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.
Who Can Participate?
Eligibility
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.
- 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 Range
18-90
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
- 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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer
Principal Investigator
Susan
Dent
Protocol Number
PRO00109284
NCT ID
NCT04443348
Phase
Pilot
Enrollment Status
OPEN TO ACCRUAL