Laura M. Spring, MD
Laura M. Spring, MD
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)
Triple Negative Breast Cancer
Hormone Receptor Positive (HR+), HER2-negative Breast Cancer
Biopsy-proven, Positive Lymph Node(s)
Radiation Therapy Boost
Pembrolizumab
Paclitaxel
Carboplatin
Cyclophosphamide
Doxorubicin
Capecitabine
PHASE2
The main purpose of this study is to find out what is the best dose of preoperative RT when combined with pembrolizumab and chemotherapy. The study will assess if combining the RT with the immunotherapy agent, pembrolizumab, will increase the ability of the immune system to destroy cancer cells. The research study procedures include: screening for eligibility and study treatment, including evaluations and follow-up visits. The study aims to assess the effectiveness of pembrolizumab (study drug) with or without RT directed to the breast tumor. Participants will then undergo neoadjuvant chemotherapy with pembrolizumab, followed by treatment that can consist of one or more of the following: * Pembrolizumab (optional, per MD discretion) * Standard of Care Treatment * Breast surgery (lumpectomy or mastectomy) and axillary surgery * Adjuvant radiation to the entire breast or chest wall, plus or minus the lymph nodes after surgery * Adjuvant chemotherapy (optional Capecitabine for TNBC patients) * Hormone therapy Participants will be randomized to 1 of 3 groups. Neither the participant not the research doctor will choose the group that the participant is assigned to. However, the participant will be notified of the group prior to the start of study treatment. Participants will receive study treatment for up to 13 months. Participants will be followed for 2 years after the end of the study treatment. It is expected that a total of 120 people will be participating in total. This research study is a randomized, phase II study. The U.S. Food and Drug Administration (FDA) has not approved pembrolizumab for your specific disease, but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has approved the chemotherapies being used in this study (Paclitaxel, Doxorubicin, Cyclophosphamide, Carboplatin, Capecitabine).
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 120 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer |
Actual Study Start Date : | 2020-12-16 |
Estimated Primary Completion Date : | 2024-06 |
Estimated Study Completion Date : | 2024-12 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
RECRUITING
Johns Hopkins
Baltimore, Maryland, United States, 21231
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
RECRUITING
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
RECRUITING
Montefiore Medical Center
Bronx, New York, United States, 10467
RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
RECRUITING
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27514
RECRUITING
Duke University Medical Center
Durham, North Carolina, United States, 27710
NOT YET RECRUITING
MD Anderson Cancer Center
Houston, Texas, United States, 77030