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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

NCT05633654 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1514

Last updated 2026-04-30

No results posted yet for this study

Summary

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Conditions

Interventions

DRUG

Sacituzumab govitecan-hziy (SG)

Administered intravenously

DRUG

Pembrolizumab

Administered intravenously

DRUG

Capecitabine

Tablets administered orally

Sponsors & Collaborators

  • Alliance Foundation Trials, LLC.

    collaborator OTHER

  • NSABP Foundation Inc

    collaborator NETWORK

  • GBG Forschungs GmbH

    collaborator OTHER

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2027-06-30
Completion
2031-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • France
  • Germany
  • Ireland
  • Italy
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633654 on ClinicalTrials.gov