Clinical Trials for Breast Cancer

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer 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.

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 metastatic breast cancer and up to 15 brain metastases (measurable by RANO-BM and eligible for SRS) to receive abemaciclib (a CDK4/6 inhibitor), endocrine therapy, and stereotactic radiosurgery. Patients must not have prior whole brain radiotherapy, leptomeningeal disease, or recent abemaciclib exposure.

ClinicalTrials.gov ID: NCT04923542

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail

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 metastatic breast cancer (triple-negative, HER2-positive, or hormone-refractory) and confirmed leptomeningeal metastasis, with or without brain metastases, to receive intravenous high-dose methotrexate, an antimetabolite chemotherapeutic with CNS activity. Patients must have good performance status and no recent chemotherapy, extensive brain irradiation, or prior methotrexate exposure.

ClinicalTrials.gov ID: NCT02422641

Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)

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 HR+, HER2-negative metastatic breast cancer and PI3K pathway alterations (PIK3CA, PTEN, AKT1) to receive triplet therapy with fulvestrant, a PI3K (alpelisib) or AKT (capivasertib) inhibitor, and evexomostat—a MetAP2 inhibitor with anti-angiogenic and metabolic effects—while assessing both cancer response and metabolic side effects such as hyperglycemia.

ClinicalTrials.gov ID: NCT05455619

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing 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: Adults with hormone receptor positive, HER2 negative metastatic breast cancer harboring an ESR1 mutation, previously treated with endocrine therapy and a CDK4/6 inhibitor, receive autologous dendritic cell vaccines targeting native and mutated ESR1 peptides (to induce specific anti-ESR1 immune responses) combined with oral elacestrant, a selective estrogen receptor degrader.

ClinicalTrials.gov ID: NCT06691035

A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis

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: Eligible patients are adults with metastatic or recurrent mesothelin-positive esophagogastric adenocarcinoma and peritoneal carcinomatosis who have progressed on prior systemic therapies. Participants receive intraperitoneal infusion of M28z1XXPD1DNR, an autologous CAR T-cell therapy targeting mesothelin with modifications to enhance activity and resist PD-1–mediated immune suppression.

ClinicalTrials.gov ID: NCT06623396

A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative 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 unresectable, locally advanced, or metastatic triple-negative breast cancer, including both previously treated and systemic therapy-naïve patients, to receive sacituzumab govitecan—a Trop-2–targeting antibody-drug conjugate linked to the topoisomerase I inhibitor SN-38—administered at an alternative dosing schedule.

ClinicalTrials.gov ID: NCT06926920

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical 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.

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 breast cancer harboring confirmed deleterious somatic (tumor-acquired, not germline) BRCA1 or BRCA2 mutations who have received prior appropriate therapy and have not previously received PARP inhibitors. Patients are treated with talazoparib, a PARP inhibitor targeting defective DNA repair in BRCA-mutant tumor cells.

ClinicalTrials.gov ID: NCT03990896

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

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 leptomeningeal disease from either triple-negative or HER2-positive breast cancer, using an intrathecal dendritic cell vaccine pulsed with HER2/HER3 peptides to stimulate an anti-tumor immune response in the CNS. Eligible patients must have an Ommaya reservoir or equivalent device for vaccine administration.

ClinicalTrials.gov ID: NCT05809752

Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative 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 or unresectable HER2-negative breast cancer (including HER2 low) and BRCA1/2 or PALB2 mutations (germline or somatic), who have received no more than two prior lines of chemotherapy for metastatic disease. Participants receive axatilimab, a CSF1R-targeting monoclonal antibody that modulates tumor-associated macrophages, in combination with the PARP inhibitor olaparib.

ClinicalTrials.gov ID: NCT06488378

CIMER: Combined Immunotherapies in Metastatic ER+ 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: This trial enrolls adults with metastatic hormone receptor positive, HER2 negative breast cancer (up to 5 measurable lesions), eligible for first-line endocrine therapy plus CDK4/6 inhibition, and randomizes them to standard letrozole and palbociclib with or without the addition of Stereotactic Body Radiation Therapy (SBRT) to all metastatic sites. Both women (pre- and postmenopausal) and men are eligible, with key exclusions including active autoimmune disease, immunosuppression, prior SBRT to current lesions, and uncontrolled brain metastases.

ClinicalTrials.gov ID: NCT04563507