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A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) or Hormone Receptor-low positive/HER2-negative Breast Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520190-12-00
Acronym
MK-2870-032
Enrollment
389
Registered
2025-08-27
Start date
2025-11-10
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer: triple negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2 negative breast cancer

Brief summary

Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Event-Free Survival (EFS)

Detailed description

Overall Survival (OS), pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0, pCR (ypT0/Tis ypN0) in Participants with High-Risk, Early-Stage, Triple Negative Breast Cancer (TNBC), EFS in Participants with High-Risk, Early-Stage, TNBC, OS in Participants with High-Risk, Early-Stage, TNBC, Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Change from Baseline in the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score, Change from Baseline in EORTC-QLQ-C30 Physical Functioning Score, Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Change from Baseline in EORTC QLQ-C30 Fatigue Score, Change from Baseline in EORTC QLQ-Breast Cancer Questionnaire (BR42) Systemic Therapy Side Effects, Number of Participants with One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Intervention Due to an AE

Interventions

DRUGCYCLOPHOSPHAMIDE
DRUGEPIRUBICIN
DRUGCAPECITABINE
DRUGCARBOPLATIN
DRUGDOXORUBICIN
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGPACLITAXEL
DRUGDEXAMETHASONE

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Event-Free Survival (EFS)

Secondary

MeasureTime frame
Overall Survival (OS), pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0, pCR (ypT0/Tis ypN0) in Participants with High-Risk, Early-Stage, Triple Negative Breast Cancer (TNBC), EFS in Participants with High-Risk, Early-Stage, TNBC, OS in Participants with High-Risk, Early-Stage, TNBC, Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Change from Baseline in the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score, Change from Baseline in EORTC-QLQ-C30 Physical Functioning Score, Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Change from Baseline in EORTC QLQ-C30 Fatigue Score, Change from Baseline in EORTC QLQ-Breast Cancer Questionnaire (BR42) Systemic Therapy Side Effects, Number of Participants with One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Intervention Due to an AE

Countries

Belgium, Finland, France, Greece, Hungary, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026