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

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 tu

Trial Details

NCT ID
NCT06492759
Phase
PHASE2
Sponsor
Emory University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Radiation Therapy
  • Pembrolizumab
  • Nab-paclitaxel
  • Paclitaxel
  • Carboplatin
  • Gemcitabine
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Biopsy proven metastatic PD-L1 positive triple negative breast cancer with at least 2 sites of measurable metastatic disease on imaging
  • Estrogen receptor (ER) and progesterone receptor (PR) negativity are defined as ≤ 10% of cells expressing hormonal receptors via immunohistochemist…
  • HER2 negativity is defined as either of the following by local laboratory assessment
  • In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell) or

For full eligibility, visit ClinicalTrials.gov.

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