OPTIMICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients who Achieve PCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
- Sponsor:
- Alliance for Clinical Trials in Oncology
- Sponsor Study ID:
- A012103
- CTO #:
- 103984
- NCT Number:
- NCT05812807
- Phase:
- III
- Protocol Type:
- Treatment
- Age Group:
- Adults
- Disease Sites:
- Breast
- Study Objectives:
- To evaluate whether observation results in a non-inferior RFS compared to adjuvant pembrolizumab in early-stage TNBC patients who achieve a pCR after neoadjuvant chemotherapy with pembrolizumab
- eConsent:
- Not available
- Study Documents:
-
Open Study Documents
(MUSC NetID required for document access)
For more information about this trial please contact the study team:
-
Medical University of South Carolina
- Principal Investigator, Brescia, Frank, at bresciaf@musc.edu .
- Study Coordinator, Gelardi, Theresa, at gelardi@musc.edu .
-
Self Regional Medical Center
- Affiliate Principal Investigator, Metzner-Sadurski, Joanna, at jsadurski@selfregional.org .
- Study Coordinator, Collins, Lydia, at lydia.collins@selfregional.org .
- Study Coordinator, Blalock, Margaret, at margaret.bentley@selfregional.org .
-
Tidelands Health
- Affiliate Principal Investigator, Milling, Lee, at leemilling@gmail.com .
- Study Coordinator, DeNunzio, Cara, at cdenunzio@tidelandshealth.org .
- Study Coordinator, Roe, Barbara, at broe@tidelandshealth.org .
Trial opened at the following institutions:
Tidelands Health, Self Regional Medical Center, Medical University of South Carolina