Sacituzumab Tirumotecan for Advanced Breast Cancer

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 Phase 3 Interventional Study
Breast Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,200 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with advanced breast cancer that is hormone receptor positive and HER2 negative. Participants will receive sacituzumab tirumotecan on its own or with another medication called pembrolizumab to see how well it works compared to other treatments.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with advanced hormone receptor positive breast cancer.
  • I have seen my cancer worsen after one or more hormone therapies.
  • I am a candidate for chemotherapy.
  • I have good overall health with an ECOG status of 0 to 1.
  • I have adequate organ function.
  • I am HIV positive and well managed on treatment.
  • I am Hepatitis B positive but have received treatment and have an undetectable viral load.
  • I have a history of Hepatitis C, but my viral load is undetectable.

You may not be able to join if

  • I have breast cancer that can be treated with curative intent.
  • I have had a cancer recurrence within 6 months after initial therapy.
  • I have serious complications from advanced cancer.
  • I have received chemotherapy for my advanced breast cancer before.
  • I have an active autoimmune disease requiring treatment in the last 2 years.
  • I have a history of serious lung problems needing steroids.
  • I have an ongoing infection that needs treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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…
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