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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients who Achieve pCR after Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Objective

To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy with pembrolizumab; II. To compare quality of life (QOL) at approximately 27 weeks as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To assess the social value of de-escalation of adjuvant breast cancer immunotherapy at approximately 27 weeks and, by modeling, over a lifetime. (Value of Care)

Protocol #

A012103

Trial Phase:

Phase III

Principal Investigator:

Ross, Masey

Cancer Type
  • Breast
Study Site
  • Stony Point
  • Virginia Commonwealth University

Age >/= 18 years
History of stage T1cN1-2 or T2-4N0-2 breast cancer per AJCC 8th edition
Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy
ER and PR </=10%; HER2-negative by ASCO/CAP guidelines (IHC and FISH)

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Lindsey Gwaltney, MS, RN
    Phone: +1 804-628-2112
    Email Study Contact

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