Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: MK-2870 (4 mg/kg): Dose: Adults, intravenous (IV), once every 2 weeks (q2w)
Intervention2: Pembrolizumab (400 mg): Dose: Adults, intravenous (IV), once every 6 weeks (q6w)
Control Inte
Sponsors
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
Eligibility
Inclusion criteria
Inclusion criteria: Is an individual of any sex/gender, from at least 18 years of age at the time of providing the informed consent. Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer 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 Is a chemotherapy candidate Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization Has adequate organ function Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy 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 Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria
Exclusion criteria: Has breast cancer amenable to treatment with curative intent Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer Active autoimmune disease that has required systemic treatment in the past 2 years History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease Has breast cancer amenable to treatment with curative intent Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer Active autoimmune disease that has required systemic treatment in the past 2 years History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival PFS sacituzumab tirumotecan versus treatment of physicians choice TPC pembrolizumab + sacituzumab tirumotecan versus TPCTimepoint: From time of signing the informed consent form | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in physical functioning score, on the EORTC QLQ-C30Timepoint: Baseline & upto 77 months;Overall SurvivalTimepoint: upto 77 months;Objective Response RateTimepoint: Up to 57 months;Progression-Free Survival PFS sacituzumab tirumotecan versus treatment of physicians choice TPC pembrolizumab + sacituzumab tirumotecan versus TPCTimepoint: Up to 57 months;Duration of Response (DOR)Timepoint: Up to 57 months;Change from baseline in physical functioning score, on the EORTC QLQ-C30 Timepoint: Baseline & upto 77 months;Change from baseline in emotional functioning score, on the EORTC QLQ-C30Timepoint: upto 77 months;Change from baseline in fatigue score, on the EORTC QLQ-C30Timepoint: Baseline & upto 77 months;Change from baseline in diarrhea score, on the EORTC QLQ-C30Timepoint: Baseline & upto 77 months;Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30Timepoint: upto 77 months;TTD in physical functioning score, on the EORTC QLQ-C30Timepoint: upto 77 months;TTD in emotional functioning score, on the EORTC QLQ-C30Timepoint: upto 77 months;TTD in fatigue score, on the EORTC QLQ-C30Timepoint: upto 77 months;TTD in diarrhea score, on the EORTC QLQ-C30Timepoint: upto 77 months;Number of participants who experience one or more adverse events (AEs)Timepoint: upto 77 months;Number of participants who discontinue study treatment due to an AETimepoint: Up to 77 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed