Breast Cancer Clinical Trials Intelligence
Monthly Update Report for Trials Started in December 2025
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1: Summary data from new trials identified for Breast Cancer.
Overview
Number of Trials: 29
These 29 trials span diverse breast cancer populations and other solid tumors, testing novel agents, combinations, and supportive interventions. Many focus on HR+/HER2- advanced breast cancer with endocrine resistance, PIK3CA/AKT1/PTEN alterations, or CDK4/6 inhibitor progression. Trials include immunotherapy (pembrolizumab, cemiplimab, nivolumab), targeted therapies (elacestrant, capivasertib, olaparib, ARX788, AMXT 1501), antibody-drug conjugates (sacituzumab govitecan, trastuzumab deruxtecan), radiopharmaceuticals (lutetium Lu 177 dotatate), and supportive care (exercise, nutrition, symptom management). Several trials explore biomarker-driven strategies (ESR1 mutations, BRCA/HRD, PD-L1, SSTR expression). Non-operative management, radioembolization, and precision imaging (FAPI PET) are also evaluated.
Common Criteria Across Trials
Common Inclusion
- Age ≥18 years
- Histologically or cytologically confirmed breast cancer or solid tumor
- Measurable or evaluable disease per RECIST 1.1
- ECOG performance status 0-2
- Adequate organ function (bone marrow, liver, kidney)
- Life expectancy ≥6-12 weeks
- Postmenopausal status or effective contraception for women of childbearing potential
- Prior standard therapy or progression on endocrine therapy
- Ability to provide informed consent and comply with study procedures
Common Exclusion
- Active brain metastases or leptomeningeal disease (unless treated and stable)
- Uncontrolled intercurrent illness or infection
- Pregnancy or breastfeeding
- Active autoimmune disease requiring systemic treatment
- Prior malignancy within 2-5 years (except adequately treated non-melanoma skin cancer or in situ carcinoma)
- Uncontrolled hypertension or cardiac disease
- Recent major surgery or radiation therapy within specified washout periods
- Known hypersensitivity to study drugs
- Concurrent investigational therapy or chemotherapy
Outcomes Summary
Primary Outcomes
- Progression-free survival (8 trials)
- Overall response rate (6 trials)
- Safety and tolerability (adverse events, dose-limiting toxicities) (12 trials)
- Pathologic complete response (2 trials)
- Feasibility (enrollment, adherence, completion rates) (5 trials)
- Quality of life and symptom burden (4 trials)
- Imaging response (RECIST, PET uptake) (3 trials)
Secondary Outcomes
- Overall survival (7 trials)
- Duration of response (5 trials)
- Clinical benefit rate (4 trials)
- Pharmacokinetics and pharmacodynamics (6 trials)
- Biomarker analysis (ctDNA, tumor tissue, immune markers) (9 trials)
- Patient-reported outcomes (pain, fatigue, function) (6 trials)
- Time to progression or treatment failure (4 trials)
- Surgical outcomes (flap perfusion, complications) (1 trials)
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT06963905 — PD-L1 positive (CPS >10) by IHC
- NCT07174336 — ESR1 mutation (E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G) documented
- NCT06224673 — HER2-low (IHC 1+ or 2+ ISH negative)
- NCT07227233 — PIK3CA/AKT1/PTEN alterations; palbociclib-sensitive disease per palbo-VNN model
- NCT06856499 — BRCA mutation (tumor or germline) and/or tumor HRD positive
- NCT07318805 — HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations
- NCT07222215 — PIK3CA/AKT1/PTEN alterations; ESR1-mutated advanced breast cancer
- NCT07288359 — CCNE1 amplification (for dose expansion)
- NCT04529044 — SSTR expression (>50% of lesions with DOTATATE uptake equivalent to liver)
Unique or Unusual Criteria
- NCT07242118 — Age ≥65 years; non-operative management; tumor ≤5 cm
- NCT07032545 — BMI >30 kg/m²; willing to avoid cruciferous vegetables during study
- NCT07277738 — Dense breasts (Class C or D); MRS risk >3% 5-year; no more than 1 prior mammogram
- NCT07285044 — Resides in Florida Panhandle; home Wi-Fi connection; social stability screener
- NCT07224464 — Rib cage circumference ≤90 cm; no electronic or conductive implants
- NCT06802172 — Alaska Native or American Indian; BMI ≥18.5 kg/m²; score <4 on food security survey
- NCT07226102 — Score ≥34 on Fear of Progression Short-Form indicating dysfunctional levels
Trials with Emerging Treatments
- NCT06917313 — Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Items: Fezolinetant
Note: NDA-approved NK3 receptor antagonist for vasomotor symptoms; novel use in breast cancer patients on endocrine therapy - NCT07032545 — Metabotyping of Broccoli Microgreen in Obese Breast Cancer Survivors
Items: Broccoli microgreen (BMG)
Note: Functional food intervention; no FDA approval; studied for cancer prevention via antioxidant/anti-inflammatory mechanisms - NCT06963905 — Sacituzumab Govitecan Plus Nivolumab or Nivolumab and Relatlimab for PD-L1 Positive Metastatic Triple Negative Breast Cancer
Items: Relatlimab FDC + Nivolumab
Note: BLA-approved dual checkpoint inhibitor (PD-1 + LAG-3); novel combination with antibody-drug conjugate in TNBC - NCT06224673 — ARX788 for HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer
Items: ARX788 (Anvatabart Opadotin)
Note: Site-specific antibody-drug conjugate targeting HER2; novel oxime linker and MMAF payload; no FDA approval - NCT07222267 — BG-75202 in Advanced Solid Tumors
Items: BG-75202
Note: KAT6A/B inhibitor; novel epigenetic target; no FDA approval; studied in breast cancer and solid tumors - NCT07224464 — Sarah Nanotechnology System With Alternating Magnetic Field in Advanced Metastatic Solid Tumors
Items: Sarah Nanotechnology System (Hyperthermia)
Note: Nanotechnology-based thermal ablation using alternating magnetic field; no FDA approval; novel mechanism - NCT07311993 — CLR 125 in Relapsed or Refractory Triple Negative Breast Cancer
Items: CLR 125, Iopofosine I 131 (CLR 131)
Note: Radioactive iodine-labeled phospholipid ether analog; targeted radiotherapy; no FDA approval for cancer indication - NCT07227233 — AI and Machine Learning-Enhanced Biomarker-Driven CDK4/6 Inhibitor Rechallenge
Items: Palbo-VNN model (AI/ML biomarker)
Note: Artificial intelligence-driven patient selection for CDK4/6 inhibitor rechallenge; novel precision oncology approach - NCT07174336 — LY4064809 Combined With CDK4/6 Inhibitor and Endocrine Therapy in HR+, HER2- Advanced Breast Cancer With PIK3CA Mutation
Items: LY4064809 (Tersolisib)
Note: Selective PIK3CA H1047X mutant inhibitor; brain-penetrant; no FDA approval; novel allosteric mechanism - NCT07318805 — PF-08032562 in Advanced or Metastatic Solid Tumors
Items: PF-08032562
Note: Investigational agent; mechanism and target not publicly disclosed; no FDA approval - NCT07288359 — GVV858 as Single Agent and in Combination With Endocrine Therapy
Items: GVV858
Note: Investigational agent; mechanism and target not publicly disclosed; no FDA approval - NCT06856499 — Cirtuvivint With Olaparib in BRCA/HRD Platinum Resistant Ovarian Cancer
Items: Cirtuvivint
Note: CDC-like kinase inhibitor; no FDA approval; novel combination with PARP inhibitor - NCT07287917 — AMXT 1501 and DFMO in Combination With Standard of Care in Advanced Solid Tumors
Items: AMXT 1501 Dicaprate, DFMO (Difluoromethylornithine)
Note: Polyamine transport inhibitor (AMXT 1501) combined with ornithine decarboxylase inhibitor (DFMO); novel immunostimulating mechanism
3: Individual Trial Overviews
NCT06917313
A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy Genomic-based
Organization/Sponsor: Yale University
Example patient: A 52-year-old postmenopausal woman with stage II HR-positive breast cancer on adjuvant tamoxifen for 6 months, experiencing 10 moderate to severe hot flashes daily, with BMI 28 and normal liver and kidney function.
Phase 2
NCT06917313
A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy Genomic-based
Organization/Sponsor: Yale University
Example patient: A 52-year-old postmenopausal woman with stage II HR-positive breast cancer on adjuvant tamoxifen for 6 months, experiencing 10 moderate to severe hot flashes daily, with BMI 28 and normal liver and kidney function.
Phase 2
Interventions
-
Drug: Fezolinetant
Summary: An orally bioavailable NK3 receptor antagonist that blocks neurokinin B binding in the CNS thermoregulatory center to treat moderate to severe vasomotor symptoms associated with menopause, offering a non-hormonal treatment option for hot flashes and night sweats (FDA label, NCI Thesaurus). -
Other: Placebo
Summary: An inactive compound identical in appearance to the active drug, administered to distinguish between drug action and suggestive effects in experimental research (NCI Thesaurus).
Key Inclusion
- Women with clinical stage I-III HR+ invasive breast cancer
- Currently on endocrine therapy (tamoxifen or aromatase inhibitors)
- Postmenopausal or chemically suppressed with GnRH agonist
- On endocrine therapy for minimum 3 months with 12 weeks remaining
- Seven or more moderate to severe hot flashes per day
- BMI 18-38 kg/m2
- Age 40-65
Key Exclusion
- Stage IV metastatic disease
- Receiving cancer treatment other than endocrine therapy
- Receiving CYP1A2 inhibitors
- Any vasomotor symptom treatment in last 28 days
- Pregnant or lactating
- Active liver disease or elevated liver enzymes >2x ULN
- Creatinine >1.5x ULN or eGFR ≤30 mL/min
NCT07242118
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Organization/Sponsor: University of Kansas Medical Center
Example patient: A 72-year-old woman with a 3 cm ER-positive, HER2-negative invasive breast carcinoma, clinically node-negative, who declined surgery and is suitable for stereotactic ablative radiotherapy.
Phase N/A
NCT07242118
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Organization/Sponsor: University of Kansas Medical Center
Example patient: A 72-year-old woman with a 3 cm ER-positive, HER2-negative invasive breast carcinoma, clinically node-negative, who declined surgery and is suitable for stereotactic ablative radiotherapy.
Phase N/A
Interventions
-
Radiation: SABR
Summary: Stereotactic ablative body radiotherapy delivers one or several maximum dose radiation treatments targeting cancers of the body, excluding brain or spine, for localized breast cancer treatment (NCI Thesaurus).
Key Inclusion
- Women age 65 years or older
- Invasive breast carcinoma undergoing non-operative management
- Tumor measuring ≤5 cm (cT1-T2) and clinically node negative
- ER-positive (≥10% by immunohistochemistry)
- HER2-negative per ASCO/CAP guidelines
- Previously untreated or treated with endocrine therapy or chemotherapy with stable or progressive localized disease
- Suitable for SABR per radiation oncologist
Key Exclusion
- Active systemic chemotherapy for breast cancer
- Multicentric tumor
- Clinical or imaging evidence of distant metastases
- Prior ipsilateral breast or thoracic radiation
- Autoimmune conditions with associated radiation risks
NCT07032545
Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors
Organization/Sponsor: University of Maryland, Baltimore
Example patient: A 52-year-old obese woman with BMI 34 kg/m², 18 months post-chemotherapy and radiation for Stage II breast cancer, willing to modify her diet.
Phase N/A
NCT07032545
Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors
Organization/Sponsor: University of Maryland, Baltimore
Example patient: A 52-year-old obese woman with BMI 34 kg/m², 18 months post-chemotherapy and radiation for Stage II breast cancer, willing to modify her diet.
Phase N/A
Interventions
-
Dietary Supplement: Broccoli microgreen (BMG)
Summary: Broccoli microgreens are nutrient-rich plants with potential antioxidant and anti-inflammatory mechanisms studied for cancer prevention benefits in obese breast cancer survivors (Source: Web Search).
Key Inclusion
- Female
- Breast cancer diagnosis Stage I-III
- 2 to 60 months post-curative treatment
- BMI greater than 30 kg/m²
- Willing to avoid cruciferous vegetables during study
Key Exclusion
- Contraindications to nutrition intervention
- GI conditions
- Pregnancy or breastfeeding
- Recent eating disorder history
- Allergy or intolerance to cruciferous vegetables
- Currently taking broccoli extract supplements
NCT06963905
Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer Genomic-based
Organization/Sponsor: Yale University
Example patient: A 52-year-old woman with metastatic triple-negative breast cancer (ER/PgR/HER2-negative, PD-L1 CPS 15) who progressed after first-line pembrolizumab plus chemotherapy, ECOG PS 1, with adequate organ function and no active autoimmune disease.
Phase 1
NCT06963905
Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer Genomic-based
Organization/Sponsor: Yale University
Example patient: A 52-year-old woman with metastatic triple-negative breast cancer (ER/PgR/HER2-negative, PD-L1 CPS 15) who progressed after first-line pembrolizumab plus chemotherapy, ECOG PS 1, with adequate organ function and no active autoimmune disease.
Phase 1
Interventions
-
Biological: Nivolumab
Summary: A fully human IgG4 monoclonal antibody that blocks PD-1 receptor, preventing binding to PD-L1 and PD-L2, thereby activating T-cells and enhancing immune responses against tumor cells (FDA label, NCI Thesaurus). -
Biological: Sacituzumab Govitecan
Summary: An antibody-drug conjugate combining humanized anti-TROP2 antibody with SN-38 topoisomerase inhibitor, enabling targeted delivery to TROP2-expressing cancer cells for DNA damage and apoptosis (FDA label, NCI Thesaurus). -
Biological: Relatlimab FDC + Nivolumab
Summary: Fixed-dose combination of nivolumab (anti-PD-1) and relatlimab (anti-LAG-3) providing dual checkpoint inhibition to enhance T-cell activation and anti-tumor immune responses (FDA label, NCI Thesaurus).
Key Inclusion
- Metastatic triple-negative breast cancer (HER2-negative, ER/PgR <10%)
- PD-L1 positive (CPS >10 by SP263 assay)
- Up to one prior line of systemic cytotoxic chemotherapy with pembrolizumab in metastatic setting
- Prior immune checkpoint inhibition with chemotherapy required
- Documented radiologic progression or intolerance to prior therapy
- ECOG performance status 0 or 1
- LVEF ≥50% within 6 months
- Age 18 years or older
Key Exclusion
- Prior treatment with relatlimab, LAG-3 targeted agents, or sacituzumab govitecan
- Active autoimmune disease requiring immunomodulatory therapy in past 2 years
- History of myocarditis or pneumonitis requiring >28 days steroids
- Clinically active or symptomatic CNS metastases requiring corticosteroids
- HIV with detectable viral load or CD4 <200, active hepatitis B or C
- Cardiac disease (unstable angina, MI, CHF) within 6 months
- Unresolved toxicities >grade 1 from prior therapy
- Pregnant or lactating
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+/ISH-negative) metastatic breast cancer with liver and bone metastases, ECOG 1, who progressed after two prior chemotherapy regimens and has adequate cardiac and organ function.
Phase 2
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+/ISH-negative) metastatic breast cancer with liver and bone metastases, ECOG 1, who progressed after two prior chemotherapy regimens and has adequate cardiac and organ function.
Phase 2
Interventions
-
Drug: ARX788
Summary: An antibody-drug conjugate targeting HER2 with site-specific conjugation to opadotin, a microtubule inhibitor. Upon binding HER2 on tumor cells and internalization, opadotin inhibits tubulin polymerization causing G2/M arrest and apoptosis in HER2-expressing cancers (NCI Thesaurus). -
Drug: Amiloride
Summary: A potassium-sparing diuretic that inhibits sodium channels in distal tubules and collecting ducts. Used topically as eye drops in this trial, likely for prophylaxis of ocular toxicity from ARX788 (FDA label, NCI Thesaurus). -
Procedure: Biospecimen Collection
Summary: Collection of biological samples for testing, diagnostic, or research purposes including biomarker analysis and HER2 status evaluation (NCI Thesaurus). -
Diagnostic Test: Computed Tomography (CT)
Summary: Imaging method using X-rays and computer reconstruction to create cross-sectional scans for tumor assessment per RECIST v1.1 criteria (NCI Thesaurus).
Key Inclusion
- HER2-low breast cancer (IHC 1+ or 2+ without gene amplification)
- Locally advanced unresectable or metastatic disease
- At least one prior line of chemotherapy or ADC for advanced disease
- ECOG performance status 0-2
- At least one measurable lesion per RECIST v1.1
- LVEF ≥50% or institutional lower limit
- Adequate organ function (ANC ≥1.0, platelets ≥100K, creatinine ≤1.5x ULN)
- Stable treated brain metastases allowed
Key Exclusion
- Prior treatment with ARX-788 or auristatin analogues
- History of interstitial lung disease or pneumonitis
- Clinically significant ocular disease (excluding glaucoma)
- Leptomeningeal carcinomatosis
- Myocardial infarction or unstable cardiac disease within 6 months
- QTcF >470 msec (females) or >450 msec (males)
- Active systemic infection including symptomatic COVID-19
- Pregnancy or breastfeeding
NCT07277738
Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial) Genomic-based
Organization/Sponsor: Washington University School of Medicine
Example patient: A 42-year-old woman with heterogeneously dense breasts on her first screening mammogram, MRS risk score of 4.5%, no BRCA mutations, and no prior breast MRI.
Phase N/A
NCT07277738
Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial) Genomic-based
Organization/Sponsor: Washington University School of Medicine
Example patient: A 42-year-old woman with heterogeneously dense breasts on her first screening mammogram, MRS risk score of 4.5%, no BRCA mutations, and no prior breast MRI.
Phase N/A
Interventions
-
Diagnostic Test: MRI
Summary: Imaging using radiofrequency waves and strong magnetic fields to provide detailed pictures of internal organs and tissues, valuable for diagnosing cancer and other pathologic conditions (NCI Thesaurus). -
Diagnostic Test: Mammogram
Summary: Low voltage X-ray photograph of the breast used to detect breast cancer and diagnose benign breast conditions such as fibroadenoma, mastitis, abscess, and cysts (NCI Thesaurus). -
Diagnostic Test: Prognosia Breast
Summary: Risk assessment tool for calculating breast cancer risk estimates.
Key Inclusion
- Normal screening mammogram within 90 days prior to enrollment
- Dense breasts (Class C or D density)
- MRS risk estimate >3% 5-year risk of breast cancer
- Female
- Between 25 and 55 years of age
Key Exclusion
- More than 1 prior mammogram
- Contraindication to MRI with contrast
- Prior or concurrent breast cancer or LCIS
- Prior MRI screening of the breast
- BRCA 1/2 positive or other high penetrance genetic markers
- Receiving chemoprevention
- Breast implants
- Breastfeeding
NCT07285044
Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas
Organization/Sponsor: Mayo Clinic
Example patient: A 62-year-old woman with metastatic breast cancer receiving trastuzumab and pertuzumab, ECOG PS 1, living in the Florida Panhandle with Wi-Fi access and stable social support, tolerating treatment well without significant adverse reactions.
Phase 2
NCT07285044
Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas
Organization/Sponsor: Mayo Clinic
Example patient: A 62-year-old woman with metastatic breast cancer receiving trastuzumab and pertuzumab, ECOG PS 1, living in the Florida Panhandle with Wi-Fi access and stable social support, tolerating treatment well without significant adverse reactions.
Phase 2
Interventions
-
Procedure: Questionnaire Administration
Summary: The act of having an individual fill out a questionnaire for data collection and assessment purposes (NCI Thesaurus). -
Procedure: Cancer Therapeutic Procedure
Summary: Any intervention for management of a malignant neoplasm, including standard-of-care regimens such as immunotherapy, chemotherapy, hormonal therapy, or targeted agents (NCI Thesaurus).
Key Inclusion
- Histologically confirmed malignancy receiving eligible standard-of-care treatment regimen
- Age 18 years or older
- ECOG performance status 0-3
- Adequate tolerability of current treatment without significant drug-related reactions
- Resides within Florida Panhandle and surrounding area serviced by at-home healthcare supplier
- Wi-Fi connection available at patient residence
- Plans to continue eligible treatment for at least 12 weeks
- Social stability screener indicates appropriateness for CCBW program
Key Exclusion
- Co-morbid systemic illnesses or severe concurrent disease interfering with safety assessment
- Receiving investigational agent for primary neoplasm treatment
- Requires continuous 24/7 assistance with daily living without available caregiver support
- Current inpatient hospitalization excluding Advanced Care at Home program
NCT07224464
Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.
Organization/Sponsor: New Phase Ltd.
Example patient: A 62-year-old woman with metastatic colorectal cancer in the abdomen who has failed multiple chemotherapy lines, has ECOG status 1, no brain metastases, and can tolerate lying supine with arms overhead.
Phase N/A
NCT07224464
Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.
Organization/Sponsor: New Phase Ltd.
Example patient: A 62-year-old woman with metastatic colorectal cancer in the abdomen who has failed multiple chemotherapy lines, has ECOG status 1, no brain metastases, and can tolerate lying supine with arms overhead.
Phase N/A
Interventions
-
Device: The Sarah Nanotechnology System
Summary: A nanotechnology-based system that delivers thermal energy via alternating magnetic field to induce hyperthermia for thermal destruction of malignant cells in advanced metastatic solid tumors (NCI Thesaurus).
Key Inclusion
- Histologically confirmed advanced metastatic solid tumors between thoracic inlet and pelvic floor
- Progressed on or after standard therapy
- Measurable disease per RECIST 1.1
- Exhausted all standard treatment options
- Age ≥18 years
- ECOG performance status ≤2
- Rib cage circumference ≤90 cm
- No brain metastases confirmed by imaging within 30 days
Key Exclusion
- Chemotherapy, radiotherapy or hormonal therapy within 14 days
- Immunotherapy or investigational agent within 21 days
- Residual toxicities >Grade 1 from prior therapy
- Presence or history of brain metastases
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Electronic or electronically conductive implants or metals in body
- Unable to lay down with hands extended over head
NCT07222267
A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors
Organization/Sponsor: BeOne Medicines
Example patient: A 58-year-old postmenopausal woman with metastatic ER-positive breast cancer who has received two prior lines of chemotherapy and has measurable disease with ECOG status 1.
Phase 1
NCT07222267
A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors
Organization/Sponsor: BeOne Medicines
Example patient: A 58-year-old postmenopausal woman with metastatic ER-positive breast cancer who has received two prior lines of chemotherapy and has measurable disease with ECOG status 1.
Phase 1
Interventions
-
Drug: BG-75202
Summary: BG-75202 is a KAT6A/B inhibitor targeting proteins that promote cancer growth, being studied for treating breast cancer with promising early antitumor activity (Source: Summary of Web Search). -
Drug: Aromatase Inhibitor
Summary: Inhibits aromatase enzyme responsible for converting androgenic precursors into estrogens, suppressing estrogen-regulated processes in hormone-sensitive cancers (Source: NCI Thesaurus). -
Drug: Estrogen Receptor Antagonist
Summary: Inactivates both AF1 and AF2 transcriptional activation functions of the estrogen receptor to block estrogen signaling (Source: NCI Thesaurus). -
Drug: CDK4 Inhibitor
Summary: Inhibits cyclin-dependent kinase 4, a serine/threonine kinase involved in cell cycle progression, to block cancer cell proliferation (Source: NCI Thesaurus).
Key Inclusion
- Advanced or metastatic breast cancer and other solid tumors
- Exhausted or intolerant of standard therapies
- 1 to 3 prior lines of systemic therapy in metastatic setting
- Postmenopausal or receiving ovarian function suppression
- Measurable disease by RECIST v1.1
- ECOG Performance Status 0 or 1
- Adequate organ function
- CDK4/6 inhibitor naive in specific cohorts
Key Exclusion
- Prior exposure to KAT6A/B or KAT7 inhibitors/degraders
- Active leptomeningeal disease
- Uncontrolled or untreated brain metastasis
- Any malignancy within 3 years before screening except study cancer
NCT07217990
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer Genomic-based
Organization/Sponsor: Ohio State University Comprehensive Cancer Center
Example patient: A 52-year-old woman with early-stage HER2-positive breast cancer (cT2N0) scheduled for neoadjuvant chemotherapy followed by surgery and radiation therapy.
Phase N/A
NCT07217990
Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer Genomic-based
Organization/Sponsor: Ohio State University Comprehensive Cancer Center
Example patient: A 52-year-old woman with early-stage HER2-positive breast cancer (cT2N0) scheduled for neoadjuvant chemotherapy followed by surgery and radiation therapy.
Phase N/A
Interventions
-
Procedure: Biospecimen Collection
Summary: Collection of biological samples for testing, diagnostic, propagation, treatment or research purposes (NCI Thesaurus). -
Procedure: Biopsy
Summary: Removal of tissue specimens or fluid from the body for microscopic examination to establish a diagnosis (NCI Thesaurus). -
Procedure: Breast Cancer Surgery
Summary: Surgical removal of the breast or breast tissue for cancer treatment (NCI Thesaurus). -
Diagnostic Test: MRI
Summary: Imaging using radiofrequency waves and magnetic field to provide detailed pictures of internal organs for diagnosis of cancer and other conditions (NCI Thesaurus). -
Procedure: Radiation Therapy
Summary: Treatment using radiation exposure to target or whole body, often used as curative therapy for cancer (NCI Thesaurus). -
Drug: Neoadjuvant Chemotherapy
Summary: Chemotherapy administered prior to primary treatment to shrink tumors before surgery or radiation (NCI Thesaurus).
Key Inclusion
- Early-stage breast cancer cT1-3 N0 or cT1-2 N1
- HER2-positive or triple negative breast cancer tumor subtype
- Planning to receive neoadjuvant chemotherapy and radiation therapy
- Age 18 years or older
- Willingness to comply with study procedures
Key Exclusion
- Pregnancy or lactation
- Inmate or prisoner status
- Treatment with investigational drug or intervention during breast cancer treatment
- Skin involvement
- Distant metastases
NCT07264790
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction Genomic-based
Organization/Sponsor: Duke University
Example patient: A 42-year-old woman with BRCA1 mutation undergoing bilateral prophylactic mastectomy with immediate reconstruction, no cancer history, and not pregnant.
Phase N/A
NCT07264790
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction Genomic-based
Organization/Sponsor: Duke University
Example patient: A 42-year-old woman with BRCA1 mutation undergoing bilateral prophylactic mastectomy with immediate reconstruction, no cancer history, and not pregnant.
Phase N/A
Interventions
-
Other: Hair mousse
Summary: Hair mousse is a styling product used to add volume and hold to hair by providing texture and grip to hair fibers, not used as a treatment for breast cancer (Summary of Web Search). -
Drug: Minoxidil
Summary: Minoxidil is an arteriolar vasodilator that opens ATP-sensitive potassium channels to relax smooth muscle and reduce peripheral vascular resistance, indicated for resistant hypertension and hair growth stimulation by increasing cutaneous blood flow (FDA label, NCI Thesaurus).
Key Inclusion
- Female sex > 18 years old
- Genetic predisposition to cancer
- Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
- Capable of giving informed consent
Key Exclusion
- Diagnosis of breast cancer
- History of cancer
- Currently pregnant or planning to be pregnant
- Male sex
NCT07311993
A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer
Organization/Sponsor: Cellectar Biosciences, Inc.
Example patient: A 52-year-old woman with metastatic triple negative breast cancer who progressed after chemotherapy and immunotherapy, with ECOG status 1, adequate organ function, and measurable lung metastases.
Phase 1
NCT07311993
A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer
Organization/Sponsor: Cellectar Biosciences, Inc.
Example patient: A 52-year-old woman with metastatic triple negative breast cancer who progressed after chemotherapy and immunotherapy, with ECOG status 1, adequate organ function, and measurable lung metastases.
Phase 1
Interventions
-
Drug: CLR 125
Summary: Sodium Iothalamate I-125 injection (GLOFIL-125) is a radioactive diagnostic agent delivering I-125 radiolabel through radiopharmaceutical activity, indicated for evaluating glomerular filtration rate to diagnose and monitor renal disease (FDA label). -
Drug: Iopofosine I 131
Summary: A radioconjugate of iopofosine labeled with iodine I-131 that selectively accumulates in tumor cells due to decreased phospholipase D activity, delivering cytotoxic radiation specifically to tumor cells (NCI Thesaurus).
Key Inclusion
- Triple negative breast cancer (ER and PR <10%, HER-2 negative)
- Progressed after at least one prior standard therapy
- Age ≥18 years
- ECOG performance status 0-2
- At least one measurable lesion per RECIST v1.1
- Platelets ≥75,000/uL, ANC ≥1500/uL, hemoglobin ≥9 g/dL
- eGFR ≥30 mL/min/1.73 m2
- AST/ALT ≤2.5× ULN, bilirubin <1.5× ULN
Key Exclusion
- Antitumor therapy within three half-lives of study drug
- Prior targeted radiotherapy
- Prior external beam radiation to >20% bone marrow receiving >20 Gy
- Ongoing Grade 2+ toxicities from previous therapies (except alopecia)
- Prior or concurrent malignancy other than TNBC (with specific exceptions)
- Serious organ system dysfunction compromising safety
- Known HIV or uncontrolled active infection
- Pregnancy or breast-feeding
NCT07001241
Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation
Organization/Sponsor: University of Colorado, Denver
Example patient: A 62-year-old woman living in rural Colorado who completed chemotherapy and radiation for breast cancer 18 months ago, currently on maintenance hormonal therapy, experiencing moderate fatigue, with access to home internet.
Phase N/A
NCT07001241
Effects of a Telehealth Exercise Program for Rural Cancer Survivors With Cancer-related Fatigue Including Integrated Longitudinal Assessments of Objective Physical Function and Fatty Acid Oxidation
Organization/Sponsor: University of Colorado, Denver
Example patient: A 62-year-old woman living in rural Colorado who completed chemotherapy and radiation for breast cancer 18 months ago, currently on maintenance hormonal therapy, experiencing moderate fatigue, with access to home internet.
Phase N/A
Interventions
-
Behavioral: Telehealth Exercise Program
Summary: Remote health care delivery using computers and video-conferencing equipment to provide exercise intervention for cancer survivors, source NCI Thesaurus.
Key Inclusion
- Age 18 to 90 years
- Diagnosis of breast or prostate cancer
- Completed curative treatment >3 months and <5 years prior
- Treatment included hormonal, radiation, chemotherapy, or immunotherapy
- Rural zip code per HRSA definition
- Moderate fatigue >3/10
- Access to high-speed internet and smartphone or laptop with camera
- Physician clearance for exercise if indicated by PAR-Q+
Key Exclusion
- ECOG Performance Status ≥2
- Current or planned cancer treatments in next 6 months except maintenance hormonal therapy
- Prostate cancer patients currently on ADT or with ≥12 months prior ADT
- Plans to relocate to non-rural location in 6 months
- Disease or condition preventing safe exercise participation
- Metabolic disease except pre-diabetes, metabolic syndrome, or diabetes managed with metformin only
- Current participation in another exercise oncology program
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 ER+/HER2-negative breast cancer harboring a PIK3CA H1047R mutation detected in tumor biopsy, with bone and liver metastases, no diabetes, and no prior systemic therapy 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 ER+/HER2-negative breast cancer harboring a PIK3CA H1047R mutation detected in tumor biopsy, with bone and liver metastases, no diabetes, and no prior systemic therapy for advanced disease.
Phase 3
Interventions
-
Drug: LY4064809
Summary: Orally bioavailable, brain-penetrant selective inhibitor of PIK3CA H1047X mutant that allosterically binds to prevent PI3K/Akt/mTOR pathway activation, inducing apoptosis and growth inhibition in PIK3CA H1047X mutant-expressing tumor cells (NCI Thesaurus). -
Drug: Fulvestrant
Summary: Synthetic estrogen receptor antagonist that competitively binds to estrogen receptors causing receptor deformation and decreased estrogen binding, inhibiting growth of tamoxifen-resistant, estrogen-sensitive breast cancer cells; administered intramuscularly (FDA label, NCI Thesaurus). -
Drug: Exemestane
Summary: Irreversible steroidal aromatase inhibitor that binds and inhibits aromatase enzyme, blocking peripheral aromatization of androgens to estrogens, thereby lowering estrogen levels in postmenopausal women with hormone-dependent breast cancer (FDA label, NCI Thesaurus). -
Drug: Letrozole
Summary: Nonsteroidal aromatase inhibitor that selectively and reversibly inhibits aromatase enzyme, blocking conversion of androgens to estrogens, resulting in growth inhibition of estrogen-dependent breast cancer cells in postmenopausal women (FDA label, NCI Thesaurus). -
Drug: Anastrozole
Summary: Nonsteroidal aromatase inhibitor that selectively binds and reversibly inhibits aromatase enzyme, blocking aromatization of androgens to estrogens, thereby inhibiting tumor growth in estrogen-dependent breast cancers in postmenopausal women (FDA label, NCI Thesaurus). -
Drug: Abemaciclib
Summary: Orally available CDK4/6 inhibitor that inhibits retinoblastoma protein phosphorylation, preventing G1-S phase transition and arresting cell cycle in G1 phase, suppressing DNA synthesis and inhibiting cancer cell growth (FDA label, NCI Thesaurus). -
Drug: Palbociclib
Summary: Orally available CDK4/6 inhibitor that inhibits retinoblastoma protein phosphorylation early in G1 phase, arresting cell cycle and suppressing DNA replication; also acts as CYP3A inhibitor requiring monitoring for drug interactions (FDA label, NCI Thesaurus). -
Drug: Ribociclib
Summary: Orally available CDK4/6 inhibitor that inhibits cyclin D1/CDK4 and cyclin D3/CDK6 pathways, preventing retinoblastoma phosphorylation and G1-S transition, thereby arresting cell cycle and inhibiting cancer cell growth; also acts as CYP3A inhibitor (FDA label, NCI Thesaurus). -
Other: Placebo
Summary: Inactive compound identical in appearance to active treatment, used to distinguish drug action from suggestive effects in double-blind experimental research (NCI Thesaurus).
Key Inclusion
- HR+/HER2- or HR+/HER2-low locally advanced or metastatic breast cancer
- PIK3CA mutation detected in tumor or blood samples
- Measurable disease or non-measurable evaluable bone disease
- Part 1: 0-2 prior systemic treatments for advanced disease, up to 1 with chemotherapy
- Part 2 Population 1: Endocrine sensitive (de novo advanced or relapsed >12 months after adjuvant ET)
- Part 2 Population 2: Endocrine resistant (relapsed ≤12 months after adjuvant ET, or >12 months after CDK4/6 inhibitor)
- Pre/perimenopausal patients must use GnRH agonist for ovarian suppression
- Male patients with ER+ breast cancer must use GnRH agonist
Key Exclusion
- Type 1 or Type 2 diabetes with HbA1c ≥8%, FBG ≥140 mg/dL, or requiring insulin
- Inflammatory or metaplastic breast cancer
- Leptomeningeal disease or carcinomatous meningitis
- Untreated or active CNS metastases (unless asymptomatic, treated, stable ≥28 days)
- Antineoplastic therapy within 14 days or 4 half-lives (max 28 days washout)
- Immunodeficiency or systemic steroids >10 mg prednisone equivalent within 7 days
- Pregnant, breastfeeding, or intending pregnancy within 6 months of last dose
- Intending pregnancy within 2 years after last fulvestrant/CDK4/6 inhibitor dose
NCT07227233
Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors. Genomic-based
Organization/Sponsor: University of California, San Diego
Example patient: A 52-year-old woman with metastatic HR+ HER2- breast cancer who progressed after 8 months of palbociclib plus letrozole, has ECOG status 1, recent NGS testing showing palbociclib-sensitive mutations, and no prior chemotherapy in the metastatic setting.
Phase N/A
NCT07227233
Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors. Genomic-based
Organization/Sponsor: University of California, San Diego
Example patient: A 52-year-old woman with metastatic HR+ HER2- breast cancer who progressed after 8 months of palbociclib plus letrozole, has ECOG status 1, recent NGS testing showing palbociclib-sensitive mutations, and no prior chemotherapy in the metastatic setting.
Phase N/A
Interventions
-
Treatment Selection: Treatment of physician's choice
Summary: Standard or best treatment based on criteria appropriate for the particular patient (NCI Thesaurus). -
Combination Therapy: A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant
Summary: Alternative CDK4/6 inhibitor combined with fulvestrant targets cell cycle and hormone signaling by blocking estrogen receptors and inhibiting cell division in hormone receptor-positive breast cancer (Web Search Summary).
Key Inclusion
- HR+ HER2- advanced breast cancer per ASCO/CAP guidelines
- Endocrine-sensitive disease per ABC7 2023 guideline
- Progression after minimum 6 months of 1 prior CDK4/6 inhibitor therapy in metastatic setting
- Next-generation sequencing panel testing available on tumor tissue within 6 months after CDK4/6 inhibitor exposure
- Palbociclib sensitive disease per palbo-VNN model
- Zero to 1 prior line of chemotherapy or antibody-drug conjugates in metastatic setting
- ECOG performance status 0-2
- Age >18 years
Key Exclusion
- Life expectancy less than 6 months
- Medical or psychiatric condition preventing safe use of CDK4/6 inhibitor or fulvestrant
- Uncontrolled intercurrent illness including active infection or unstable cardiac disease
- Unable to access abemaciclib, palbociclib, ribociclib, or fulvestrant as standard of care
- Pregnancy or lactation
NCT04529044
A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer
Organization/Sponsor: OHSU Knight Cancer Institute
Example patient: A 52-year-old woman with metastatic HR+/HER2- breast cancer progressing after endocrine therapy, CDK4/6 inhibitor, and two chemotherapy lines, with SSTR-positive liver and bone metastases on 68Ga-DOTATATE PET scan.
Phase II
NCT04529044
A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer
Organization/Sponsor: OHSU Knight Cancer Institute
Example patient: A 52-year-old woman with metastatic HR+/HER2- breast cancer progressing after endocrine therapy, CDK4/6 inhibitor, and two chemotherapy lines, with SSTR-positive liver and bone metastases on 68Ga-DOTATATE PET scan.
Phase II
Interventions
-
Diagnostic Imaging: Positron Emission Tomography
Summary: Imaging technique measuring gamma radiation from electron-positron collisions using radionuclide-labeled metabolically active substances to reveal tissue location and activity in fine detail (NCI Thesaurus). -
Radiopharmaceutical: Lutetium Lu 177 Dotatate
Summary: Radiolabeled somatostatin analog that binds somatostatin receptors (especially SSTR2) on tumor cells, delivering targeted beta radiation therapy via lutetium-177 to treat receptor-positive tumors (FDA label, NCI Thesaurus). -
Radiopharmaceutical Diagnostic: Gallium Ga 68-DOTATATE
Summary: PET imaging agent with gallium-68-labeled somatostatin analog that binds SSTR2 receptors on neuroendocrine and other tumors for diagnostic visualization (FDA label, NCI Thesaurus). -
Diagnostic Imaging: Computed Tomography
Summary: X-ray imaging method using computer reconstruction to create cross-sectional scans of internal body structures along a single axis (NCI Thesaurus). -
Procedure: Biospecimen Collection
Summary: Collection of biological samples for testing, diagnostic, or research purposes (NCI Thesaurus). -
Procedure: Biopsy
Summary: Removal of tissue specimens or fluid from living body for microscopic examination to establish diagnosis (NCI Thesaurus).
Key Inclusion
- Metastatic breast cancer (stage IV or recurrent with distant metastases)
- Disease progression after at least two lines of standard treatment or one cytotoxic chemotherapy
- SSTR-positive tumors (>50% lesions with DOTATATE uptake equivalent to liver)
- At least one measurable RECIST v1.1 lesion amenable to biopsy
- ECOG performance status ≤2
- Adequate organ function (hemoglobin ≥8 g/dL, ANC ≥2.0×10^9/L, platelets ≥75×10^9/L)
- Creatinine clearance ≥51 mL/min
- Consent to pre-treatment screening biopsy
Key Exclusion
- Prior peptide receptor radionuclide therapy
- External beam radiation to >25% bone marrow
- Concurrent somatostatin analog therapy that cannot be interrupted
- Uncontrolled brain metastases
- Recent chemotherapy, targeted therapy, or investigational agent within 4 weeks
- Surgery or radiofrequency ablation within 12 weeks
- Uncontrolled infection, diabetes, or cardiac disease
- Pregnancy or breastfeeding
NCT07308717
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
Organization/Sponsor: Memorial Sloan Kettering Cancer Center
Example patient: A 52-year-old woman undergoing unilateral mastectomy with ambulatory extended recovery at Memorial Sloan Kettering's Josie Robertson Surgical Center.
Phase N/A
NCT07308717
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
Organization/Sponsor: Memorial Sloan Kettering Cancer Center
Example patient: A 52-year-old woman undergoing unilateral mastectomy with ambulatory extended recovery at Memorial Sloan Kettering's Josie Robertson Surgical Center.
Phase N/A
Interventions
-
Procedure: Modification to Pre-operative Order Set
Summary: Modification to pre-operative order set incorporating gabapentin to reduce neuropathic pain and improve peri-operative pain control in breast cancer surgery patients (Source: Web Search).
Key Inclusion
- Age 18 to 65 years
- Undergoing ambulatory extended recovery mastectomy
- Bilateral or unilateral mastectomy
- Surgery at Josie Robertson Surgical Center
Key Exclusion
- None specified
NCT07122713
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Organization/Sponsor: Stony Brook University
Example patient: A 78-year-old woman with T2N1M0 invasive ductal carcinoma who declined surgery due to medical comorbidities, has no prior breast radiation, and is receiving concurrent endocrine therapy.
Phase N/A
NCT07122713
Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Organization/Sponsor: Stony Brook University
Example patient: A 78-year-old woman with T2N1M0 invasive ductal carcinoma who declined surgery due to medical comorbidities, has no prior breast radiation, and is receiving concurrent endocrine therapy.
Phase N/A
Interventions
-
Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes
Summary: Intensity modulated radiation therapy delivering different dose levels to breast tumor and axillary nodes simultaneously, improving critical structure sparing and treatment efficiency (NCI Thesaurus). -
Radiation: Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor
Summary: Intensity modulated radiation therapy delivering different dose levels to breast tumor and whole breast simultaneously, enabling shorter treatment duration and better biologic effectiveness (NCI Thesaurus).
Key Inclusion
- Biopsy proven invasive carcinoma of the breast (lobular, ductal, or no special type)
- T1-T4, N0-2, M0-1 invasive breast carcinoma
- Cancer deemed unresectable or patient is poor surgical candidate or declines surgery
- Life expectancy greater than 6 months
- Negative pregnancy test for females of reproductive age
Key Exclusion
- Concurrent systemic therapy (except endocrine therapy, HER2-targeted therapy, or immunotherapy)
- Prior radiation to ipsilateral breast or regional nodes
- Inability to receive treatment due to body habitus
NCT07222215
A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA) Genomic-based
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 62-year-old postmenopausal woman with ER-positive, HER2-negative metastatic breast cancer harboring ESR1 Y537S mutation, ECOG PS 1, who progressed after 8 months on palbociclib plus letrozole and has not received chemotherapy for metastatic disease.
Phase II
NCT07222215
A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA) Genomic-based
Organization/Sponsor: Dana-Farber Cancer Institute
Example patient: A 62-year-old postmenopausal woman with ER-positive, HER2-negative metastatic breast cancer harboring ESR1 Y537S mutation, ECOG PS 1, who progressed after 8 months on palbociclib plus letrozole and has not received chemotherapy for metastatic disease.
Phase II
Interventions
-
Drug: Elacestrant
Summary: Elacestrant (ORSERDU) is an oral selective estrogen receptor degrader (SERD) that binds ER causing conformational change and proteosomal degradation, preventing ER-mediated signaling in ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. It also inhibits P-glycoprotein and breast cancer resistance protein to overcome endocrine resistance. FDA-approved for postmenopausal women and men after prior endocrine therapy progression (FDA label, NCI Thesaurus). -
Drug: Capecitabine
Summary: Capecitabine is an oral fluoropyrimidine antimetabolite prodrug converted to 5-fluorouracil in tumor cells, producing metabolites FdUMP and FUTP that inhibit DNA and RNA synthesis. Indicated for colorectal, breast, gastric, esophageal, and pancreatic cancers as monotherapy or combination therapy. Requires monitoring for myelosuppression, hand-foot syndrome, and gastrointestinal toxicity (FDA label, NCI Thesaurus).
Key Inclusion
- ER-positive (≥10%), HER2-negative metastatic or locally recurrent unresectable breast cancer
- ESR1 mutation documented (E380Q, V422del, S436P, L536H/P/R, Y537C/D/N/S, D538G)
- Postmenopausal women or men age ≥18 years
- Prior CDK4/6 inhibitor required unless contraindicated
- Remained on prior endocrine therapy ≥6 months without progression in metastatic setting
- Up to two prior endocrine therapies allowed in advanced disease
- No prior chemotherapy in metastatic setting
- ECOG PS 0-1 with adequate organ function
Key Exclusion
- Prior elacestrant treatment
- Prior chemotherapy in metastatic setting
- Active or symptomatic brain metastases or leptomeningeal disease
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- Rapidly progressive symptomatic visceral disease
- Concurrent strong CYP3A inhibitors or P-glycoprotein/BCRP substrates
- Endocrine/biologic therapy <14 days prior or unrecovered toxicities >Grade 1
- Pregnancy, lactation, or inadequate contraception
NCT07285993
Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging
Organization/Sponsor: Icahn School of Medicine at Mount Sinai
Example patient: A 52-year-old woman with metastatic invasive lobular breast cancer, ECOG status 1, on stable chemotherapy with normal liver and kidney function.
Phase N/A
NCT07285993
Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging
Organization/Sponsor: Icahn School of Medicine at Mount Sinai
Example patient: A 52-year-old woman with metastatic invasive lobular breast cancer, ECOG status 1, on stable chemotherapy with normal liver and kidney function.
Phase N/A
Interventions
-
Diagnostic Test: PET/CT
Summary: PET/CT imaging detects cancer cells, evaluates treatment response and metastasis in breast cancer patients (Web Search). -
Drug: 18F-FDG
Summary: Radioactive glucose analog with high tumor cell uptake that accumulates without further metabolism, enabling PET imaging (NCI Thesaurus). -
Drug: 18F-FAPI-74
Summary: Fluorine-18 labeled FAP inhibitor targeting fibroblast activation protein on tumor cells and cancer-associated fibroblasts for PET imaging (NCI Thesaurus).
Key Inclusion
- Females over 18 years of age
- Invasive lobular breast cancer diagnosis
- Pathologically confirmed metastatic disease
- ECOG performance status 0-2
- No planned change in anticancer therapy between scans
Key Exclusion
- Pregnant or lactating patients
- Cannot undergo PET/CT scanning
- Total serum bilirubin greater than 1.5 times upper limit of normal
- Serum creatinine greater than 1.5 times upper limit of normal
NCT06802172
Modified Title Project 4: Effect of Meal Timing During Cancer Treatment in Alaska Native Patients: A Randomized Clinical Trial Genomic-based
Organization/Sponsor: Fred Hutchinson Cancer Center
Example patient: A 52-year-old Alaska Native woman with newly diagnosed stage II HER2-positive breast cancer, BMI 24, starting neoadjuvant chemotherapy with no prior cancer treatment or neuropathy.
Phase N/A
NCT06802172
Modified Title Project 4: Effect of Meal Timing During Cancer Treatment in Alaska Native Patients: A Randomized Clinical Trial Genomic-based
Organization/Sponsor: Fred Hutchinson Cancer Center
Example patient: A 52-year-old Alaska Native woman with newly diagnosed stage II HER2-positive breast cancer, BMI 24, starting neoadjuvant chemotherapy with no prior cancer treatment or neuropathy.
Phase N/A
Interventions
-
Behavioral: Health coaching
Summary: One-on-one support, mentoring, and coaching services to assist participants in adhering to study protocols and behavioral interventions (NCI Thesaurus). -
Procedure: Biospecimen Collection
Summary: Collection of biological samples for testing, diagnostic, or research purposes to evaluate treatment effects and biomarkers (NCI Thesaurus). -
Other: Questionnaire Administration
Summary: Administration of questionnaires to assess patient-reported outcomes, adherence, and quality of life during the study (NCI Thesaurus). -
Behavioral: Time-restricted eating
Summary: Dietary intervention limiting meal consumption to a specific time window to improve metabolic health, lower insulin levels, and potentially enhance cancer treatment outcomes (Web Search Summary).
Key Inclusion
- Self-identify as Alaska Native or American Indian and eligible for care at ANMC
- Age 21 years or older
- Histologically confirmed rectal cancer stage II, III, or IV (if curative)
- Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III
- BMI at least 18.5 kg/m2
- Plan to receive neoadjuvant therapy
- Completed 4 weeks or less of neoadjuvant treatment prior to enrollment
- Score less than 4 on U.S. Household Food Security Survey or dietitian clearance if score 5 or higher
Key Exclusion
- History of cytotoxic chemotherapy 12 months or less prior to current cancer diagnosis
- Any prior pelvic radiotherapy
- Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
- Receiving parenteral nutrition, enteral feeding, or similar nutritional supplements during study
- Pre-existing grade 3 or higher neuropathy
- Pregnant or breastfeeding
- Currently perform overnight shift work more than one day per week on average
- Strictly adhering to less than 10-hour eating window on most days
NCT07318805
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Organization/Sponsor: Pfizer
Example patient: A 62-year-old woman with metastatic hormone receptor-positive breast cancer who progressed after treatment with letrozole and palbociclib, with ECOG performance status 1, measurable lung metastases, and controlled hypertension.
Phase 1
NCT07318805
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Organization/Sponsor: Pfizer
Example patient: A 62-year-old woman with metastatic hormone receptor-positive breast cancer who progressed after treatment with letrozole and palbociclib, with ECOG performance status 1, measurable lung metastases, and controlled hypertension.
Phase 1
Interventions
-
Biological: Bevacizumab
Summary: Recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF) to block tumor angiogenesis and prevent new blood vessel formation required for tumor growth and metastasis, indicated for multiple advanced cancers including metastatic colorectal cancer (FDA label, NCI Thesaurus). -
Drug: Leucovorin
Summary: Reduced form of folic acid used as rescue agent after high-dose methotrexate, as antidote to folic acid antagonist overdose, and in combination with 5-fluorouracil for advanced colorectal cancer by replenishing folate stores and potentiating 5-FU activity (FDA label, NCI Thesaurus). -
Drug: Oxaliplatin
Summary: Platinum-based chemotherapy organoplatinum complex that forms DNA crosslinks to inhibit DNA replication and transcription, indicated for adjuvant treatment of stage III colon cancer and advanced colorectal cancer in combination with fluorouracil and leucovorin (FDA label, NCI Thesaurus). -
Drug: Fluorouracil
Summary: Antimetabolite fluoropyrimidine analog that inhibits nucleic acid synthesis and thymidylate synthase, incorporating into RNA and DNA to disrupt cancer cell proliferation, indicated for adenocarcinomas of colon, rectum, breast, stomach, and pancreas (FDA label, NCI Thesaurus). -
Biological: Cetuximab
Summary: Recombinant chimeric monoclonal antibody that blocks epidermal growth factor receptor (EGFR) to inhibit tumor cell growth, indicated for head and neck squamous cell carcinoma and K-Ras wild-type or BRAF V600E mutation-positive metastatic colorectal cancer (FDA label, NCI Thesaurus). -
Drug: Fulvestrant
Summary: Synthetic estrogen receptor antagonist that competitively binds estrogen receptors causing receptor deformation and decreased estrogen binding, indicated for hormone receptor-positive, HER2-negative advanced breast cancer in postmenopausal women as monotherapy or with CDK4/6 inhibitors (FDA label, NCI Thesaurus). -
Drug: PF-08032562
Summary: Investigational drug being studied in clinical trials for advanced breast cancer, evaluated for safety and efficacy often in combination with other anti-cancer therapies, with specific targets and mechanisms not publicly disclosed (Web Search Summary).
Key Inclusion
- 18 years of age or older
- Advanced or metastatic breast cancer or colorectal cancer
- Disease progression after at least 1 line of endocrine therapy and CDK4/6 inhibitor (breast cancer cohorts)
- Measurable disease
- ECOG performance status 0 or 1
- Prior chemotherapy and/or targeted therapy if appropriate (colorectal cancer cohorts)
- No prior chemotherapy for advanced or metastatic disease (specific colorectal cohorts)
Key Exclusion
- Active malignancy within 3 years prior to enrollment
- Known symptomatic brain metastases requiring steroids
- Advanced/metastatic symptomatic visceral spread at risk of life-threatening complications
- Prior irradiation to >25% of bone marrow
- Hypertension that cannot be controlled by optimal medical therapy
- Renal impairment
- Hepatic dysfunction
- Active bleeding disorder
NCT07209436
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
Organization/Sponsor: Massachusetts General Hospital
Example patient: A 42-year-old woman with newly diagnosed breast cancer, BMI 28, scheduled for immediate bilateral implant-based reconstruction with no prior radiation, chronic pain conditions, or opioid use.
Phase N/A
NCT07209436
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
Organization/Sponsor: Massachusetts General Hospital
Example patient: A 42-year-old woman with newly diagnosed breast cancer, BMI 28, scheduled for immediate bilateral implant-based reconstruction with no prior radiation, chronic pain conditions, or opioid use.
Phase N/A
Interventions
-
Procedure: Pectoral block
Summary: A peripheral neural block targeting the medial and lateral pectoral nerves for pain control during breast surgery (NCI Thesaurus). -
Procedure: Paravertebral block (single injection)
Summary: A single-injection technique delivering local anesthetic into the paravertebral space near thoracic spinal nerves, producing ipsilateral somatic and sympathetic blockade in the chest or abdomen (NCI Thesaurus).
Key Inclusion
- Adult patient 18 years or older
- Scheduled for unilateral or bilateral immediate implant-based breast reconstruction
- Therapeutic or prophylactic indication
- Willing and capable of providing informed consent
Key Exclusion
- Delayed breast reconstruction
- Allergy or contraindication to local anesthetics
- History of radiation therapy
- Morbid obesity (BMI greater than 40 kg/m2)
- Chronic pain syndrome or central sensitization disorders
- Current chronic opioid use (daily use within 2 weeks before surgery and duration greater than 4 weeks)
- Use of nerve medications in past 6 months including gabapentin or carbamazepine
- History of drug or alcohol abuse
NCT07288359
An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors Genomic-based
Organization/Sponsor: Novartis
Example patient: A 62-year-old postmenopausal woman with HR+/HER2- metastatic breast cancer who progressed on letrozole plus palbociclib as first-line therapy and completed one additional line of endocrine therapy, with measurable lung metastases and adequate organ function.
Phase 1, Phase 2
NCT07288359
An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors Genomic-based
Organization/Sponsor: Novartis
Example patient: A 62-year-old postmenopausal woman with HR+/HER2- metastatic breast cancer who progressed on letrozole plus palbociclib as first-line therapy and completed one additional line of endocrine therapy, with measurable lung metastases and adequate organ function.
Phase 1, Phase 2
Interventions
-
Drug: GVV858
Summary: GVV858 is an investigational agent being studied as monotherapy and combined with endocrine therapy for HR+/HER2- breast cancer; mechanism and targets not publicly disclosed (Web Search). -
Drug: Letrozole
Summary: Letrozole is a third-generation nonsteroidal aromatase inhibitor that blocks estrogen synthesis by inhibiting aromatase enzyme, reducing estrogen levels in postmenopausal women with hormone receptor-positive breast cancer (FDA label, NCI Thesaurus). -
Drug: Fulvestrant
Summary: Fulvestrant is an estrogen receptor antagonist that competitively binds estrogen receptors causing receptor degradation, inhibiting estrogen-dependent breast cancer growth; administered intramuscularly for HR+/HER2- advanced breast cancer (FDA label, NCI Thesaurus).
Key Inclusion
- Age ≥18 years
- HR+/HER2- advanced breast cancer with progression after CDK4/6 inhibitor plus endocrine therapy
- Phase II: no prior chemotherapy or antibody-drug-conjugate for advanced disease
- Measurable disease by RECIST v1.1 or evaluable bone lesions
- Locally advanced or metastatic cancer with CCNE1 amplification
- Metastatic castration-resistant prostate cancer with castrate testosterone levels
- No more than 2-3 prior lines of therapy depending on phase and tumor type
- Adequate bone marrow and organ function
Key Exclusion
- Inadequate bone marrow or organ function
- Uncontrolled heart disease or cardiac repolarization abnormalities
- Symptomatic CNS metastases requiring local therapy or increasing corticosteroids
- Symptomatic visceral disease or visceral crisis
- Concurrent hormone replacement therapy for breast cancer patients
- Pregnant, nursing, or unwilling to use effective contraception
- Recent myocardial infarction or coronary artery bypass graft
- Long QT syndrome or risk factors for Torsades de Pointes
NCT06856499
Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer Genomic-based
Organization/Sponsor: University of Colorado, Denver
Example patient: A 52-year-old woman with BRCA1-mutated high-grade serous ovarian cancer who progressed 4 months after completing platinum-based chemotherapy and prior olaparib maintenance, with measurable peritoneal disease and ECOG PS 1.
Phase 1
NCT06856499
Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer Genomic-based
Organization/Sponsor: University of Colorado, Denver
Example patient: A 52-year-old woman with BRCA1-mutated high-grade serous ovarian cancer who progressed 4 months after completing platinum-based chemotherapy and prior olaparib maintenance, with measurable peritoneal disease and ECOG PS 1.
Phase 1
Interventions
-
Drug: Olaparib
Summary: Olaparib is a PARP inhibitor that blocks DNA repair enzymes, exploiting synthetic lethality in BRCA-mutated or HRD tumors, indicated for ovarian, breast, pancreatic, and prostate cancers (FDA label, NCI Thesaurus). -
Drug: Cirtuvivint
Summary: Cirtuvivint is a CDC-like kinase (CLK/DYRK) inhibitor that targets specific kinases to inhibit cancer cell growth, under investigation in combination therapy for various cancers (Web Search).
Key Inclusion
- Women aged ≥18 years
- High-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Platinum-resistant disease (progression <6 months from last platinum dose)
- Measurable disease by RECIST 1.1
- BRCA mutation and/or tumor HRD positive
- Prior PARP inhibitor as treatment or maintenance
- 1-3 prior lines of systemic therapy including at least one platinum-based regimen
- ECOG PS 0-2
Key Exclusion
- Clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal ovarian tumors
- Platinum refractory disease (progression during or within 4 weeks of platinum therapy)
- Myelodysplastic syndrome or acute myeloid leukemia
- Systemic chemotherapy or radiotherapy within 3 weeks
- Myocardial infarction ≤6 months or uncontrolled cardiac disease
- Untreated or symptomatic CNS metastases
- GI disorder interfering with oral medication absorption
- Persistent toxicities ≥Grade 2 from prior therapy (except alopecia or neuropathy)
NCT07226102
An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
Organization/Sponsor: City of Hope Medical Center
Example patient: A 52-year-old English-speaking woman with stage III triple negative breast cancer diagnosed 4 months ago, currently in remission but experiencing high fear of progression with a score of 38 on the Fear of Progression Short-Form.
Phase N/A
NCT07226102
An E-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer
Organization/Sponsor: City of Hope Medical Center
Example patient: A 52-year-old English-speaking woman with stage III triple negative breast cancer diagnosed 4 months ago, currently in remission but experiencing high fear of progression with a score of 38 on the Fear of Progression Short-Form.
Phase N/A
Interventions
-
Behavioral: Virtual Technology Intervention
Summary: An immersive computer-generated environment for interaction and navigation, used to address fear of cancer progression (NCI Thesaurus). -
Procedure: Survey Administration
Summary: Presentation of surveys or questionnaires to obtain patient responses for assessment purposes (NCI Thesaurus). -
Procedure: Interview
Summary: Structured conversation to gather background, personal details, and opinions from participants (NCI Thesaurus). -
Behavioral: Internet-Based Intervention
Summary: Web-based program designed to alter or eliminate behaviors related to fear of progression (NCI Thesaurus). -
Behavioral: Educational Intervention
Summary: Educational activities intended to prevent disease or alter disease course in cancer patients (NCI Thesaurus). -
Behavioral: Behavioral Intervention
Summary: Operant conditioning using rewards and punishments to help patients manage fear and reduce contribution to painful stimuli (NCI Thesaurus).
Key Inclusion
- Women with stage III or IV gynecologic or breast cancer
- At least 2 months from initial diagnosis
- High-risk disease including carcinosarcoma, triple negative breast cancer
- Fear of Progression Short-Form score ≥34
- Age 18 or older
- Able to read and understand English
- Patients in remission or with progressive disease
Key Exclusion
- Enrolled in hospice
- Major depression as assessed by PHQ-9
- Non-English speaking
- Unable to comply with study procedures
NCT07287917
A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies Genomic-based
Organization/Sponsor: Aminex Therapeutics, Inc.
Example patient: A 58-year-old postmenopausal woman with metastatic ER+/HER2- breast cancer harboring PIK3CA mutation, ECOG 1, who progressed on two prior endocrine therapies and is starting capivasertib with fulvestrant.
Phase 1, Phase 2
NCT07287917
A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies Genomic-based
Organization/Sponsor: Aminex Therapeutics, Inc.
Example patient: A 58-year-old postmenopausal woman with metastatic ER+/HER2- breast cancer harboring PIK3CA mutation, ECOG 1, who progressed on two prior endocrine therapies and is starting capivasertib with fulvestrant.
Phase 1, Phase 2
Interventions
-
Biologic: Pembrolizumab
Summary: Humanized monoclonal antibody blocking PD-1 receptor, enhancing T-cell-mediated immune responses against tumors; FDA-approved for melanoma and multiple solid tumors; may cause immune-related adverse events (FDA label, NCI Thesaurus). -
Drug: Capivasertib
Summary: Oral AKT kinase inhibitor blocking PI3K/AKT signaling; FDA-approved with fulvestrant for HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations after endocrine therapy progression; risks include hyperglycemia and rash (FDA label, NCI Thesaurus). -
Drug: Fulvestrant
Summary: Estrogen receptor antagonist competitively binding ER causing receptor degradation; FDA-approved for HR+/HER2- advanced breast cancer as monotherapy or with CDK4/6 inhibitors; administered intramuscularly with multiple co-solvents (FDA label, NCI Thesaurus). -
Drug: DFMO
Summary: Irreversible ornithine decarboxylase inhibitor blocking polyamine biosynthesis required for tumor cell proliferation and chromatin remodeling; induces apoptosis in cancer cells (NCI Thesaurus). -
Drug: AMXT 1501 Dicaprate
Summary: Oral polyamine transport inhibitor blocking polyamine uptake into tumor microenvironment, inhibiting tumor proliferation and reversing polyamine-mediated immune suppression; investigational agent (NCI Thesaurus).
Key Inclusion
- Age ≥18 years
- ER+ HER2- breast cancer with PIK3CA/AKT1/PTEN alterations progressed on ≥2 endocrine regimens or melanoma progressed on immune checkpoint inhibitor
- BRAF mutant melanoma must have progressed on BRAF/MEK inhibitor
- ECOG performance status 0-1
- Measurable disease by RECIST 1.1
- Adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL)
- Creatinine clearance ≥60 mL/min
- Willing to undergo tumor biopsy if safe and feasible
Key Exclusion
- Active CNS metastases or carcinomatous meningitis (unless stable ≥4 weeks without steroids)
- Active autoimmune disease requiring systemic treatment in past 2 years
- Cardiovascular disease including uncontrolled hypertension, heart failure (EF <50%), arrhythmias, or QTcF >450ms
- Active hepatitis B or C infection
- Prior Adriamycin use
- Unresolved toxicity >Grade 1 from prior therapy
- History of pneumonitis or radiation pneumonitis (for pembrolizumab cohort)
- Allogeneic stem cell or solid organ transplant
NCT06860815
Pilot Study of Cemiplimab and Hepatic Radioembolization in Patients With Liver Dominant Metastatic Breast Cancer
Organization/Sponsor: City of Hope Medical Center
Example patient: A 62-year-old post-menopausal woman with metastatic breast cancer and liver-dominant disease (30% tumor burden) who completed two prior chemotherapy regimens, has stable bone metastases, ECOG performance status 1, and adequate organ function without cirrhosis or autoimmune conditions.
Phase N/A
NCT06860815
Pilot Study of Cemiplimab and Hepatic Radioembolization in Patients With Liver Dominant Metastatic Breast Cancer
Organization/Sponsor: City of Hope Medical Center
Example patient: A 62-year-old post-menopausal woman with metastatic breast cancer and liver-dominant disease (30% tumor burden) who completed two prior chemotherapy regimens, has stable bone metastases, ECOG performance status 1, and adequate organ function without cirrhosis or autoimmune conditions.
Phase N/A
Interventions
-
Radiotherapy: Yttrium Y 90 Resin Microspheres
Summary: Radioisotope yttrium Y 90 encapsulated in resin microspheres that occludes tumor blood vessels and delivers cytotoxic beta radiation when injected into arterial vasculature, causing tumor cell death and regression (NCI Thesaurus). -
Procedure: Transarterial Radioembolization
Summary: Treatment using radioactive microspheres to cause hepatic artery embolization and deliver regional radiotherapy for hepatocellular carcinoma (NCI Thesaurus). -
Diagnostic: Magnetic Resonance Imaging
Summary: Imaging using radiofrequency waves and strong magnetic field to provide detailed pictures of internal organs for diagnosis of cancer and other conditions (NCI Thesaurus). -
Diagnostic: Computed Tomography
Summary: Imaging method using X-rays and computer to construct cross-sectional scans for examining internal body structures (NCI Thesaurus). -
Drug: Cemiplimab
Summary: PD-1 blocking monoclonal antibody that binds PD-1 to prevent interaction with PD-L1/PD-L2, restoring immune function and activating cytotoxic T-cells against tumors; FDA-approved for cutaneous squamous cell carcinoma, basal cell carcinoma, and NSCLC (FDA label, NCI Thesaurus). -
Procedure: Biospecimen Collection
Summary: Collection of biospecimens for testing, diagnostic, or research purposes (NCI Thesaurus). -
Procedure: Biopsy
Summary: Removal of tissue specimens or fluid from living body for microscopic examination to establish diagnosis (NCI Thesaurus).
Key Inclusion
- Metastatic breast cancer previously treated with ≥1 line of chemotherapy in metastatic setting
- Measurable metastatic liver disease with tumor burden <50%
- Candidate for TARE based on interventional radiologist evaluation
- Age ≥18 years with ECOG 0-1
- Post-menopausal status or negative pregnancy test for pre-menopausal women
- Fully recovered from prior anti-cancer therapy to ≤grade 1 (except alopecia)
- Adequate organ function: hemoglobin ≥9.0 g/dL, ANC ≥1500/uL, platelets ≥75000/uL
- No radiographic or clinical evidence of cirrhosis
Key Exclusion
- Prior immunotherapy or anti-PD-1/PD-L1/CTLA4 inhibitor in past 12 months
- Progressing or untreated extra-hepatic metastatic disease
- Portal vein invasion or diffuse metastatic disease (>50% liver tumor burden)
- Active or documented autoimmune/inflammatory disorders requiring immunosuppressive therapy
- Anticancer therapy within 28 days prior to first study dose
- Uncontrolled intercurrent illness or active infection
- History of allogeneic organ transplantation
- Ongoing corticosteroid therapy >10 mg prednisone/day or equivalent
NCT07313306
Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center
Example patient: A 52-year-old English-speaking woman with metastatic breast cancer diagnosed 14 months ago, ambulatory and medically cleared for moderate exercise, receiving ongoing treatment at UNC.
Phase N/A
NCT07313306
Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center
Example patient: A 52-year-old English-speaking woman with metastatic breast cancer diagnosed 14 months ago, ambulatory and medically cleared for moderate exercise, receiving ongoing treatment at UNC.
Phase N/A
Interventions
-
Behavioral: The Real and Heel (GRH)
Summary: A 16-week exercise intervention designed to improve physical activity and quality of life in breast cancer patients, particularly those with metastatic disease, through accessible programs targeting unmet exercise needs (Web Search).
Key Inclusion
- Age > 18 years
- Metastatic breast cancer diagnosed within two years
- Medical clearance for moderate intensity exercise
- Receives ongoing cancer care at enrolling institution
- English speaking
- Willing and able to comply with study procedures
Key Exclusion
- Currently on hospice
- Bed-bound status
- Contraindication to exercise
- Prior participation in GRH since MBC diagnosis