Clinical Trials for Breast Cancer

Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced Breast Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Eligible patients are adult women with HER2-negative, germline BRCA-mutated advanced or metastatic breast cancer previously treated with a PARP inhibitor, randomized to olaparib plus cediranib (a VEGFR 1/2/3 tyrosine kinase inhibitor targeting angiogenesis) or olaparib plus ceralasertib (an ATR kinase inhibitor targeting the DNA damage response pathway). Both regimens are oral and require patients to have measurable disease and good performance status.

ClinicalTrials.gov ID: NCT04090567

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls patients with locally advanced or metastatic breast cancer or gastric/gastroesophageal junction adenocarcinoma—either HER2-low or HER2-positive—who have progressed on or are intolerant to standard therapy, and treats them with the combination of disitamab vedotin (an anti-HER2 antibody-drug conjugate delivering MMAE) and tucatinib (a HER2 tyrosine kinase inhibitor). Four cohorts are studied based on tumor type and HER2 expression.

ClinicalTrials.gov ID: NCT06157892

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls adults with recurrent or metastatic solid tumors—including endometrial, head and neck, pancreatic, colorectal, hepatocellular, gastric, urothelial, ovarian, cervical, biliary tract, certain subtypes of breast cancer, and cutaneous melanoma—whose disease has progressed after standard therapy and who have measurable, biopsiable disease. All patients receive ifinatamab deruxtecan, an investigational B7-H3-directed antibody-drug conjugate delivering a topoisomerase I inhibitor, administered intravenously every three weeks.

ClinicalTrials.gov ID: NCT06330064

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with solid tumors and high-risk brain metastases (e.g., melanoma refractory to immunotherapy, GI primaries, HER2+ breast cancer, cystic or large lesions, or local recurrence after prior brain radiation) are randomized to stereotactic radiation with or without intravenous AGuIX gadolinium-based nanoparticles, which act as tumor-targeted radiosensitizers and MRI contrast agents.

ClinicalTrials.gov ID: NCT04899908

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with HR+/HER2- locally advanced or metastatic breast cancer who have progressed after 1–2 prior lines of systemic therapy (including at least one endocrine therapy, with or without prior CDK4/6 inhibitor or chemotherapy), and in phase III requires PIK3CA/AKT1/PTEN pathway alterations. Patients are randomized to receive fulvestrant with either afuresertib, an oral pan-AKT inhibitor targeting the PI3K/AKT pathway, or placebo.

ClinicalTrials.gov ID: NCT04851613

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with recurrent metastatic breast cancer of any subtype who have progressed after all standard therapies, including those with stable brain metastases, to receive an HLA-matched, off-the-shelf allogeneic cellular immunotherapy (Bria-OTS, designed to induce anti-tumor immune responses), given alone or in combination with cyclophosphamide, peginterferon alpha-2a, and the PD-1 inhibitor tislelizumab.

ClinicalTrials.gov ID: NCT06471673

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in PD-L1 Negative TNBC

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Eligible patients are adults with metastatic triple negative breast cancer who have progressed on one to two prior systemic therapies and have not received prior checkpoint inhibitors in the metastatic setting; the trial evaluates oral ivermectin (an antiparasitic agent with potential anticancer effects) in combination with either balstilimab (an investigational anti-PD-1 antibody) or pembrolizumab, with a focus on PD-L1 negative disease in the phase 2 cohort.

ClinicalTrials.gov ID: NCT05318469

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Eligible patients are adults with metastatic triple-negative breast cancer and measurable brain metastases who can undergo stereotactic radiosurgery; treatment consists of SRS followed by sacituzumab govitecan (an anti-Trop-2 antibody-drug conjugate) and zimberelimab (a PD-1 inhibitor immunotherapy). Prior taxane/anthracycline or SRS/FSRT therapy (if new lesions) is allowed; key exclusions are leptomeningeal disease, significant comorbidities, active autoimmune disease requiring immunosuppression, and prior topoisomerase I inhibitor use for brain metastases.

ClinicalTrials.gov ID: NCT06238921

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with metastatic or unresectable, recurrent triple negative breast cancer (TNBC) who have had up to two prior lines of chemotherapy and limited prior immunotherapy, randomizing them to receive avelumab (PD-L1 inhibitor) combined with either liposomal doxorubicin, liposomal doxorubicin plus binimetinib (MEK inhibitor), or sacituzumab govitecan (TROP2-directed antibody-drug conjugate). Patients must have measurable disease, ECOG 0-1, and be biopsy-amenable.

ClinicalTrials.gov ID: NCT03971409