Clinical Trials for Breast Cancer

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

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

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 locally advanced unresectable or metastatic triple-negative breast cancer (TNBC), ECOG 0-1, and no more than 3 prior lines of chemotherapy, treated with a regimen of trilaciclib (a CDK4/6 inhibitor given to protect bone marrow during chemotherapy), pembrolizumab (PD-1 inhibitor), gemcitabine, and carboplatin. The study excludes those with active CNS metastases or recent systemic anti-cancer therapy.

ClinicalTrials.gov ID: NCT06027268

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance

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: Adult patients with HER2-positive metastatic breast, lung, esophagogastric, or colorectal cancer with brain metastases requiring surgical resection (including those with prior or no prior tucatinib exposure) receive a 4-day pre-operative course of tucatinib, a selective HER2 tyrosine kinase inhibitor with CNS activity. Post-operative therapy is not dictated by the study.

ClinicalTrials.gov ID: NCT05892068

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

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 postmenopausal women with ER+/HER2- metastatic or recurrent breast cancer who have progressed after CDK4/6 inhibitor therapy, assigning patients to combinations of fulvestrant with targeted agents (neratinib for ERBB2 mutations, alpelisib for PIK3CA mutations, everolimus for AKT1/MTOR/PTEN alterations, or abemaciclib for others) based on tumor genetic profiling. Targeted agents address specific molecular drivers: neratinib (pan-HER TKI), alpelisib (PI3K alpha inhibitor), everolimus (mTOR inhibitor), and abemaciclib (CDK4/6 inhibitor).

ClinicalTrials.gov ID: NCT05933395

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or Metastatic 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 HER2-positive unresectable locally recurrent or metastatic breast cancer (ECOG 0-1) who have not received prior chemotherapy or HER2-targeted therapy for advanced disease, and tests intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) as induction, followed by maintenance therapy with subcutaneous fixed-dose pertuzumab and trastuzumab (PHESGO).

ClinicalTrials.gov ID: NCT06172127

Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic 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 unresectable triple negative breast cancer who have progressed on prior chemo-immunotherapy with pembrolizumab, and evaluates the combination of oral propranolol (a non-selective beta-adrenergic blocker thought to reduce stress-mediated immunosuppression) plus pembrolizumab to assess whether propranolol can re-sensitize tumors to checkpoint inhibition. All patients must be ECOG 0-1 and willing to undergo serial biopsies.

ClinicalTrials.gov ID: NCT05741164

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced 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 breast cancer strictly classified as HER2-IHC 0 (never HER2-positive or HER2-low), who have received 1–2 prior lines of systemic therapy and no prior anti-HER2 therapy, to evaluate trastuzumab deruxtecan (T-DXd), a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, given IV every 3 weeks.

ClinicalTrials.gov ID: NCT06750484

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label 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 metastatic, treatment-naïve, estrogen receptor-positive, HER2-negative breast cancer to receive first-line endocrine therapy plus a CDK4/6 inhibitor, with randomization at rising ctDNA (without clinical progression) to either switch to alternative endocrine and targeted therapies or continue initial treatment. The study investigates whether therapy change based on early ctDNA detection improves disease control compared to standard progression-based switching.

ClinicalTrials.gov ID: NCT05826964

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer

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 HER2-positive breast cancer who have progressed on trastuzumab and received up to three prior chemotherapy lines, and tests sequential treatment with HER2-pulsed dendritic cell vaccine, trastuzumab, and pepinemab (a SEMA4D inhibitor) followed by adoptive transfer of ex vivo expanded, HER2-specific CD4+ Th1 cells. Booster vaccines and continued trastuzumab/pepinemab maintenance follow adoptive cell infusion.

ClinicalTrials.gov ID: NCT05378464