Phase N/A
NCT07218432
A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
Organization/Sponsor: Barbara Ann Karmanos Cancer Institute
Example patient: A 55-year-old woman with stage II ER-positive, HER2-negative invasive breast cancer, ECOG status 0, scheduled for upfront surgery in three weeks with no prior neoadjuvant therapy.
Phase N/A
Interventions
-
Device: TheraBionic P1 Device
Summary: Uses amplitude-modulated radiofrequency electromagnetic fields to target breast cancer cells, tested for potential to enhance cancer-specific therapies in hormone receptor-positive breast cancer (Source: Web Search).
Key Inclusion
- Histologically proven invasive breast cancer that is HR positive and HER2 negative
- Early-stage operable disease (stage I-II or III) with planned upfront surgery
- Available for at least two weeks of TheraBionic treatment prior to resection
- Women aged 22 years or older
- ECOG performance status 0-2
- Archival tissue available
Key Exclusion
- Receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy
- Known active secondary malignancy that may interfere with safety and efficacy
- Taking any other investigational drugs
- Pregnant or breastfeeding
- Active oral mucosal inflammation, ulceration, or pathology interfering with device use
- Receiving calcium channel blockers unless discontinued at least one day prior to treatment
NCT07085767
A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02) Genomic-based
Organization/Sponsor: Olema Pharmaceuticals, Inc.
Example patient: A 58-year-old postmenopausal woman with newly diagnosed ER-positive, HER2-negative metastatic breast cancer with bone and liver metastases, ECOG status 1, adequate organ function, and no prior systemic therapy for advanced disease.
Phase 3
NCT07085767
A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02) Genomic-based
Organization/Sponsor: Olema Pharmaceuticals, Inc.
Example patient: A 58-year-old postmenopausal woman with newly diagnosed ER-positive, HER2-negative metastatic breast cancer with bone and liver metastases, ECOG status 1, adequate organ function, and no prior systemic therapy for advanced disease.
Phase 3
Interventions
-
Drug: Palazestrant
Summary: Palazestrant is an experimental oral complete estrogen receptor antagonist and selective estrogen receptor degrader targeting ER+ breast cancer, being tested against standard hormonal therapies for advanced ER+ HER2-negative disease (Summary of Web Search). -
Drug: Palazestrant matching-placebo
Summary: Placebo control for palazestrant used in blinded comparison trial. -
Drug: Letrozole
Summary: Letrozole is a nonsteroidal aromatase inhibitor that reduces estrogen production by inhibiting aromatase enzyme, indicated for hormone receptor-positive breast cancer in postmenopausal women (FDA label, NCI Thesaurus). -
Drug: Letrozole-matching placebo
Summary: Placebo control for letrozole used in blinded comparison trial (Summary of Web Search). -
Drug: Ribociclib
Summary: Ribociclib is an oral CDK4/6 inhibitor that blocks cell cycle progression by inhibiting cyclin-dependent kinases, indicated for hormone receptor-positive HER2-negative breast cancer combined with endocrine therapy (FDA label, NCI Thesaurus).
Key Inclusion
- ER+, HER2- locally advanced or metastatic breast cancer not amenable to curative therapy
- Evaluable disease (measurable per RECIST 1.1 or bone-only disease)
- De novo advanced breast cancer or recurrence >12 months after completing adjuvant endocrine therapy
- ECOG performance status 0 or 1
- Adequate hematologic, hepatic, and renal functions
- Pre-, peri- or postmenopausal female participants
- Male and pre/peri-menopausal females willing to take GnRH agonist
Key Exclusion
- Disease recurrence during adjuvant endocrine therapy
- Previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer
- Previously received fulvestrant, elacestrant or investigational endocrine therapy
- History of allergic reactions to study treatment
- Contraindications to letrozole and ribociclib
- Symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease, or spinal cord compression requiring immediate treatment
NCT07121244
Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer
Organization/Sponsor: Radionetics Oncology
Example patient: A 52-year-old woman with ER-positive, HER2-negative metastatic breast cancer refractory to multiple endocrine therapies and one prior chemotherapy line, ECOG status 1, with stable treated brain metastases.
Phase 1
NCT07121244
Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer
Organization/Sponsor: Radionetics Oncology
Example patient: A 52-year-old woman with ER-positive, HER2-negative metastatic breast cancer refractory to multiple endocrine therapies and one prior chemotherapy line, ECOG status 1, with stable treated brain metastases.
Phase 1
Interventions
-
Radiopharmaceutical: 177Lu-R11228
Summary: A radiopharmaceutical that delivers targeted radiation to hormone receptor-positive breast cancer cells by binding to specific receptors on tumor cells (Summary of Web Search). -
Radiopharmaceutical: 68Ga-R11228
Summary: A diagnostic radiopharmaceutical targeting estrogen receptor-positive breast cancer to detect lesions, potentially used with 177Lu-R11228 for treatment (Summary of Web Search).
Key Inclusion
- ER/PR positive and HER2 negative locoregionally recurrent or metastatic breast cancer
- At least one target or non-target lesion per RECIST v1.1
- Age ≥18 years
- Part B: Refractory to endocrine therapy
- Part B: Received or declined at least one line of chemotherapy or antibody drug conjugate
- Part B: ECOG Performance Status 0 or 1
- Part B: Life expectancy at least six months
- Part B: Adequate bone marrow, hepatic and renal function
Key Exclusion
- Not recovered from clinically significant adverse events from recent anticancer therapy
- Active CNS disease except stable treated brain metastases for ≥1 month without corticosteroids
- Radiotherapy for breast cancer ≤28 days prior
- Received radionuclide within 10 physical half-lives prior to dosing
- Part B: Anticancer therapy or investigational drug within 21 days or 5 half-lives
- Part B: Prior systemic radionuclide therapeutic treatment
- Part B: Unresolved Grade 2 or higher toxicity from previous treatment
- Condition precluding proper imaging procedures
NCT06731894
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
Organization/Sponsor: City of Hope Medical Center
Example patient: A 52-year-old English-speaking woman with ECOG 1 who completed paclitaxel chemotherapy 8 months ago and now has grade 2 peripheral neuropathy with FACT/GOG-Ntx score of 15, not currently on chemotherapy or hormonal therapy.
Phase N/A
NCT06731894
A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
Organization/Sponsor: City of Hope Medical Center
Example patient: A 52-year-old English-speaking woman with ECOG 1 who completed paclitaxel chemotherapy 8 months ago and now has grade 2 peripheral neuropathy with FACT/GOG-Ntx score of 15, not currently on chemotherapy or hormonal therapy.
Phase N/A
Interventions
-
Drug: Dronabinol
Summary: Synthetic delta-9-THC cannabinoid that binds cannabinoid receptors in the CNS to stimulate appetite, reduce nausea, and induce analgesia; FDA-approved for AIDS-related anorexia and chemotherapy-induced nausea (FDA label, NCI Thesaurus). -
Drug: Cannabidiol
Summary: Phytocannabinoid with analgesic and anti-inflammatory properties; activates autophagy, promotes apoptosis via ER stress and AKT/mTOR inhibition; FDA-approved for seizures in Lennox-Gastaut, Dravet, and tuberous sclerosis (FDA label, NCI Thesaurus). -
Other: Placebo Administration
Summary: Medically inactive control intervention used to compare against active treatment and assess efficacy in clinical trials (NCI Thesaurus, Web Search). -
Other: Survey Administration
Summary: Presentation of questionnaires to gather patient-reported outcomes and assess treatment experiences and effects in clinical trials (NCI Thesaurus, Web Search). -
Procedure: Biospecimen Collection
Summary: Gathering of tissue or fluid samples for testing, research, and diagnostic purposes to study disease patterns and genetic features (NCI Thesaurus, Web Search).
Key Inclusion
- Age ≥18 years with ECOG performance status ≤2
- Neuropathy ≥1 by CTCAE v5.0 or neuropathy score >3 on 0-10 scale plus FACT/GOG-Ntx >10
- Previous chemotherapy with taxane or platinum considered primary cause of neuropathy
- Ability to read and understand English for questionnaires
- Willingness to comply with medical cannabis use and follow-up assessments
- Adequate liver function: bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control through 1 month after last dose
Key Exclusion
- Active chemotherapy, radiation, or surgery in past 3 months or planned during study
- Treatment with neuropathic agents including taxane, platinum, vinca alkaloid, or bortezomib within 6 months
- Concurrent use of medical cannabis, herbal agents, or high-dose vitamins/minerals
- History of diabetic neuropathy, HIV-related neuropathy, or other chronic neuropathy causes
- Previous medical cannabis use within 30 days of enrollment
- Liver cirrhosis Child-Pugh B or C
- Strong CYP3A4 inhibitors or inducers
- Pregnant or breastfeeding females
NCT06957535
Community-led Navigation to Address Disparities in Mammography Among Native American Women
Organization/Sponsor: Johns Hopkins Bloomberg School of Public Health
Example patient: A 52-year-old American Indian woman registered at Chinle Comprehensive HealthCare Facility who has not had a mammogram in over a year and lives 50 miles from the facility.
Phase N/A
NCT06957535
Community-led Navigation to Address Disparities in Mammography Among Native American Women
Organization/Sponsor: Johns Hopkins Bloomberg School of Public Health
Example patient: A 52-year-old American Indian woman registered at Chinle Comprehensive HealthCare Facility who has not had a mammogram in over a year and lives 50 miles from the facility.
Phase N/A
Interventions
-
Behavioral: TEAM
Summary: Community-led intervention to improve mammography screening access and uptake among Native American women through structured support and coordination (Summary of Web Search). -
Behavioral: Navigation
Summary: Patient navigation guiding participants through healthcare systems using support and education to reduce care disparities and improve mammography screening outcomes (Summary of Web Search).
Key Inclusion
- Self-identify as American Indian or Alaska Native
- Female
- Age 40-74 years
- Registered patient at Chinle Comprehensive HealthCare Facility
- Live within 80 miles of CCHFC
- No mammogram within prior 12 months
- No personal history of breast cancer
- Willing to be randomized
Key Exclusion
- Not American Indian or Alaska Native
- Not female
- Outside age range 40-74 years
- Not registered at CCHCF
- Live beyond 80 miles of CCHCF
- Mammogram within prior 12 months
- Personal history of breast cancer
- Planning to move within 6 months