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Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

NCT06393374 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1530

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Conditions

  • Triple-Negative Breast Cancer

Interventions

BIOLOGICAL

Pembrolizumab

Pembrolizumab 400 mg intravenous (IV) infusion q6w

BIOLOGICAL

Sacituzumab tirumotecan

Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2030-12-16
Completion
2037-12-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Norway
  • Poland
  • Portugal
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT06393374 on ClinicalTrials.gov