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

Condition studied

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

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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