Clinical trial that compares MK-2870 with or without pembrolizumab to chemotherapy in people with breast cancer that cannot be surgically removed.

Phase 1

Conditions: Hormone receptor positive breast cancer
MedDRA version: 23.0Level: PTClassification code: 10083234Term: Hormone receptor positive breast cancer Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-504918-29-00

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1249

Inclusion Criteria

1.Has unresectable locally advanced or metastatic 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

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