Clinical Trials for Breast Cancer

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

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.

HealthScout AI summary: This trial enrolls adults with advanced sarcoma, prostate, breast, ovarian, or pancreatic cancers who have progressed after prior systemic therapy, assigning individualized regimens—including targeted agents like CDK4/6 inhibitors (abemaciclib), PARP inhibitors (olaparib), EGFR inhibitors (gefitinib, osimertinib), endocrine therapies, and chemotherapeutics—based on serial molecular profiling and multidisciplinary tumor board review. Patients may switch treatments upon progression or toxicity according to ongoing molecular and proteomic data.

ClinicalTrials.gov ID: NCT06630325

A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

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 hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer who are candidates for fulvestrant and a CDK4/6 inhibitor, and randomizes them to receive either standard therapy (CDK4/6 inhibitor plus fulvestrant) or the addition of capivasertib, an oral AKT inhibitor targeting the PI3K/AKT pathway. Prior use of AKT/PI3K/mTOR inhibitors or CDK4/6 inhibitors in the advanced/metastatic setting are excluded.

ClinicalTrials.gov ID: NCT04862663

Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System 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.

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 progressive, measurable CNS metastases from solid tumors and CDK pathway alterations (Cohort 1) receive palbociclib, a selective CDK4/6 inhibitor, while patients with breast cancer brain metastases (Cohort 2) receive palbociclib plus pembrolizumab, an anti–PD-1 immunotherapy. Prior CNS-directed therapy is allowed; key exclusions include prior CDK4/6 inhibitor use, leptomeningeal disease (Cohort 1), and active autoimmune disease (Cohort 2).

ClinicalTrials.gov ID: NCT02896335

A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer

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.

HealthScout AI summary: This trial enrolls adult women with hormone receptor-positive, HER2-negative metastatic breast cancer who have progressed after prior endocrine therapy, using a sequential regimen of standard chemotherapy (cyclophosphamide, docetaxel, GM-CSF), followed by either sacituzumab govitecan (Trop-2 antibody-drug conjugate) or trastuzumab deruxtecan (HER2 antibody-drug conjugate), then capecitabine, and finally fulvestrant plus a CDK4/6 inhibitor. Prior fulvestrant or active CNS metastases are exclusion criteria.

ClinicalTrials.gov ID: NCT06409390

A Phase 2 Study of Palliative Radiation in Combination with Pembrolizumab in Subjects with Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

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 adult women with unresectable metastatic stage IV breast cancer who have progressed on at least two prior lines of standard therapy, including appropriate agents for their cancer subtype. Participants receive palliative stereotactic body radiation therapy (SBRT) combined with pembrolizumab, a PD-1 inhibitor immunotherapy.

ClinicalTrials.gov ID: NCT04990921

Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Immunotherapy Combinations for the Augmentation of Immune Responses

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 adult women with metastatic triple-negative or ER-positive/HER2-negative breast cancer, including those who have progressed after prior immune checkpoint inhibitor therapy or are PD-L1 negative, to evaluate pembrolizumab (anti-PD-1 antibody) plus stereotactic ablative radiotherapy, with or without olaparib (PARP inhibitor), for systemic immune and tumor response.

ClinicalTrials.gov ID: NCT04683679

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant 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.

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 metastatic or unresectable, hormone receptor positive, HER2 negative, PIK3CA-mutant breast cancer who have progressed on 1–2 prior lines of endocrine therapy (with/without CDK4/6 inhibitors) receive alpelisib, a selective PI3K alpha inhibitor, daily in combination with investigator’s choice of continued endocrine therapy (aromatase inhibitor or fulvestrant). Prior chemotherapy or prior PI3K/mTOR/AKT inhibitors for metastatic disease are not allowed.

ClinicalTrials.gov ID: NCT04762979

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: This trial enrolls adults with advanced HRR-mutated solid tumors—including previously treated breast, ovarian, fallopian tube, primary peritoneal, castration-resistant prostate, or pancreatic cancers—who may have had limited prior PARP inhibitor exposure and CNS metastases if stable. Patients receive EIK1004 (IMP1707), a highly selective CNS-penetrant PARP1 inhibitor, as oral monotherapy.

ClinicalTrials.gov ID: NCT06907043

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

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: Eligible patients have metastatic breast cancer with at least two untreated brain metastases (≥5 mm), are ECOG 0-1, and may continue concurrent hormonal or anti-HER2 treatment; participants receive stereotactic radiosurgery (SRS) to one lesion followed by pembrolizumab, an anti-PD-1 monoclonal antibody immunotherapy, to assess responses in non-irradiated brain lesions and systemically. Prior SRS is permitted if new lesions are targeted, and key exclusions include active autoimmune disease and recent complete CNS resection.

ClinicalTrials.gov ID: NCT03449238

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer

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.

HealthScout AI summary: This trial enrolls adults with metastatic, unresectable colorectal cancer or CEA-positive metastatic breast cancer who have failed standard therapy, testing the combination of stereotactic body radiation therapy (SBRT) and M5A-IL2 immunocytokine—a novel agent that targets CEA-expressing tumors by delivering interleukin-2 directly to the tumor microenvironment. Patients must have 1-5 metastatic lesions amenable to SBRT and good performance status; CNS metastases and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT06130826