Actively Recruiting
A Phase 3 Study Comparing Sacituzumab Tirumotecan Alone and With Pembrolizumab Versus Physicians Choice Chemotherapy in Participants With Untreated Locally Recurrent or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 Less Than 10
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
1000
Participants Needed
261
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating sacituzumab tirumotecan alone or combined with pembrolizumab to treat triple negative breast cancer TNBC that is locally recurrent, unresectable, or metastatic and expresses PD-L1 at a combined positive score less than 10. The study aims to determine if these treatments help people live longer overall or without their cancer growing or spreading compared to chemotherapy selected by their physician. This is a phase 3, randomized, open-label study sponsored by Merck Sharp Dohme LLC. Participants are randomly assigned to one of three groups sacituzumab tirumotecan given intravenously every two weeks sacituzumab tirumotecan every two weeks plus pembrolizumab every six weeks for up to about two years or chemotherapy chosen by the physician, which includes options like paclitaxel, nab-paclitaxel, gemcitabine plus carboplatin with various dosing schedules. Pre-medications are given before sacituzumab tirumotecan infusions to help manage side effects. Treatments continue until disease progression, unacceptable side effects, or discontinuation. During the study, participants will be monitored for overall survival and progression-free survival up to about 61 months. Researchers will assess tumor response, duration of response, quality of life using questionnaires, and safety including adverse events and treatment discontinuations. The study includes regular visits for treatment administration, assessments, and follow-up to evaluate how participants respond and tolerate the treatments over time.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have locally recurrent unresectable or metastatic triple negative breast cancer not treatable with curative intent
- Have not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
- Completed prior therapy for early-stage breast cancer with curative intent at least 6 months before recurrence if previously treated
- Are candidates for pembrolizumab and one of the physician's choice chemotherapy options: paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin
- Have recovered to Grade 1 or baseline from adverse events due to previous anticancer therapies except alopecia or vitiligo
- Participants with endocrine-related adverse events adequately treated with hormone replacement are eligible
- Hepatitis B surface antigen positive participants are eligible if on antiviral therapy for at least 4 weeks with undetectable viral load
- Participants with history of hepatitis C infection are eligible if viral load is undetectable
You will not qualify if you...
- Breast cancer that can be treated with curative intent
- Triple negative breast cancer with PD-L1 expression at combined positive score of 10 or higher
- Prior systemic therapy for locally recurrent unresectable or metastatic breast cancer
- Grade 2 or higher peripheral neuropathy
- Severe dry eye syndrome, Meibomian gland disease, blepharitis, or corneal disease affecting healing
- Active inflammatory bowel disease requiring immunosuppressive medication or history of inflammatory bowel disease
- Uncontrolled significant cardiovascular or cerebrovascular disease
- Skin-only metastatic disease
- Advanced or symptomatic visceral metastases at risk of rapid life-threatening complications
- History of Kaposi's sarcoma or Multicentric Castleman's Disease in HIV-infected participants
- Known additional malignancy progressing or treated in past 5 years
- Active central nervous system metastases or carcinomatous meningitis unless stable after treatment
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapies
- History or current pneumonitis or interstitial lung disease requiring steroids or suspected but unconfirmed
- Concurrent active Hepatitis B and Hepatitis C infection
- History of stem cell or solid organ transplant
- Not recovered from major surgery or ongoing surgical complications
Research Team
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