West Cancer Center

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

Title

Merck MK-2870-012 (Adjuvant Breast no pathCR from neoadj)

Study Title

Site Link

NCT06393374

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

Greg Vidal, MD, PhD

Sponsor

Merck Sharp and Dohme

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

triple negative, ER-, PR-, HER2-

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes