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

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 hypothesi

Trial Details

NCT ID
NCT06393374
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Pembrolizumab
  • Sacituzumab tirumotecan
  • Capecitabine
Locations (sample)
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Fountain Valley, California, United States|33.70918,-117.95367
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Alamitos, California, United States|33.80307,-118.07256

Key Eligibility Criteria

  • Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guide…
  • Has no evidence of locoregional or distant relapse, as assessed by the treating physician
  • Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemo…
  • Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from su…

For full eligibility, visit ClinicalTrials.gov.

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