OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
OptimICE-PCR: Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer
Sponsor: National Cancer Institute
Enrolling: Male and Female Patients
IRB Number: AAAV2954
U.S. Govt. ID: NCT05812807
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at preventing cancer from coming back? This study aims to find out if observation is as good as the usual approach for early-stage TNBC. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery.
Investigator
Meghna Trivedi, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Have you recently completed treatment of triple-negative breast cancer (TNBC) that resulted in no remaining cancer? Yes No
Are you willing to make regularly scheduled visits to the clinic for treatment and evaluation? Yes No
Submit
Cancel
You may be eligible for this study

Place Holder



Cancel
For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
This website uses cookies as well as similar tools and technologies to understand visitors’ experiences. By continuing to use this website, you consent to Columbia University’s usage of cookies and similar technologies, in accordance with the Columbia University Website Cookie Notice.
I AGREE