Sacituzumab Tirumotecan for Triple-Negative Breast Cancer

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Recruiting Phase 3 Interventional Study
Triple Negative 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.
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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
1,000 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with triple-negative breast cancer that cannot be treated with a cure. Participants will receive either sacituzumab tirumotecan alone or combined with another medication called pembrolizumab to see how well it works compared to standard chemotherapy.

Are You a Good Fit for This Trial?
Rules you out Severe dry eye syndromeSevere Meibomian gland diseaseSevere blepharitisSevere corneal diseaseInflammatory bowel diseaseActive autoimmune diseaseHistory of pneumonitisHistory of central nervous system metastases

You may be able to join if

  • I have triple-negative breast cancer that cannot be cured.
  • I have not received treatment for my breast cancer that has come back or spread.
  • I completed prior treatment for early-stage breast cancer at least 6 months ago.
  • I qualify for treatment with pembrolizumab and certain chemotherapy options.
  • I have recovered from previous side effects of cancer treatment.
  • I have positively managed hepatitis B if I was diagnosed.
  • I have undetectable hepatitis C if I had a previous infection.

You may not be able to join if

  • I have breast cancer that can be cured.
  • I have triple-negative breast cancer with a specific high PD-L1 expression.
  • I have had treatment for breast cancer that has come back or spread.
  • I have significant nerve damage.
  • I have severe eye or skin diseases that affect healing.
  • I have untreated serious heart or brain diseases.
  • I have an active infection related to hepatitis B or C.
  • I had a stem cell or organ transplant.

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

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent * Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer * P…
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