Clinical Trials for Breast Cancer

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling

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 brain metastases whose tumors have abnormally active HER2 signaling (per CELsignia test), including both ER-positive and triple-negative subtypes, and treats them with the investigational HER2 pathway inhibitor neratinib plus capecitabine. Eligible patients must have appropriate prior treatment and be able to undergo biopsy and systemic therapy.

ClinicalTrials.gov ID: NCT04965064

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 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 ER-positive, HER2-negative breast cancer and active, measurable brain metastases who have progressed on prior endocrine therapy (excluding prior abemaciclib in the metastatic setting), testing oral elacestrant (a selective estrogen receptor degrader) in combination with abemaciclib (a CDK4/6 inhibitor). The study excludes patients with leptomeningeal disease, imminent visceral crisis, or prior metastatic abemaciclib exposure.

ClinicalTrials.gov ID: NCT05386108

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

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 breast cancer (ER+/HER2- or any HER2+) who have had at least 6 months of response to systemic therapy and now show a solitary progressing metastasis; patients will receive SBRT to the progressive lesion while continuing their current systemic therapy. SBRT is delivered to the single progressing site with the intent to prolong systemic disease control.

ClinicalTrials.gov ID: NCT05534438

Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)

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 various solid tumors (including breast, gynecologic, head and neck cancers, and sarcomas) who have oligo-progressive disease (≤5 progressing metastatic lesions) despite ongoing benefit from systemic therapy; patients continue their current systemic treatment and receive locally ablative therapy (via stereotactic ablative radiotherapy or image-guided ablation) to all progressing sites.

ClinicalTrials.gov ID: NCT06103669

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) 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 hormone receptor-positive, HER2-negative breast cancer who require radiation for bone metastasis, including those with prior CDK4/6 inhibitor exposure. Patients receive focal radiation therapy combined with abemaciclib, an oral CDK4/6 inhibitor that blocks cell cycle progression, with abemaciclib dose escalation to determine safety and tolerability.

ClinicalTrials.gov ID: NCT06678269

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation

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 pancreatic, prostate, breast, or ovarian cancers harboring pathogenic or likely pathogenic germline BRCA2 and/or PALB2 mutations (with an exploratory cohort for other HRD-associated ovarian/fallopian/peritoneal cancers), treating them with intravenous CX-5461, a G-quadruplex DNA stabilizer that selectively targets homologous recombination–deficient tumor cells. Prior PARP inhibitor and systemic therapies are allowed, and patients must have measurable disease and ECOG ≤2.

ClinicalTrials.gov ID: NCT04890613

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW 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 metastatic, hormone receptor positive (HR+)/HER2-low breast cancer who are endocrine-refractory and have progressed after prior trastuzumab deruxtecan (T-DXd); all participants receive sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 and delivering SN-38, to assess its efficacy in this setting.

ClinicalTrials.gov ID: NCT06263543

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-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 unresectable, ER-positive, HER2-negative breast cancer (no prior abemaciclib) to receive abemaciclib (a selective CDK4/6 inhibitor) plus standard endocrine therapy, with pre-treatment functional imaging to assess predictive biomarkers of response. Both men and premenopausal women are eligible with appropriate endocrine management.

ClinicalTrials.gov ID: NCT06179303

This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable 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, PIK3CA-mutant locally advanced unresectable or metastatic breast cancer (HR+ or HR-, ECOG 0-1) previously treated with at least two HER2-directed therapies, including those with stable or treated CNS metastases. Participants receive tucatinib (HER2-selective tyrosine kinase inhibitor) plus alpelisib (PIK3CA-selective PI3K inhibitor), with the addition of fulvestrant for HR+ disease.

ClinicalTrials.gov ID: NCT05230810

Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive 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: Adults with HER2-positive breast cancer and newly diagnosed brain metastases (1-10 lesions, each ≤3 cm) receive stereotactic radiosurgery combined with tucatinib (a selective HER2-directed tyrosine kinase inhibitor), trastuzumab, and capecitabine. Patients with leptomeningeal disease or significant cardiac history are excluded.

ClinicalTrials.gov ID: NCT05553522