High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Triple-Negative Breast Carcinoma

Interventions

RADIATION

Radiation Therapy

Undergo radiation therapy

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Nab-paclitaxel

Given IV

DRUG

Paclitaxel

Given IV

DRUG

Carboplatin

Given IV

DRUG

Gemcitabine

Given IV

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Medical Chart Review

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Manali Bhave, MD · Emory University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-22

Primary Completion

2027-02-12

Completion

2028-02-13

FDA Drug

Yes

Countries

• United States

Study Locations