Clinical Trials for Breast Cancer

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors

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 HER2-positive advanced solid tumors, including breast cancer patients with or without brain metastases who have progressed on prior anti-HER2 therapy, to receive the investigational brain-penetrant HER2-selective tyrosine kinase inhibitor ZN-A-1041 as monotherapy or in combination with standard anti-HER2 agents such as T-DM1, T-DXd, PHESGO, or Herceptin plus Perjeta. ZN-A-1041 is an oral agent designed to overcome blood-brain barrier limitations and is being evaluated for safety and preliminary efficacy in this setting.

ClinicalTrials.gov ID: NCT05593094

A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers

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 adults with locally recurrent, unresectable or metastatic triple negative or ER-low breast cancer (≤9% ER, ECOG 0-1, ≤1 prior metastatic chemo) are randomized to receive standard of care chemotherapy with or without tocilizumab, an anti-IL-6 receptor monoclonal antibody, with cohorts stratified by race. Prior immune checkpoint inhibitor therapy is allowed, but patients with active CNS disease, known HER2+ tumors, or prior tocilizumab are excluded.

ClinicalTrials.gov ID: NCT05846789

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

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 advanced or metastatic solid tumors—including breast, ovarian, prostate, pancreatic (HRR-mutated), IDH1/2-mutant glioma, and other selected solid cancers—who have progressive disease and good performance status, testing the selective PARP1 inhibitor AZD9574 as monotherapy or in combination with temozolomide, trastuzumab deruxtecan, or datopotamab deruxtecan. Eligibility may require specific genetic or molecular features depending on tumor type and study module.

ClinicalTrials.gov ID: NCT05417594

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases

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 HER2-negative metastatic breast cancer and measurable brain metastases (ECOG 0-1, ≤3 prior chemo regimens) to receive utidelone, a microtubule-stabilizing epothilone analog, alone or with capecitabine. Key exclusions include prior capecitabine failure, leptomeningeal disease, or lesions needing urgent intervention.

ClinicalTrials.gov ID: NCT06764940

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

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 advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329

Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

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 metastatic, hormone receptor-positive, HER2-negative, E-cadherin–negative invasive lobular carcinoma previously treated with endocrine therapy plus a CDK4/6 inhibitor, testing repotrectinib (a next-generation tyrosine kinase inhibitor of ROS1/TRK/ALK) with or without fulvestrant. Cohorts are based on fulvestrant exposure: fulvestrant-naïve patients receive combination therapy, while those previously treated with fulvestrant receive repotrectinib alone.

ClinicalTrials.gov ID: NCT06408168

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?

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 metastatic or locally advanced, inoperable triple negative breast cancer who have at least one lesion suitable for cryoablation and are eligible for pembrolizumab, a PD-1 inhibitor. It compares pembrolizumab alone to pembrolizumab combined with cryoablation to assess whether the addition of local ablation enhances immune response.

ClinicalTrials.gov ID: NCT06246968

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

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 unresectable or metastatic HER2-positive breast cancer who have progressed on or are intolerant to prior trastuzumab deruxtecan, randomizing them to zanidatamab (a bispecific anti-HER2 antibody) plus physician’s choice chemotherapy versus trastuzumab plus physician’s choice chemotherapy. Patients may have stable or treated CNS metastases, and chemotherapy options include eribulin, vinorelbine, gemcitabine, or capecitabine.

ClinicalTrials.gov ID: NCT06435429

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER

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 unresectable or metastatic AR-positive triple-negative or ER-low breast cancer (≥10% AR by IHC), randomized to receive either enzalutamide (androgen receptor inhibitor), enzalutamide plus mifepristone (glucocorticoid receptor antagonist), or standard single-agent chemotherapy. Patients may have received up to two prior metastatic chemotherapy lines and may cross over to the investigational arm at progression if eligible.

ClinicalTrials.gov ID: NCT06099769

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

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 women with metastatic, non–triple-negative breast cancer who have 1-3 extracranial oligoprogressive lesions despite ongoing benefit from current systemic therapy, treating these lesions with stereotactic body radiotherapy (SBRT) while patients remain on their existing systemic regimen. Eligible patients must have adequate performance status, no active CNS disease, and no more than three extracranial progressing sites.

ClinicalTrials.gov ID: NCT06055881