P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer

NCT04443348 Phase 2 ACTIVE_NOT_RECRUITING

This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are: * Radiation Therapy (RT) * Immunotherapy: Pembrolizumab (MK-3475) * Chemotherapies: * Paclitaxel * Doxorubicin (also called Adriamycin) * Cyclophosphamide * Carboplatin (optional, and in TN only) * Capecitabine (optional, and in TN only)

Details

Lead sponsor	Laura M. Spring, MD
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	120
Start date	2020-12-16
Completion	2027-08

Conditions

• Triple Negative Breast Cancer
• Hormone Receptor Positive (HR+), HER2-negative Breast Cancer
• Biopsy-proven, Positive Lymph Node(s)

Interventions

• Radiation Therapy Boost
• Pembrolizumab
• Paclitaxel
• Carboplatin
• Cyclophosphamide
• Doxorubicin
• Capecitabine

Primary outcomes

• Tumor Infiltrating Lymphocytes (TILs; CD3+/CD8+ T-cell Breast Immunoscore) — 14 through 21 Days
  Quantitative immunofluorescence in post-treatment tumor biopsy samples collected on day 14-21 of C1 of Pembrolizumab.
• Rate of pathologic response in the lymph node — 7 Months
  Defined as the percentage of patients no evidence of residual cancer cells in all sampled regional lymph nodes following completion of neoadjuvant systemic therapy assessed by the study pathologist at the time of definitive surgery.

Countries

United States