Hormone receptor positive breast cancer
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) (MK-2870 versus treatment of physician’s choice [TPC]; MK-2870 + pembrolizumab versus TPC) | — |
Secondary
| Measure | Time 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