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

Brief description of study

OptimICE-pCR is a randomized phase III trial that is enrolling early-stage TNBC patients with a pCR after the completion of neoadjuvant therapy consisting of a minimum of 6 cycles of chemotherapy in combination with an ICI. Patients are randomized 1:1 to receive 27 weeks of adjuvant pembrolizumab or observation. Schedule of pembrolizumab is per physician’s choice, with a choice of either pembrolizumab 200 mg IV administered on day 1 of each 21-day cycle or 400 mg IV administered on day 1 of every 42-day cycle. If every 42 day (6 week dosing) is chosen, then 4 doses of 400 mg IV every 42 days can be administered followed by one cycle of 200 mg IV every 21 days, so that a total of 27 weeks of pembrolizumab is received.

Clinical Study Identifier: s23-00607

ClinicalTrials.gov Identifier: NCT05812807

Principal Investigator: Natalie Jill Klar.

Other Investigators: Yelena Novik, Maryann J Kwa, Nina D'Abreo, Marleen I Meyers, Ariel Karwat, Amanda Marie Buzolich, Yael Simons, Wanqing Iris Zhi, Yan Fon Mei, Danielle Seidman, Nancy Chan, Caitlin Elizabeth Ryan, Anastasiya Apanasyuk, Alexander A Hindenburg, Ruth Oratz, Douglas K Marks.

Contact the research team to learn more about this study.

Your Email

Not a valid e-mail address

Please Provide Email Address

First Name

First name is mandatory

Last Name

Your Phone

Please provide phone number

Invalid phone number

Valid phone number

Comments

Send Confirmation of This To Me

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Perlmutter Cancer Center

Clinical Trials & Research Studies