OptimICE-PCR (Triple Negative Breast Cancer) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Triple-Negative Breast Cancer (TNBC)

Who Can Participate in the Study?

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

For more information, contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

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.

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
Medical Oncologist
Protocol Number
IRB: PRO00116988
NCT: NCT05812807
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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