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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06492759
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Nab-paclitaxel — DRUG
    Given IV
  • Paclitaxel — DRUG
    Given IV
  • Carboplatin — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Medical Chart Review — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Apr 2026
Primary completion
Feb 12, 2027
Completion
Feb 13, 2028

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (radiation, pembrolizumab, chemotherapy)
    Patients undergo radiation therapy once every other day for 3 doses. Beginning within 48 hours of their first dose of radiation therapy, patients receive standard of care pembrolizumab IV on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive 1 of 3 standard of care chemotherapy options: nab-paclitaxel IV on days 1, 8, and 15 of each cycle, or paclitaxel IV on days 1, 8, and 15 of each cycle, or carboplatin IV and gemcitabine IV on days 1 and 8 of each cycle. Cycles of nab-paclitaxel and paclitaxel repeat every 28 days and cycles of carboplatin and gemcitabine repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy at baseline and 2 weeks after radiation therapy and also undergo CT scans, bone scans and blood sample collections throughout the trial.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From start of radiation therapy to progression or death, assessed at 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Ashley Lynn Trumbull
[email protected]
404-778-3969
Manali A. Bhave, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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