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Breast CancerOpen to EnrollmentPhase 3

Breast: ADJUVANT: TNBC: Post-neoadjuvant: No pCR: MK 2870-012

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus 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

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Study snapshot

Title
Merck MK-2870-012 (Adjuvant Breast no pathCR from neoadj)
Malignancy
Breast cancer, triple negative breast cancer, TNBC
Stage
Stage 2
Disease setting
Adjuvant/Post-surgical
Line of therapy
Adjuvant
Investigational agent
sacituzumab tirumotecan
Drug class
Antibody drug conjugate
Principal investigator
Greg Vidal, MD, PhD
Sponsor
Merck Sharp and Dohme
Path
triple negative, ER-, PR-, HER2-
Randomized
Yes
ClinicalTrials.gov ID
NCT06393374

Eligibility and objectives

Key eligibility criteria details

  • Centrally confirmed TNBC
  • No evidence of locregional or distant relapse
  • Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxane and pembrolizumab with anthracycline-based chemotherapy) followed by surgery per NCCN guidelines for TNBC
  • Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
  • Is able to continue on adjuvant pembrolizumab
  • Has non-pathologic complete response at surgery
  • Completed adjuvant radiation therapy if indicated and recovered before randomization
  • Must be randomized within 16 weeks from surgery
  • ECOG PS 0-1
  • No known BRCA mutation
  • Cannot have received anticancer therapy in adjuvant setting
  • No additional malignancy that is progressing or has required active treatment within the last 5 years

Objective

  • Primary
    • Invasive DFS
  • Secondary
    • OS
    • Distant DFS
    • Safety
    • QOL

Treatment details