Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Official title

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

Study identification

NCT ID

NCT05812807

Recruitment status

Recruiting

Study type

Interventional

Phase

Phase 3

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Enrollment

1,295 participants

Conditions and interventions

Eligibility (public fields only)

Age range

18 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Jun 13, 2023

Primary completion

May 30, 2033

Completion

May 30, 2033

Last update posted

May 7, 2026

2023 – 2033

United States locations

U.S. sites

818

U.S. states

49

U.S. cities

599

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.