MK-2870-010 - TROFUSE-10 (JCP156)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/​HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

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Population: HR+/HER2- advanced or metastatic breast cancer

Line of therapy: 2L - After Progression on Previous Endocrine Therapy in Combination With a CDK4/​6 Inhibitor

Intervention: Sacituzumab tirumotecan vs. Sacituzumab tirumotecan + Pembrolizumab VS TPC

Key Inclusion Criteria

1. Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer

2. Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor

3. Is a chemotherapy candidate

4. Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization

5. Has adequate organ function

6. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy

7. Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load

8. Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

   
   

Key Exclusion Criteria

1. Has breast cancer amenable to treatment with curative intent

2. Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment

3. Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications

4. Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer

5. Active autoimmune disease that has required systemic treatment in the past 2 years

6. History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease.

7. Has an active infection requiring systemic therapy

Sponsor: Merck Sharp & Dohme LLC

CRP Contact: Dr. C. Ferrario

CRP PI: Dr. C. Ferrario

Status: Open to accrual