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Be Part of Research - Trial Details - A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Breast Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2024 Jul 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Arm A: Sacituzumab tirumotecan;Arm B:Pembrolizumab + Sacituzumab tirumotecan;

Intervention Type : BIOLOGICAL
Intervention Description : IV infusion

Intervention Arm Group : Arm B:Pembrolizumab + Sacituzumab tirumotecan;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Arm C: Treatment of Physician's Choice (TPC);

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Arm C: Treatment of Physician's Choice (TPC);

Intervention Type : DRUG
Intervention Description : oral tablet

Intervention Arm Group : Arm C: Treatment of Physician's Choice (TPC);

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Arm C: Treatment of Physician's Choice (TPC);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
    London
    London, City Of
    EC1A 7BE
  • The Royal Cornwall Hospital ( Site 1943)
    Truro
    England
    TR1 3LJ
  • City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)
    Nottingham
    NG5 1PB
  • University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
    London
    London, City Of
    NW1 2PG
  • Blackpool Victoria Hospital ( Site 1941)
    Blackpool
    FY3 8NR
  • North West Cancer Centre ( Site 1944)
    Londonderry
    Derry And Strabane
    BT47 6SB


The study is sponsored by Merck Sharp & Dohme LLC




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Read full details for Trial ID: NCT06312176
Last updated 15 May 2025

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