MK-2870-010
A Study of Sacituzumab Tirumotecan 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
Recruiting
Trial Purpose
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician’s Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
View more trial information on ClinicalTrials.gov
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National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. | NCT06312176 |
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MSD Protocol ID |
MK-2870-010 |
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Conditions |
Breast Neoplasms |
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Age Range |
18+ |
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SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. | ALL |
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Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. | 3 |
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Start Date End Date |
2024-04-14 2031-04-12 |
Study Details
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.
Conditions
Breast Neoplasms
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial Locations
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What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
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