P-Rad in Node-Positive HER2-Negative Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether a radiation therapy boost in combination with chemotherapy and immunotherapy before surgery helps the immune system to destroy cancer cells.

What is the Condition Being Studied?

Early Stage Node-Positive Triple Negative Breast Cancer

Who Can Participate in the Study?

Adults who:
- Have been diagnosed with early stage node-positive triple negative breast cancer
- Are eligible to have paclitaxel and dose-dense doxorubicin chemotherapies before surgery
- Have not received prior immunotherapy

For more information about this study, please contact the study team at 919-660-1278.

Age Group
Adults

What is Involved?

If you choose to join this study you will:
- Be randomly assigned to 1 of 3 groups
-- One group will have immunotherapy and chemotherapy without a radiation therapy boost
-- One group will have low-dose radiation therapy boost plus immunotherapy, followed by immunotherapy and chemotherapy
-- One group will have high-dose radiation therapy boost plus immunotherapy, followed by immunotherapy and chemotherapy
- Answer questionnaires
- Have blood draws
- Have biopsies
- Give us permission to store your tissue samples
- Have imaging scans
- Have photographs of your breasts taken by your care team to monitor changes

After study treatment, you will have surgery as determined by you and your doctor. You will return to our clinic for follow-up visits to see how you are doing.

Study Details

Full Title
P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00109284
NCT: NCT04443348
Phase
Phase Pilot
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698