NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

765

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

March 31, 2033

Study Completion Date

March 31, 2033

Conditions
Breast CancerTriple-negative Breast Cancer
Interventions
DRUG

Sacituzumab govitecan

"SG is administered at 10 mg/kg as an intravenous (i.v.) infusion on Days 1 and 8 of a 21-day cycle.~The dose of SG will be calculated based on actual weight at randomization (using weight obtained either at enrolment or on Cycle 1 Day 1) and remains constant throughout the study, unless there is a \> 10% change in body weight from baseline. Modifications to the study drug doses administered should be made for a \> 10% change in body weight from baseline and according to local and regional prescribing standards. Dose modifications for changes in body weight \< 10% may be made according to local institutional guidelines.~SG is administered via i.v. infusion as described below with additional information available in the current version of the SmPC."

DRUG

Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]

Pembrolizumab 200 mg will be administered as a 30-minute i.v. infusion every 3 weeks.

DRUG

SoC Chemotherapy

Standard of care chemotherapy as per common treatment guidelines and recommendations

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

West German Study Group

OTHER