Sophic Logo gordian knotBreast Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026


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1: Summary data from new trials identified for Breast Cancer.


Overview

Number of Trials: 27

These 27 trials investigate diverse interventions for breast cancer, including novel immunotherapies, antibody-drug conjugates, CDK4/6 inhibitors, endocrine therapies, and supportive care strategies. Many trials focus on advanced or metastatic disease, particularly triple-negative and HER2-positive subtypes. Emerging approaches include ctDNA-guided treatment, personalized cancer vaccines, time-restricted eating, probiotics, and AI-enhanced biomarker strategies. Several trials explore rechallenge strategies, neoadjuvant optimization, and prevention interventions such as alcohol counter-marketing and cardiovascular health education.

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 (bone marrow, liver, kidney)
  • Life expectancy ≥3-6 months
  • Prior standard therapy or progression on standard treatment
  • Negative pregnancy test for women of childbearing potential
  • Willingness to use contraception during study
  • Ability to provide informed consent

Common Exclusion

  • Active brain metastases or leptomeningeal disease (unless stable)
  • Uncontrolled intercurrent illness or active infection
  • Pregnant or breastfeeding
  • Known HIV, hepatitis B, or hepatitis C infection (unless controlled)
  • History of autoimmune disease requiring immunosuppression
  • Prior malignancy within 2-5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Significant cardiovascular disease or cardiac dysfunction
  • Recent chemotherapy, radiotherapy, or investigational agents within specified washout period
  • Hypersensitivity to study drugs or components
  • Psychiatric or substance abuse disorders interfering with compliance

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07078604

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer Genomic-based

Organization/Sponsor: University of Washington


Example patient: A 52-year-old woman with metastatic triple-negative breast cancer (ER/PR/HER2-negative, PD-L1-negative), ECOG status 1, with measurable lung metastases and no prior metastatic immunotherapy, eligible for chemotherapy.

Phase II

Interventions

  • Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
    Summary: STEMVAC is a DNA plasmid vaccine targeting overexpressed proteins in breast cancer stem cells to stimulate immune attack against cancer cells, tested in triple-negative breast cancer trials (Summary of Web Search).
  • Biological: Sargramostim
    Summary: Sargramostim is a recombinant GM-CSF that stimulates granulocyte and macrophage production to accelerate myeloid recovery and enhance immune response, used as adjuvant in immunotherapy (FDA label, NCI Thesaurus).
  • Drug: Chemotherapy
    Summary: Chemotherapy uses synthetic or natural drugs to target rapidly dividing cancer cells by interfering with DNA and cell division, often causing side effects (NCI Thesaurus, Web Search).
  • Drug: Carboplatin
    Summary: Carboplatin is a platinum-based chemotherapy that forms DNA cross-links to inhibit cancer cell growth, used in breast and ovarian cancer with reduced toxicity versus cisplatin (FDA label, NCI Thesaurus).
  • Drug: Paclitaxel
    Summary: Paclitaxel is a microtubule inhibitor that disrupts cell division by stabilizing microtubules, inducing apoptosis in breast, ovarian, and lung cancers (FDA label, NCI Thesaurus).
  • Drug: Pegylated Liposomal Doxorubicin Hydrochloride
    Summary: Pegylated liposomal doxorubicin is a chemotherapy agent offering targeted delivery with reduced cardiotoxicity compared to conventional doxorubicin, used in metastatic breast cancer (Web Search).
  • Drug: Eribulin
    Summary: Eribulin is a microtubule dynamics inhibitor derived from marine sponge that disrupts cell division, indicated for metastatic breast cancer after prior chemotherapy (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Doxorubicin is an anthracycline antibiotic that inhibits topoisomerase II and intercalates DNA, causing cell death in breast cancer and other malignancies with cardiotoxicity risk (FDA label, NCI Thesaurus).
  • Drug: Docetaxel
    Summary: Docetaxel is a chemotherapy drug that stabilizes microtubules to inhibit cancer cell division, used in breast cancer including HER2-positive cases (Web Search).
  • Drug: Cisplatin
    Summary: Cisplatin is a platinum-based agent that forms DNA cross-links causing apoptosis, used in testicular, ovarian, and bladder cancers with nephrotoxicity and ototoxicity risks (FDA label, NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection involves gathering tissue and fluid samples for cancer research to analyze genetic and molecular features for targeted therapy development (NCI Thesaurus, Web Search).
  • Procedure: Ultrasound-Guided Biopsy
    Summary: Ultrasound-guided biopsy uses sound waves to locate and remove tissue samples from breast abnormalities for minimally invasive cancer diagnosis (Web Search).
  • Procedure: Computed Tomography Assisted Biopsy
    Summary: CT-assisted biopsy uses computed tomography imaging to guide needle placement for accurate tissue sampling to confirm malignancy or benignity (Web Search).
  • Diagnostic Test: Positron Emission Tomography (PET)
    Summary: PET imaging uses radiotracers to detect cancer, stage disease, and monitor treatment response through visualization of biological processes (NCI Thesaurus, Web Search).
  • Diagnostic Test: Computed Tomography
    Summary: CT scans use X-rays and computer reconstruction to create cross-sectional images for detecting cancer spread and monitoring treatment effectiveness (NCI Thesaurus, Web Search).

Key Inclusion

  • Age ≥18 years
  • ECOG Performance Status ≤2
  • Histologically confirmed triple-negative breast cancer (ER ≤5%, PR ≤5%, HER2-negative or HER2-low)
  • Tumor negative for PD-L1 marker (22C3 pharmDx assay)
  • Metastatic disease measurable by RECIST 1.1
  • At least one biopsy-accessible lesion not used for efficacy measurement
  • No prior cancer immunotherapy in metastatic setting
  • Appropriate candidate for standard chemotherapy per oncologist judgment

Key Exclusion

  • More than one prior therapy line in metastatic setting
  • PD-L1-positive tumors (22C3 pharmDx assay)
  • Enrollment in concurrent interventional clinical trial
  • Cardiac conditions including symptomatic cardiomyopathy, unstable angina, or NYHA class III-IV heart failure
  • Autoimmune disease or conditions requiring chronic systemic steroids or immunosuppressants
  • Known hypersensitivity to GM-CSF adjuvant
  • Non-breast malignancy requiring treatment within 5 years or any B-cell malignancy under surveillance
  • Pregnant or breastfeeding, or known HIV, hepatitis B, or hepatitis C infection

NCT07459673

HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 52-year-old woman with newly diagnosed de novo stage IV HER2 3+ metastatic breast cancer, ECOG 1, LVEF 55%, no prior systemic therapy, with liver and bone metastases measurable by PET scan, deemed potentially operable with good response to therapy.

Phase N/A

Interventions

  • Drug: Trastuzumab deruxtecan-nxki
    Summary: Antibody-drug conjugate targeting HER2-positive breast cancer that delivers a topoisomerase inhibitor to induce DNA damage and apoptosis in cancer cells, effective in treatment-resistant and HER2-low cases (Summary of Web Search).
  • Diagnostic Test: Natera Signatera
    Summary: Personalized blood test detecting circulating tumor DNA to predict treatment response, recurrence risk, and identify molecular residual disease in breast cancer (Summary of Web Search).
  • Diagnostic Test: Personalis NeXT Personal
    Summary: Ultrasensitive liquid biopsy using circulating tumor DNA to detect molecular residual disease and monitor treatment response in breast cancer (Summary of Web Search).

Key Inclusion

  • Age ≥18 years with histologically confirmed unresectable locally advanced or metastatic breast cancer
  • Stage IV at diagnosis (de novo metastatic) per AJCC 8
  • HER2 IHC 3+
  • Life expectancy ≥12 weeks
  • Medically fit for surgery or potentially operable with response to induction therapy
  • Measurable disease per PERCIST 1.0
  • ECOG performance status 0 to 1
  • Adequate organ function including ANC ≥1500/µL, platelets ≥100,000/µL, hemoglobin ≥9.0 g/dL

Key Exclusion

  • HER2 IHC 1-2+ with positive FISH or ISH
  • Prior anti-HER2 therapy or systemic anti-cancer treatment for breast cancer
  • Known CNS metastases or leptomeningeal carcinomatosis
  • Chronic systemic steroid therapy >10 mg daily prednisone equivalent within 7 days
  • Grade ≥3 neuropathy
  • Active infection requiring antibiotics
  • LVEF below institutional normal range of 50%
  • Significant cardiovascular impairment within 12 months including NYHA Class III/IV heart failure, unstable angina, myocardial infarction

NCT04362826

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 52-year-old woman with newly diagnosed invasive ductal carcinoma, 1.5 cm tumor, BMI 26, no recent antibiotic use, willing to avoid probiotic foods during the study.

Phase N/A

Interventions

  • Dietary Supplement: Novel probiotic
    Summary: Novel probiotics modulate gut and breast microbiomes to enhance immune response against breast cancer through immune system modulation and metabolic changes (Summary of Web Search).
  • Other: Placebo
    Summary: Inactive compound identical in appearance to the probiotic treatment, used to distinguish drug action from suggestive effects (NCI Thesaurus).

Key Inclusion

  • Diagnosis of breast cancer (invasive ductal carcinoma or invasive lobular carcinoma)
  • Minimum breast tumor size of 1.0 cm
  • BMI between 18.5 to 29.9 kg/m2
  • Agree to abstain from unpasteurized bacteria-fermented foods one week prior to baseline and throughout study
  • Agree to not change dietary habits or activity levels during study
  • Childbearing potential must use medically approved birth control and have negative pregnancy test

Key Exclusion

  • Pregnant, breastfeeding, or planning pregnancy during trial
  • Use of antibiotics within 5 weeks of randomization
  • History of chronic inflammation or structural abnormality of digestive tract
  • Use of probiotic and/or prebiotic supplements prior to screening and throughout study
  • Receiving other investigational agents within 30 days prior to randomization
  • Change in anti-psychotic medication within 3 months prior to randomization
  • Alcohol or drug abuse in past year
  • Known allergy to test material's active or inactive ingredients

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 disease by palbo-VNN model, and no prior chemotherapy in the metastatic setting.

Phase N/A

Interventions

  • Treatment Strategy: Treatment of physician's choice
    Summary: Various chemotherapy regimens or targeted therapies selected based on patient-specific factors; in ER+ cases may include endocrine therapies or CDK4/6 inhibitors (source: Web Search).
  • Combination Therapy: A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant
    Summary: A second CDK4/6 inhibitor combined with fulvestrant targets HR+ breast cancer by inhibiting cell cycle progression and blocking estrogen signaling after initial CDK4/6 inhibitor therapy (source: Web Search).

Key Inclusion

  • Age >18 years
  • HR+ HER2- advanced breast cancer (unresectable or metastatic)
  • Endocrine-sensitive disease per ABC7 2023 guideline
  • Progression after minimum 6 months of 1 prior CDK4/6 inhibitor therapy in metastatic setting
  • Palbociclib sensitive disease determined by palbo-VNN model
  • Next-generation sequencing panel testing available on tumor tissue collected within 6 months after CDK4/6 inhibitor exposure
  • Zero to 1 prior line of chemotherapy or antibody-drug conjugates in metastatic setting
  • ECOG performance status 0-2

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 decompensated organ failure
  • Unable to access abemaciclib, palbociclib, ribociclib, or fulvestrant as standard of care
  • Pregnancy or lactation
  • Investigational agents within 3 weeks if pharmacokinetic interaction with selected drug

NCT05741164

Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic Triple Negative Breast Cancer

Organization/Sponsor: Emory University


Example patient: A 52-year-old woman with metastatic triple negative breast cancer who progressed on pembrolizumab and chemotherapy, ECOG status 1, with controlled diabetes and no autoimmune disease.

Phase N/A

Interventions

  • Drug: Propranolol
    Summary: Beta-blocker targeting beta-adrenergic receptors to reduce angiogenesis and metastases in breast cancer (Summary of Web Search).
  • Biological: Pembrolizumab
    Summary: Humanized monoclonal antibody blocking PD-1 receptor to enhance T-cell-mediated immune responses against tumor cells, FDA-approved for multiple cancers (FDA label, NCI Thesaurus).
  • Procedure: Questionnaire Administration
    Summary: Patient self-reported outcomes assessment to measure quality of life and treatment effects in breast cancer patients (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: X-ray imaging method creating cross-sectional scans to monitor tumor progression and assess treatment effectiveness (NCI Thesaurus, Summary of Web Search).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Summary of Web Search).
  • Procedure: Biopsy
    Summary: Removal of tissue specimens for microscopic examination to establish cancer diagnosis and monitor treatment response (NCI Thesaurus, Summary of Web Search).

Key Inclusion

  • Age >= 18 years
  • Pathologically confirmed unresectable or metastatic triple negative breast cancer
  • Checkpoint inhibitor refractory with disease progression on prior chemotherapy and pembrolizumab
  • ECOG Performance Status <= 1
  • Agreeable to pre- and 6-week post treatment biopsy
  • Measurable disease per RECIST 1.1 criteria
  • HbA1C <= 8.5
  • No chemotherapy, radiotherapy, or major surgery within 4 weeks

Key Exclusion

  • Currently treated with systemic immunosuppressive agents including steroids
  • Active autoimmune disease or history of transplantation
  • Rapidly progressive or symptomatic disease
  • Primary resistance to initial chemotherapy plus checkpoint inhibitor
  • Pregnant or nursing women
  • Symptomatic brain metastases < 4 weeks from radiation
  • Contraindications to beta-blockers including uncontrolled heart failure, severe asthma or COPD
  • Uncontrolled diabetes (HbA1C > 8.5 or fasting glucose > 160 mg/dl)

NCT06434064

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer Genomic-based

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 52-year-old woman with metastatic triple negative breast cancer harboring a TP53 mutation, previously treated with three lines of chemotherapy, ECOG status 1, with normal cardiac function and no history of thrombosis.

Phase II

Interventions

  • Drug: Tamoxifen
    Summary: Tamoxifen is a selective estrogen receptor modulator that blocks estrogen receptors, used to treat hormone receptor-positive breast cancer by inhibiting estrogen effects on breast tissue (Summary of Web Search).
  • Drug: Pegylated Liposomal Doxorubicin Hydrochloride
    Summary: Pegylated liposomal doxorubicin is a chemotherapy agent encapsulated in liposomes for targeted delivery, offering reduced cardiotoxicity compared to conventional doxorubicin, used in metastatic breast cancer (Summary of Web Search).
  • Procedure: Magnetic Resonance Imaging
    Summary: MRI uses radiofrequency waves and magnetic fields to provide detailed images of internal organs and tissues for diagnosis and monitoring of cancer (NCI Thesaurus).
  • Procedure: Echocardiography
    Summary: Echocardiography uses high-frequency sound waves to create images of heart structures for cardiac function assessment (NCI Thesaurus).
  • Procedure: Computed Tomography
    Summary: CT scanning uses X-rays and computer processing to construct cross-sectional images for examining internal body structures and monitoring tumor progression (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection involves gathering tissue and fluid samples for testing, diagnostic, propagation, treatment or research purposes to analyze genetic and molecular features (NCI Thesaurus).
  • Procedure: Biopsy
    Summary: Biopsy is the removal of tissue specimens or fluid from the living body for microscopic examination to establish a diagnosis (NCI Thesaurus).

Key Inclusion

  • Pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%)
  • Previously treated with at least 2 lines of therapy in the metastatic setting
  • Confirmed eligible TP53 genomic alteration by CLIA-approved assay
  • HER-2 negative by IHC 0-1+ or IHC 2+ and FISH negative
  • Age ≥ 18 years
  • ECOG performance status 0-1
  • LVEF ≥ 50% within 30 days prior to enrollment
  • Adequate organ function and blood counts

Key Exclusion

  • Known contraindications to endocrine therapy
  • Chemotherapy, hormonal therapy, immunotherapy, or radiotherapy within 4 weeks prior to Cycle 1 Day 1
  • Hypersensitivity to tamoxifen or similar compounds
  • History of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism
  • Cardiac disease including angina, arrhythmias, myocardial infarction, CHF, or cardiomyopathy
  • Cirrhosis or severe hepatic impairment
  • Pregnant or nursing
  • HIV positivity or AIDS-related illness

NCT07447700

A Pilot Study to Evaluate the Effectiveness of Focused Massage on Pain, Mobility, and Quality of Life During Radiation Treatment for Patients With Breast Cancer

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 52-year-old English-speaking woman with newly diagnosed breast cancer undergoing curative-intent radiation therapy without cognitive impairment or uncontrolled psychiatric conditions.

Phase N/A

Interventions

  • Procedure: upper body massage
    Summary: A therapeutic method involving manipulation, methodical pressure, friction, and kneading of the body to potentially reduce pain and improve mobility during radiation treatment (NCI Thesaurus).

Key Inclusion

  • 18 years of age or older
  • Diagnosis of breast cancer
  • Treatment plan for curative intent radiation
  • Available for focused chair massages post-radiation treatments

Key Exclusion

  • Patients with recurrent breast cancer
  • Patients treated palliatively with radiation
  • Inability to read and/or understand English
  • Documented cognitive disorder limiting ability to complete surveys
  • Major psychiatric disorders not controlled by medication

NCT07483307

Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 62-year-old postmenopausal woman with newly diagnosed 4 cm ER-positive, HER2-negative invasive lobular carcinoma with one positive axillary node, planning breast-conserving surgery without gadolinium allergy.

Phase N/A

Interventions

  • Drug: Neoadjuvant endocrine therapy
    Summary: Targets estrogen receptors in hormone receptor-positive breast cancer using hormone blockers like tamoxifen or aromatase inhibitors to shrink tumors before surgery and improve surgical outcomes (Source: Web Search).

Key Inclusion

  • Postmenopausal women aged ≥50 years
  • Biopsy-proven cT2-T3 N0-1 invasive lobular carcinoma
  • ER+/HER2- subtype (≥10% ER+ nuclei, HER2 IHC 0/1+ or negative ISH)
  • Medically fit for breast-conserving surgery

Key Exclusion

  • Prior ipsilateral breast cancer
  • Advanced regional disease (cN2/cN3) or stage 4 disease
  • Patients who would benefit from neoadjuvant chemotherapy
  • Not candidates for definitive breast surgery
  • Gadolinium allergy precluding breast MRI

NCT07320664

Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 22-year-old woman living in Ohio who drinks alcohol socially several times per month, is not pregnant, and owns a smartphone with texting capabilities.

Phase N/A

Interventions

  • Behavioral: Skin Cancer Risk Messages
    Summary: Tailored messages targeting young adults to reduce skin cancer risk by modifying sun protection and UV exposure behaviors (Summary of Web Search).
  • Behavioral: Alcohol and Breast Cancer Risk Messages
    Summary: Co-created counter marketing messages aimed at reducing alcohol consumption in young women to lower breast cancer risk (Summary of Web Search).

Key Inclusion

  • Assigned female at birth
  • Age 18-25 at enrollment
  • Report drinking alcohol at least once in the past 30 days
  • Not pregnant or intending to become pregnant
  • Reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey
  • Has personal mobile smartphone with texting capabilities

Key Exclusion

  • Assigned male at birth
  • Ages <18 or >25 at enrollment
  • Do not report drinking alcohol at least once in the past 30 days
  • Pregnant or intending to become pregnant
  • Do not reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey
  • Not willing to complete procedures

NCT06802172

Effect of Meal Timing During Cancer Treatment in Patients in Alaska: 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 triple negative breast cancer, BMI 24, starting neoadjuvant chemotherapy, with food security and no prior cancer treatment.

Phase N/A

Interventions

  • Behavioral: Health coaching
    Summary: Health coaching targets breast cancer survivors to improve physical activity, diet, and overall quality of life, showing potential benefits in increasing exercise adherence and enhancing well-being (Summary of Web Search).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for cancer research to analyze genetic and molecular features, helping understand cancer mechanisms and develop targeted therapies (Summary of Web Search, NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Assessment of patient self-reported outcomes including quality of life, psychological and physical impacts, used to gather subjective data on patient experiences and treatment effects (Summary of Web Search, NCI Thesaurus).
  • Behavioral: Time-restricted eating
    Summary: Limiting food intake to an 8-hour window, potentially improving outcomes for cancer patients undergoing chemotherapy through metabolic and hormonal changes, may reduce treatment toxicity (Summary of Web Search).

Key Inclusion

  • Self-identify as Alaska Native or American Indian eligible for care at ANMC
  • Age 21 years or older
  • Stage II-IV rectal cancer or stage I-III HER2+ or triple negative breast cancer
  • BMI at least 18.5 kg/m2
  • Plan to receive neoadjuvant or adjuvant therapy for more than 3 months
  • Completed 4 weeks or less of treatment prior to enrollment
  • Score less than 4 on U.S. Household Food Security Survey or dietitian clearance

Key Exclusion

  • History of cytotoxic chemotherapy within 12 months prior to diagnosis (neoadjuvant)
  • Any prior pelvic radiotherapy
  • Active second malignancy requiring systemic therapy
  • Pre-existing grade 3 or higher neuropathy
  • Pregnant or breastfeeding
  • Currently perform overnight shift work more than 1 day per week
  • Strictly adhering to less than 10-hour eating window on most days
  • Severe psychiatric, cognitive, or substance misuse disorders interfering with adherence

NCT07432633

A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Organization/Sponsor: Blue Earth Diagnostics


Example patient: A 62-year-old woman with newly diagnosed stage IIB invasive lobular breast carcinoma, ECOG 1, scheduled for surgical resection in 3 weeks, with no prior cancer history or autoimmune disorders.

Phase 1, Phase 2

Interventions

  • PET imaging agent: [18F]FPyQCP
    Summary: [18F]FPyQCP is a PET imaging agent targeting fibroblast activation protein in tumor-associated activated fibroblasts for oncology imaging, evaluated in Phase 1/2 trials (Source: Web Search).

Key Inclusion

  • Age 18 to <80 years
  • ECOG performance status ≤2
  • Diagnosis of CRC, GC, PDAC, ILC, or EOC confirmed by histopathology or cytology
  • Cohort A: Stage I-III disease or oligometastatic stage IV (≤5 metastases)
  • Cohort B: Treatment-naïve with at least stage IIB disease or post-neoadjuvant therapy or suspected recurrence
  • Conventional imaging within 8 weeks of [18F]FPyQCP administration
  • Scheduled biopsy or surgical resection no later than Day 42 (Cohort B)
  • Negative pregnancy test for women of childbearing potential

Key Exclusion

  • Radioisotope administration within 5 physical half-lives
  • Other investigational medicinal product within 2 weeks or 5 half-lives
  • Recent contrast agent use (<24 hours IV, <5 days oral)
  • Severe claustrophobia or panic attacks in confined spaces
  • Autoimmune or inflammatory disorder expected to confound imaging
  • Abdomino-pelvic or breast irradiation in last 3 months
  • Significant renal or hepatic impairment
  • Cohort A: Prior history of any other cancer

NCT07354919

A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)

Organization/Sponsor: HealthPartners Institute


Example patient: A 62-year-old man with metastatic castrate-resistant prostate cancer progressed on enzalutamide and docetaxel, currently taking 10mg oral morphine daily for bone pain, with measurable lung metastases and 6-month life expectancy.

Phase 2

Interventions

  • Drug: axelopran
    Summary: Axelopran is an investigational agent being studied for cancer control in phase II trials; its specific mechanism of action has not been publicly disclosed but is being evaluated in patients with advanced cancers on opioids (source: Web Search).

Key Inclusion

  • Adults aged 18 or more with histologically or cytologically proven prostate, breast, pancreatic, or NSCLC carcinoma
  • Advanced stage (locally advanced or metastatic) with no curative-intent therapy planned
  • Relapsed or progressed on or after standard systemic treatment including cytotoxic chemotherapy
  • Current opioid use averaging at least 5mg OME/day over past 3 days
  • At least one measurable lesion meeting RECIST v1.1 criteria
  • Minimum life expectancy of at least 2 months
  • At least 2 weeks since last cancer-directed therapy
  • Willing to delay next line of systemic therapy until day 43 for imaging assessment

Key Exclusion

  • Any previous gastrointestinal surgery except uncomplicated appendectomy or cholecystectomy
  • Active malignancy with direct GI tract extension or invasion
  • Current active untreated brain metastases
  • History of fecal incontinence, inflammatory bowel disease, or intestinal obstruction
  • Use of buprenorphine, alvimopan, naltrexone, methylnaltrexone, naloxone, or related therapies within 14 days
  • Receipt of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
  • Receipt of anti-VEGF therapies within 30 days
  • Pregnant, breastfeeding, or women of childbearing potential without birth control

NCT07300475

Phase 1 Clinical Trial of a Personalized Cancer Immunotherapeutic (PCI) Strategy +/- AB248 (CD8-selective IL-2 Mutein Fusion Protein) in Patients With a New Diagnosis of Triple Negative Breast Cancer Undergoing Neoadjuvant Chemoimmunotherapy Genomic-based

Organization/Sponsor: Washington University School of Medicine


Example patient: A 52-year-old woman with newly diagnosed T2N1 triple-negative breast cancer, ECOG 0, adequate cardiac function, no autoimmune disease, and available tumor tissue for neoantigen prediction.

Phase 1

Interventions

  • Immunomodulator: poly-ICLC
    Summary: Poly-ICLC is an immunomodulator that stimulates immune cells and targets tumor cells, tested in combination with vaccines to enhance immune response against cancer in breast cancer trials (Summary of Web Search).
  • Diagnostic Tool: pVAC tools neoantigen prediction algorithm
    Summary: pVAC tools identifies cancer-specific mutations to predict immune response, crucial for checkpoint blockade therapy and personalized vaccines, targeting point mutations and insertions in breast cancer (Summary of Web Search).
  • Biological: AB248 (CD8-selective IL-2 mutein fusion protein)
    Summary: AB248 is a CD8-selective IL-2 mutein fusion protein that enhances anti-tumor efficacy by targeting CD8+ T cells, showing improved safety over traditional IL-2 therapies, currently in Phase 1 trials (Summary of Web Search).
  • Biological: Personalized cancer immunotherapeutic (PCI)
    Summary: PCI targets CD8+ T cells using IL-2 mutein fusion proteins to enhance immune response against cancer, showing promise in triple-negative and metastatic breast cancer with some complete responses (Summary of Web Search).
  • Drug: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent that cross-links DNA to disrupt cancer cell replication, indicated for breast cancer, lymphomas, leukemias, and other malignancies (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Doxorubicin is an anthracycline antibiotic that intercalates DNA, inhibits topoisomerase II, and generates free radicals, indicated for breast cancer, leukemias, lymphomas, and other cancers (FDA label, NCI Thesaurus).
  • Biological: Pembrolizumab
    Summary: Pembrolizumab is a humanized monoclonal antibody that blocks PD-1 receptor, enhancing T-cell-mediated immune responses against tumors, approved for multiple cancers including triple-negative breast cancer (FDA label, NCI Thesaurus).
  • Drug: Carboplatin
    Summary: Carboplatin is a platinum-based agent that induces DNA cross-links to inhibit cancer cell growth, indicated for ovarian carcinoma and used in breast cancer treatment (FDA label, NCI Thesaurus).
  • Drug: Paclitaxel
    Summary: Paclitaxel is a microtubule inhibitor that disrupts cell division by stabilizing microtubules and inducing apoptosis, indicated for breast cancer, ovarian cancer, lung cancer, and Kaposi's sarcoma (FDA label, NCI Thesaurus).

Key Inclusion

  • Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer
  • At least 18 years of age
  • Adequate tissue available for nucleic acid isolation/PCI design
  • Adequate cardiac function and candidate for KEYNOTE 522 regimen
  • ECOG performance status ≤ 1 (Step 1)
  • Adequate bone marrow and organ function (Step 1)
  • Received at least 4 months of KEYNOTE 522 regimen (Step 1)
  • Use of adequate contraception during study participation

Key Exclusion

  • Prior or concurrent malignancy that may interfere with safety or efficacy assessment
  • Received prior chemotherapy, targeted therapy, or radiation within past 12 months
  • Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Diagnosis of immunodeficiency or receiving immunosuppressive therapy
  • History of pneumonitis requiring steroids or current pneumonitis
  • Pregnant or breastfeeding
  • Known history of HIV, active TB, or detectable HBV/HCV on therapy

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 mammogram, no BRCA mutations, and an MRS-calculated 5-year breast cancer risk of 4%.

Phase N/A

Interventions

  • Diagnostic Test: MRI
    Summary: MRI uses large magnets and radiofrequencies to create detailed breast images, detecting tumors more clearly than mammography, especially in high-risk patients, often doubling mammography sensitivity (Summary of Web Search).
  • Diagnostic Test: Mammogram
    Summary: Mammogram is a screening tool using low-dose X-rays to create breast images for early cancer detection, particularly useful in women with dense breast tissue (Summary of Web Search).
  • Diagnostic Test: Prognosia Breast
    Summary: Prognosia Breast is an FDA Breakthrough Device-designated AI tool that analyzes mammograms to predict five-year breast cancer risk, supporting radiologists in identifying high-risk patients for additional screening (Summary of Web Search).

Key Inclusion

  • Normal screening mammogram within 90 days prior to enrollment
  • Dense breasts (Class C or D density)
  • MRS risk estimate at >3% 5-year risk of breast cancer
  • Female
  • Between 25 and 55 years of age (inclusive)

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
  • Known BRCA 1/2 positive or other high penetrance genetic marker
  • Receiving any chemoprevention
  • Has breast implants
  • Is breastfeeding

NCT07214532

SIgnatera-Guided Initiation of Adjuvant CDK4/6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer Genomic-based

Organization/Sponsor: Natera, Inc.


Example patient: A 52-year-old postmenopausal woman with Stage II ER-positive, HER2-negative, Grade 2 breast cancer with one positive lymph node, status post lumpectomy with negative margins, starting adjuvant endocrine therapy with ctDNA monitoring to guide potential CDK4/6 inhibitor addition.

Phase N/A

Interventions

  • Diagnostic Test: ctDNA-Guided Treatment Strategy
    Summary: Circulating tumor DNA detection in blood, plasma, or serum to guide initiation of CDK4/6 inhibitor therapy in adjuvant setting (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • ER and/or PR positive breast cancer
  • HER2-negative breast cancer
  • Anatomic Stage II with N1 or N0 with T2/T3 and G2-3 and/or Ki67≥20%
  • Complete surgical resection with negative margins
  • Planned adjuvant endocrine therapy for ≥5 years
  • ECOG Performance Status 0 or 1
  • No contraindication to ribociclib or abemaciclib

Key Exclusion

  • Prior exposure to CDK4/6 inhibitor
  • Concurrent hormone replacement therapy
  • Multicentric, multifocal, or synchronous contralateral breast cancer
  • Distant metastases or stage IV disease
  • Concurrent invasive malignancy or prior invasive malignancy within 5 years
  • Severe uncontrolled medical conditions limiting life expectancy to ≤5 years
  • Hypersensitivity to ribociclib or abemaciclib
  • Investigational product use within 30 days or 5 half-lives

NCT07276880

Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer Genomic-based

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 52-year-old woman with newly diagnosed node-positive triple-negative breast cancer, ECOG performance status 0, no prior breast cancer or chest radiation, and no active infections.

Phase N/A

Interventions

  • Radiation: High dose neoadjuvant boost
    Summary: Extra radiation treatments targeted at the tumor bed to shrink triple-negative breast cancer tumors before surgery, delivering localized radiation to reduce tumor burden and improve surgical outcomes (NCI Thesaurus, Web Search).
  • Radiation: low dose neoadjuvant boost
    Summary: Lower dose radiation treatments targeted at the tumor bed before surgery to target residual tumor cells and reduce recurrence in breast cancer, still under investigation (NCI Thesaurus, Web Search).
  • Biological: Neoadjuvant Pembrolizumab
    Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor to enhance T-cell-mediated immune responses against tumor cells, FDA-approved for multiple cancers including use in triple-negative breast cancer before surgery (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • ECOG or Karnofsky Performance Status of 0 or 1
  • Written informed consent and HIPAA authorization
  • Node-positive triple negative breast cancer

Key Exclusion

  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding
  • Prior ipsilateral invasive breast, chest wall or thoracic radiotherapy
  • Prior ipsilateral invasive breast cancer
  • Contralateral breast cancer
  • Additional invasive malignancy progressing or requiring active treatment in last 5 years

NCT07460752

MC250301, OptiOFS: A Randomized Phase II Trial of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Breast Cancer

Organization/Sponsor: Mayo Clinic


Example patient: A 42-year-old premenopausal woman with stage II ER-positive breast cancer in remission after surgery and radiation, currently on goserelin and an aromatase inhibitor for 8 months with suppressed estradiol levels.

Phase II

Interventions

  • Procedure: Questionnaire Administration
    Summary: Questionnaire administration collects patient self-reported outcomes to assess quality of life and psychological and physical impacts of treatment in breast cancer patients (NCI Thesaurus, Web Search).
  • Drug: Goserelin Acetate
    Summary: Goserelin acetate is a GnRH receptor agonist that suppresses gonadotropin secretion, reducing estradiol in females and testosterone in males, used for ovarian function suppression in hormone-positive breast cancer (FDA label, NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Biospecimen collection gathers blood and tissue samples to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies in breast cancer research (NCI Thesaurus, Web Search).

Key Inclusion

  • Age 18-50 years
  • Histologically or cytologically confirmed hormone positive breast cancer stage I-III (ER IHC >1%)
  • Completed curative intent therapy and clinically in remission
  • Currently receiving ovarian function suppression with goserelin monthly for at least 6 months
  • On aromatase inhibitor or tamoxifen with plan to continue OFS for at least 12 months
  • ECOG performance status 0, 1, or 2
  • Negative serum pregnancy test within 14 days and negative urine pregnancy test within 7 days
  • Estradiol E2 ≤20 pg/mL after cycle 6 with no back-to-back E2 >10 pg/mL

Key Exclusion

  • Chemotherapy within 6 months prior to registration
  • Receiving estrogen or progestin containing medications including topical estrogens
  • Planning to discontinue medical OFS in the next 12 months

NCT07488676

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 58-year-old woman with ER+/PR+/HER2- metastatic breast cancer expressing CLDN18.2, ECOG 1, who progressed after two prior chemotherapy regimens and has measurable lung metastases.

Phase 1, Phase 2

Interventions

  • Drug: ASP546C
    Summary: ASP546C is an antibody-drug conjugate targeting CLDN18.2-positive solid tumors that delivers cytotoxic agents directly to cancer cells expressing CLDN18.2. Source: Web Search Summary.

Key Inclusion

  • Histologically confirmed gastroesophageal, pancreatic, or pan-tumor adenocarcinoma including breast cancer subtypes
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease within 28 days
  • Received at least 1 prior line of therapy for advanced/metastatic disease
  • ECOG performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3) or evaluable disease (Cohort 4)
  • Adequate laboratory parameters within 14 days prior to first dose

Key Exclusion

  • Non-adenocarcinoma or mixed histology (Cohorts 1-3)
  • More than 2 prior lines of therapy for advanced disease (Cohorts 1-3)
  • Symptomatic untreated brain metastases or meningeal carcinomatosis
  • Prior CLDN18.2 antibody-drug conjugate treatment
  • Active autoimmune disease requiring high-dose systemic steroids
  • Significant cardiovascular disease or QTc >470 msec
  • Unresolved toxicity >grade 1 from prior anticancer therapy except alopecia
  • HER2 positive status (Cohorts 1-2 gastroesophageal only)

NCT07424547

Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Organization/Sponsor: Conjupro Biotherapeutics, Inc.


Example patient: A 52-year-old woman with metastatic breast cancer progressing after standard chemotherapy, ECOG status 1, with measurable lung metastases, LVEF 55%, no cardiac history, and no prior B7-H3 therapy.

Phase I

Interventions

  • Drug: SYS6043
    Summary: SYS6043 is an antibody-drug conjugate targeting B7-H3, a protein expressed in certain advanced tumors, delivering a cytotoxic payload to cancer cells expressing B7-H3 for treatment of advanced or metastatic solid tumors including breast cancer (Source: Web Search).

Key Inclusion

  • Aged ≥18 years old
  • Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology
  • Disease recurrence or progression during or after standard of care
  • At least one measurable lesion per RECIST V1.1
  • Life expectancy ≥3 months
  • ECOG performance status 0-1
  • LVEF ≥50% by ECHO or MUGA

Key Exclusion

  • Prior B7-H3 targeted therapy
  • Previously received topoisomerase inhibitor antibody-drug conjugate
  • Symptomatic congestive heart failure (NYHA Class II-IV) or severe arrhythmia
  • Myocardial infarction or unstable angina within 6 months
  • Mean QTcF >470 ms
  • History of interstitial lung disease or non-infectious pneumonia
  • Active clinically significant bacterial, fungal, or viral infection
  • Spinal cord compression or clinically active brain metastasis

NCT07524855

A Phase 1 Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)

Organization/Sponsor: Halda Therapeutics OpCo, Inc.


Example patient: A 62-year-old postmenopausal woman with ER-positive/HER2-negative metastatic breast cancer, ECOG 1, previously treated with letrozole, palbociclib, and one chemotherapy regimen, now with progressive disease on fulvestrant.

Phase 1

Interventions

  • Drug: HLD-0117
    Summary: HLD-0117 is an experimental RIPTAC (RIPTate and Kill Cancer) agent targeting ER-positive breast cancer through a novel mechanism in ER-driven, ER co-driven, and ER-independent metastatic disease. Source: Web Search.

Key Inclusion

  • Female, ≥18 years old
  • Histologically confirmed metastatic or locally advanced breast cancer
  • Postmenopausal or ovarian suppression with GnRH agonist
  • Prior endocrine therapy and CDK4/6 inhibitor
  • No more than two prior cytotoxic regimens in metastatic setting
  • ER-positive and HER2-negative
  • ECOG performance status 0-1
  • Measurable disease per RECIST v1.1

Key Exclusion

  • Inflammatory breast cancer or known brain metastases
  • Recent major bleeding or uncontrolled bleeding disorder
  • Corticosteroid use >10 mg/day prednisone equivalent
  • Anticancer therapy within 14 days (28 days for fulvestrant)
  • Significant cardiovascular disease within 6 months
  • Active or uncontrolled infection
  • Major surgery within 28 days
  • Pregnancy or breastfeeding

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+/HER2-low metastatic breast cancer (IHC 2+, FISH negative) with liver 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 delivers a cytotoxic payload to cancer cells, showing effectiveness in HER2-low and T-DM1-resistant breast cancers (Summary of Web Search).
  • Drug: Amiloride
    Summary: Amiloride targets sodium channels and induces apoptosis in breast cancer cells; its derivatives kill cancer cells independently of tumor type (Summary of Web Search).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Summary of Web Search).
  • Diagnostic Test: Computed Tomography (CT)
    Summary: CT and PET/CT scans detect breast cancer spread, identify metastases, and assess treatment response, particularly useful in advanced stages (Summary of Web Search).

Key Inclusion

  • Age 18 years or greater with ECOG score 0-2
  • HER2-low (IHC 1+ or 2+ without gene amplification) locally advanced unresectable or metastatic breast cancer
  • At least one measurable lesion per RECIST v1.1
  • At least one prior line of chemotherapy or ADC therapy for locally advanced or metastatic disease
  • Left ventricular ejection fraction ≥50% or institutional lower limit
  • Adequate organ function including hemoglobin ≥8.0 g/dL, ANC ≥1.0x10^9/L, platelets ≥100,000x10^9/L
  • Stable treated brain metastases allowed if corticosteroids ≤2 mg dexamethasone daily
  • Recovery from prior therapy toxicities to ≤grade 1 except alopecia and neuropathy

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
  • Congestive heart failure, unstable angina, myocardial infarction within 6 months, or QTcF >470 msec (females) or >450 msec (males)
  • Diagnosis of leptomeningeal carcinomatosis
  • Investigational or commercial anti-cancer therapy within 14 days before first dose
  • Radiotherapy outside brain <7 days prior to first dose
  • Pregnancy or breastfeeding

NCT07465172

A Multi-centre, Prospective Cohort Study to Explore the Relationship Between Changes in GDF-15 Levels and Treatment-related Adverse Events During T-DXd Treatment in Breast Cancer Patients. Genomic-based

Organization/Sponsor: Breast Cancer Trials, Australia and New Zealand


Example patient: A 52-year-old woman with metastatic HER2-positive breast cancer scheduled to begin T-DXd therapy, with normal oral intake and no active cachexia.

Phase N/A

Interventions

  • Procedure: Blood collection for GDF-15
    Summary: Blood collection procedure to measure GDF-15 biomarker levels for monitoring treatment-related adverse events during T-DXd therapy (source: NCI Thesaurus).

Key Inclusion

  • Aged 18 years or older
  • Histologically confirmed metastatic or advanced unresectable HER2-positive or HER2-low breast cancer
  • Planned to start treatment with T-DXd
  • Life expectancy of at least 4 months

Key Exclusion

  • Current active reversible causes of decreased food intake
  • Receiving tube feedings or parenteral nutrition at enrollment
  • Ongoing cachexia attributable to other reasons unrelated to cancer or cancer treatment
  • Current adherence to calorie-restricted diet with intention of weight loss

NCT07426913

Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 52-year-old English-speaking woman with newly diagnosed stage II HER2-positive breast cancer currently receiving Trastuzumab therapy without any prior breast cancer history.

Phase N/A

Interventions

  • Behavioral: Cardiovascular Health Education and Gaming through Virtual Reality
    Summary: Immersive computer-generated educational experience delivered via headset with interactive sensors to teach cardiovascular health concepts, sourced from NCI Thesaurus.

Key Inclusion

  • 18 years of age or older
  • Able to speak and read in English
  • Actively receiving Trastuzumab or anthracycline-based treatment
  • Diagnosed with stages 0-III Breast Cancer

Key Exclusion

  • History of prior Breast Cancer diagnosis
  • Not their first breast cancer diagnosis

NCT07402473

EUREKA Study: Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer Using ctDNA and HARPS Biomarker Assay Genomic-based

Organization/Sponsor: Rutgers, The State University of New Jersey


Example patient: A 52-year-old woman with a 3.5cm HER2-positive, ER-positive invasive ductal carcinoma with one palpable axillary lymph node, LVEF 58%, no prior chemotherapy, adequate organ function, and available tumor tissue for HARPS biomarker testing.

Phase 2

Interventions

  • chemotherapy: Carboplatin
    Summary: Platinum-based chemotherapy that forms DNA cross-links to inhibit cancer cell replication and induce apoptosis, used in breast cancer treatment with similar efficacy to cisplatin but improved tolerability (FDA label, NCI Thesaurus).
  • chemotherapy: Docetaxel
    Summary: Taxane chemotherapy that stabilizes microtubules to prevent cancer cell division, used in HER2-positive breast cancer often in combination regimens (Web Search).
  • biologic: Pertuzumab
    Summary: Monoclonal antibody targeting HER2 receptor to block dimerization and inhibit cancer cell growth, used in HER2-positive breast cancer typically combined with trastuzumab (Web Search).
  • biologic: Trastuzumab
    Summary: Monoclonal antibody that binds HER2 protein to block growth signals and induce immune-mediated destruction of HER2-positive breast cancer cells (Web Search).

Key Inclusion

  • Tumor size greater than 2cm or lymph node positive (cT2-T3 N0-2)
  • HER2 positive by IHC 3+ or IHC 2+ with FISH positive
  • Known ER and PR status
  • Adequate tumor for HARPS testing
  • ctDNA collection prior to treatment
  • LVEF greater than 50%
  • No prior anthracycline-based chemotherapy
  • Adequate bone marrow, hepatic, and renal function

Key Exclusion

  • Previous chemotherapy, anti-HER2 therapy, radiation, or endocrine therapy for invasive breast cancer
  • cT4 or cN3 tumors
  • Evidence of metastatic disease
  • Bilateral breast cancer
  • LVEF below 50%
  • Pre-existing sensory neuropathy greater than grade 1
  • Clinically significant cardiac disease or MI within 6 months
  • Active liver disease

NCT07109817

Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer (DETOXp)

Organization/Sponsor: Montefiore Medical Center


Example patient: A 52-year-old woman with newly diagnosed stage II HER2-positive breast cancer, ECOG 1, no prior neuropathy or chemotherapy, scheduled for 16 weeks of neoadjuvant paclitaxel plus trastuzumab and pertuzumab.

Phase N/A

Interventions

  • Drug: Desloratadine
    Summary: A selective H1-antihistamine receptor antagonist that blocks histamine-mediated responses and is being studied for preventing taxane-induced peripheral neuropathy in breast cancer patients. FDA-approved for allergic rhinitis and urticaria; investigational for neuroprotection during chemotherapy (FDA label, NCI Thesaurus).
  • Drug: Placebo
    Summary: An inactive compound identical in appearance to desloratadine, used as a control to distinguish drug action from placebo effects in this trial (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed breast cancer, stage I-III (AJCC 8th edition)
  • Planned taxane-based regimen for at least 12 weeks (adjuvant or neoadjuvant)
  • Age ≥18 years
  • ECOG performance status ≤2
  • Adequate organ and marrow function (ANC ≥1,000/mcL, platelets ≥100,000/mcL)
  • No prior taxane or platinum therapy
  • Negative pregnancy test for women of childbearing potential

Key Exclusion

  • Prior diagnosis of peripheral neuropathy
  • Prior chemotherapy for current breast cancer diagnosis
  • Concurrent use of antihistamines during or 2 days prior to study
  • History of allergic reactions to desloratadine or similar compounds
  • Pregnant or breastfeeding women
  • Taking probiotics, chronic laxatives, or enema
  • Antibiotic use within 4 weeks of registration

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 invasive disease in axillary nodes, ECOG 1, and normal cardiac function.

Phase 1

Interventions

  • Biological: HER2 Vaccine
    Summary: The HER2 vaccine targets the HER2 protein to activate the immune system against HER2-positive breast cancer, emulsified in ISA 720 adjuvant to enhance immune response. Source: Summary of Web Search.

Key Inclusion

  • Age ≥18 years
  • 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 or TDM-1
  • 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
  • History of anaphylactic responses to vaccines
  • HIV, HBV, or HCV infection (except seropositivity from vaccination)

NCT07540572

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer

Organization/Sponsor: IDEAYA Biosciences


Example patient: A 58-year-old postmenopausal woman with metastatic ER-positive, HER2-negative breast cancer who progressed after treatment with letrozole and palbociclib, with ECOG status 1 and adequate organ function.

Phase 1

Interventions

  • Drug: IDE574
    Summary: IDE574 is a dual inhibitor of KAT6/7 enzymes that blocks specific pathways to inhibit cancer growth in breast cancer and other solid tumors, currently in Phase 1 trials (Source: Web Search).
  • Drug: Fulvestrant injection
    Summary: Fulvestrant is a hormonal therapy that degrades estrogen receptors to block estrogen effects in hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, administered via injection (Source: Web Search).

Key Inclusion

  • Advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, or MSS colorectal adenocarcinoma
  • Progressed after at least one line of standard therapy or intolerant to effective therapies
  • ER+, HER2- breast cancer progressed after endocrine therapy and CDK4/6 inhibitor
  • Female participants willing to undergo medically induced menopause (Parts 2A and 2B)
  • ECOG performance status ≤1
  • Adequate bone marrow, renal and liver function
  • Life expectancy >3 months
  • Archival tissue sample available for testing

Key Exclusion

  • Known symptomatic brain metastases or leptomeningeal metastasis
  • Known primary CNS malignancy or other malignancies within 2 years
  • Impairment of GI function that may alter IDE574 absorption
  • Active liver or biliary disease
  • Active uncontrolled bacterial, fungal, or viral infection
  • Clinically significant cardiac abnormalities or blood clotting events within 6 months
  • Prior irradiation to >25% of bone marrow
  • Hypersensitivity to IDE574, fulvestrant, or their excipients