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An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504918-29-00
Acronym
MK-2870-010
Enrollment
438
Registered
2024-05-13
Start date
2024-08-22
Completion date
Unknown
Last updated
2026-01-26

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

Conditions

Hormone receptor positive breast cancer

Brief summary

Progression-Free Survival (PFS) (MK-2870 versus treatment of physician’s choice [TPC]; MK-2870 + pembrolizumab versus TPC)

Detailed description

1. Overall Survival (OS), 2. Progression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870), 3. Objective Response Rate (ORR), 4. Duration of Response (DOR), 5. Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), 6. Change from baseline in physical functioning score, on the EORTC QLQ-C30, 7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30, 8. Change from baseline in fatigue score, on the EORTC QLQ-C30, 9. Change from baseline in diarrhea score, on the EORTC QLQ-C30, 10. Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30, 11. TTD in physical functioning score, on the EORTC QLQ-C30, 12. TTD in emotional functioning score, on the EORTC QLQ-C30, 13. TTD in fatigue score, on the EORTC QLQ-C30, 14. TTD in diarrhea score, on the EORTC QLQ-C30, 15. Number of participants who experience one or more Adverse Events (AEs), 16. Number of participants who discontinue study treatment due to an AE

Interventions

DRUG-
DRUGPACLITAXEL
DRUGDOXORUBICIN HYDROCHLORIDE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDOXORUBICIN
DRUGCAPECITABINE
DRUGPACLITAXEL ALBUMIN-BOUND
DRUGDEXAMETHASONE
DRUGPARACETAMOL

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS) (MK-2870 versus treatment of physician’s choice [TPC]; MK-2870 + pembrolizumab versus TPC)

Secondary

MeasureTime frame
1. Overall Survival (OS), 2. Progression-Free Survival (PFS) (MK-2870 + pembrolizumab versus MK-2870), 3. Objective Response Rate (ORR), 4. Duration of Response (DOR), 5. Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), 6. Change from baseline in physical functioning score, on the EORTC QLQ-C30, 7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30, 8. Change from baseline in fatigue score, on the EORTC QLQ-C30, 9. Change from baseline in diarrhea score, on the EORTC QLQ-C30, 10. Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30, 11. TTD in physical functioning score, on the EORTC QLQ-C30, 12. TTD in emotional functioning score, on the EORTC QLQ-C30, 13. TTD in fatigue score, on the EORTC QLQ-C30, 14. TTD in diarrhea score, on the EORTC QLQ-C30, 15. Number of participa

Countries

Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

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