High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
NCT Number: NCT06492759
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Anatomic Stage IV Breast Cancer AJCC v8|Metastatic Triple-Negative Breast Carcinoma
Interventions: RADIATION: Radiation Therapy|BIOLOGICAL: Pembrolizumab|DRUG: Nab-paclitaxel|DRUG: Paclitaxel|DRUG: Carboplatin|DRUG: Gemcitabine|PROCEDURE: Biopsy|PROCEDURE: Computed Tomography|PROCEDURE: Bone Scan|PROCEDURE: Biospecimen Collection|OTHER: Medical Chart Review
Sponsor: Emory University
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-02-13
Locations: Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States

Summary:
This phase II trial tests how well radiation therapy with pembrolizumab and chemotherapy (paclitaxel or nab-paclitaxel or carboplatin and gemcitabine) works in treating patients with PD-L1 positive triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Carboplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. High dose radiation therapy with pembrolizumab and chemotherapy may effective in treating patients with PD-L1 positive metastatic triple negative breast cancer.

Primary Outcome Measures: Progression-free survival (PFS), Progressive disease will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for 1-year PFS will be estimated using the Greenwood formula. The 1-year PFS estimate will be compared to a null value of 30% using a one-sample log-rank test., From start of radiation therapy to progression or death, assessed at 1 year
Secondary Outcome Measures: Objective response rate (ORR), Response will be defined by partial or complete response on imaging using RECIST version 1.1. ORR will be estimated as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method., At 9 weeks after first dose of pembrolizumab|Overall survival (OS), OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach., From start of radiation therapy to death, assessed up to 2 years|Incidence of adverse events (AEs), AEs will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5. Frequencies and percentages will be used to summarize safety events., Up to 90 days after the last dose of study treatment