Purpose of this Study
We are doing this study to find out what strategy after surgery has the best outcomes for patients with triple-negative breast cancer who have a complete response to chemotherapy before their surgeries. We want to compare 27 weeks of treatment with pembrolizumab after surgery to 27 weeks of monitoring without drug treatment and find out if there is a difference in terms of risk of having the cancer come back.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have stage II or II breast cancer prior to preoperative chemotherapy
- Have no detectable disease left in the breast or lymph nodes after completion of preoperative therapy
- Are HER2-negative
- Had their surgery less than 12 weeks before their study regimen assignment date
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: If you are in this group, you will receive 27 weeks of pembrolizumab treatment after your breast surgery. You will get this drug through a vein in the arm on the first day of each cycle. You may receive pembrolizumab every 3 weeks for 9 cycles (one cycle being 21 days in length). Or, you may receive pembrolizumab every 6 weeks for 4 cycles (one cycle being 42 days in length), followed by one additional dose of pembrolizumab to complete 27 weeks of therapy. Your doctor will choose which treatment schedule you will be on.
- Group 2: If you are in this group, you will be observed by the study doctors at the beginning of the study, 12 weeks after starting the study, and 27 weeks after you start the study. You will not receive pembrolizumab.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A012103: OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Principal Investigator
Alexandra
Thomas
Protocol Number
PRO00116988
NCT ID
NCT05812807
Phase
III
Enrollment Status
Open to Enrollment