Clinical Trials for Breast Cancer

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic HER2-positive breast cancer who have progressed after trastuzumab deruxtecan (T-DXd), including those with stable brain metastases, to receive ARX788, an investigational HER2-targeted antibody–drug conjugate carrying a tubulin inhibitor payload, given every three weeks. Key exclusions include significant lung disease and uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT04829604

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.

HealthScout 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.

HealthScout 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

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic 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.

HealthScout AI summary: This trial enrolls adults with HER2-positive, estrogen receptor-positive, locally advanced or metastatic breast cancer (no prior systemic non-hormonal therapy in this setting) following induction with Phesgo plus taxane, and randomizes them to maintenance therapy with Phesgo alone or Phesgo plus giredestrant, an investigational oral selective estrogen receptor degrader (SERD) targeting ER signaling.

ClinicalTrials.gov ID: NCT05296798

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic 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.

HealthScout AI summary: This trial enrolls adult men and postmenopausal women with ER-positive, HER2-negative locally advanced or metastatic breast cancer that has progressed after at least two prior endocrine therapies and/or CDK4/6 inhibitor therapy, including those with up to three prior lines of chemotherapy. Patients receive oral AC699, a novel chimeric estrogen receptor degrader (ERα degrader), as monotherapy.

ClinicalTrials.gov ID: NCT05654532

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative 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.

HealthScout AI summary: This study enrolls adults with advanced or metastatic ER-positive, HER2-negative breast cancer (with limited prior systemic therapy) to receive OP-1250 (palazestrant), a complete estrogen receptor antagonist and degrader, in combination with either ribociclib (CDK4/6 inhibitor), alpelisib (PI3K inhibitor), or everolimus (mTOR inhibitor). Eligible patients must have measurable or evaluable disease and ECOG 0-1.

ClinicalTrials.gov ID: NCT05508906