Clinical Trials for Breast Cancer

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative 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.

TrialFetch AI summary: This trial enrolls adult women with recurrent, unresectable, locally advanced, or metastatic HER2-negative, androgen receptor-positive breast cancer (including both hormone receptor-positive and triple-negative subtypes), testing the combination of abemaciclib (a CDK4/6 inhibitor) and bicalutamide (an androgen receptor antagonist). Eligible patients may have had prior endocrine or cytotoxic therapy, and both pre- and postmenopausal women are included.

ClinicalTrials.gov ID: NCT05095207

Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative 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.

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.

TrialFetch AI summary: This trial enrolls adults with PD-L1-negative, treatment-naïve, metastatic triple-negative breast cancer to receive sacituzumab govitecan (a Trop-2-directed antibody-drug conjugate delivering SN-38) with or without pembrolizumab (an anti-PD-1 inhibitor). Eligible patients must have accessible tumor for biopsies and adequate organ function.

ClinicalTrials.gov ID: NCT04468061

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

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.

TrialFetch AI summary: This trial enrolls adults with newly diagnosed, untreated de novo HER2-positive metastatic breast cancer (including those with stable, treated brain metastases), testing a sequential regimen of standard HER2-targeted therapies: taxane/trastuzumab/pertuzumab, then trastuzumab deruxtecan (HER2-targeted ADC with a topoisomerase I payload), followed by T-DM1 plus tucatinib (HER2 TKI), and finally trastuzumab/pertuzumab/tucatinib, with the intent to intensify therapy upfront and then discontinue treatment.

ClinicalTrials.gov ID: NCT06439693

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients 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

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors, specifically HR+/HER2- breast cancer progressed after standard therapy or CCNE1-amplified malignancies (including ovarian, endometrial, TNBC), to receive AVZO-021, an oral selective CDK2 inhibitor targeting cell cycle dysregulation, as monotherapy or in combination with standard agents. Patients must have measurable disease, ECOG 0–1, and no prior CDK2 inhibitor exposure.

ClinicalTrials.gov ID: NCT05867251

Phase I Study Targeting DNA Methyltransferases in Metastatic 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.

TrialFetch AI summary: Adults with metastatic or unresectable triple-negative breast cancer (ER/PR ≤10%, HER2−), ECOG 0–2, including those with prior PD-1/PD-L1 therapy and treated/stable brain metastases, receive paclitaxel plus pembrolizumab combined with ASTX727 (oral decitabine, a DNA methyltransferase inhibitor, and cedazuridine, a cytidine deaminase inhibitor) to evaluate safety and dosing. Up to three prior metastatic chemotherapy lines allowed; key exclusions include active autoimmune disease requiring recent immunosuppression and uncontrolled intercurrent illness.

ClinicalTrials.gov ID: NCT05673200

Pilot Study of Cemiplimab and Hepatic Radioembolization in Patients With Liver Dominant 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.

TrialFetch AI summary: Adults with liver-dominant metastatic breast cancer (ECOG 0–1) previously treated with at least one line of metastatic chemotherapy and with liver tumor burden <50% receive cemiplimab (anti–PD-1 antibody) every 3 weeks combined with two sessions of hepatic Y-90 radioembolization; controlled extrahepatic disease allowed, but no cirrhosis, recent immunotherapy, or progressing/untreated extrahepatic disease. The study assesses intratumoral immune activation and safety, with biopsies around TARE sessions and response of treated hepatic lesions.

ClinicalTrials.gov ID: NCT06860815