Actively Recruiting
High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
Led by Emory University · Updated on 2026-04-17
29
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven metastatic PD-L1 positive triple negative breast cancer with at least 2 measurable metastatic sites
- Estrogen and progesterone receptor negativity defined as 10% or less cell expression by immunohistochemistry
- HER2 negativity defined by specific lab tests (ISH non-amplified or IHC 0 or 1+)
- PD-L1 positivity with combined positive score of 10 or higher by Dako 22c3 assay
- History and physical exam within 60 days before registration
- CT scans of chest, abdomen, pelvis with bone scan or PET/CT within 4 weeks before radiation start
- Eligible for radiotherapy, immunotherapy, and taxane chemotherapy as determined by physician
- At least 1 metastatic site suitable for high dose radiation
- Age 18 years or older
- ECOG performance status 0 to 2 or Karnofsky score 60% or higher
- Measurable disease by RECIST 1.1
- Adequate blood counts and organ function within 14 days before treatment
- Negative pregnancy test for females of child-bearing potential within 14 days before radiation
- Ability to provide informed consent
- No chemotherapy in advanced/metastatic setting before study
- Prior radiotherapy or chemotherapy for early breast cancer allowed if completed and side effects resolved
- No active wound healing issues from surgery
- Bisphosphonate or RANK-L inhibitor use allowed prior to enrollment
You will not qualify if you...
- Prior chemotherapy or targeted therapy for metastatic triple negative breast cancer before pembrolizumab plus chemotherapy
- Previous radiation to metastases targeted in this study
- Untreated central nervous system disease (stable treated CNS metastases allowed)
- Uncontrolled pleural, pericardial effusion, or ascites (patients with indwelling catheters allowed)
- Uncontrolled or symptomatic hypercalcemia requiring ongoing bisphosphonate or denosumab
- History of autoimmune disease requiring systemic treatment
- Current use of chronic systemic steroids or immunosuppressants
- Prior allogeneic stem cell or organ transplant
- Severe heart conditions within last 6 months
- Active bacterial or fungal infection requiring IV antibiotics
- History or evidence of certain lung diseases or active pneumonitis
- Chronic respiratory illness requiring hospitalization
- HIV positive with low CD4 count
- Other progressing cancers needing treatment (except certain skin or indolent cancers)
- Conditions or treatments interfering with trial participation or safety, including recent major surgery
- Known allergy to nab-paclitaxel or excipients
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning conception during study and 90 days after last treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
M
Manali Bhave, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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