Sacituzumab tirumotecan / Triple Negative Breast Neoplasms / Pembrolizumab · Phase 3 Trial

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)

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 randomized trial of sacituzumab tirumotecan alone and in combination with pembrolizumab versus treatment of physician's choice in triple-negative breast cancer. The trial is actively recruiting with no results yet available in this registry record.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Triple Negative Breast Neoplasms; age from 18 Years. Intervention: Arm A: Sacituzumab Tirumotecan; Arm B: Sacituzumab Tirumotecan + Pembrolizumab. Compared with: Arm C: Treatment of Physician's Choice (TPC) — Active Comparator. n = 1,000. 268 sites across 34 countries.

Key findings

Safety

This is a registry record; no efficacy or safety results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registration with no results yet posted; the study is actively recruiting and outcomes are not yet reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC) (assessed at Up to ~39 months); Overall Survival (OS) (sac-TMT versus TPC) (assessed at Up to ~61 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationTriple Negative Breast Neoplasms; age from 18 Years

Sample size1,000

InterventionArm A: Sacituzumab Tirumotecan; Arm B: Sacituzumab Tirumotecan + Pembrolizumab

ComparatorArm C: Treatment of Physician's Choice (TPC) — Active Comparator

Setting268 sites across 34 countries

Reported figures

Quoted from the source exactly as published.

Estimated sample size1000

Primary outcome measure 1Progression-free survival (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC), up to ~39 months

Primary outcome measure 2Overall survival (sac-TMT versus TPC), up to ~61 months

PhasePhase 3

Caveats

This is a registry record; no efficacy or safety results are reported.
Recruitment status is 'recruiting'; enrollment may not be complete.
Study design details such as blinding, stratification, and statistical analysis plan are not provided in this registry entry.
Follow-up duration is estimated (~39 months for PFS, ~61 months for OS); actual durations are unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 interventional trial with planned randomization and comparative arms.

Directness

strong

Hard clinical endpoints: progression-free survival and overall survival in TNBC.

Consistency

insufficient

No results posted; consistency with prior evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or other bias mitigation.

Sample adequacy

strong

Estimated enrollment 1000 participants; large sample size for Phase 3.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06841354). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Triple Negative Breast Neoplasms. Interventions: BIOLOGICAL: Sacituzumab tirumotecan; BIOLOGICAL: Pembrolizumab; DRUG: Rescue Medication; DRUG: Paclitaxel; DRUG: Nab-paclitaxel; DRUG: Gemcitabine; DRUG: Carboplatin. Primary outcome measures: Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC) , Up to ~39 months; Overall Survival (OS) (sac-TMT versus TPC) , Up to ~61 months. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Sacituzumab tirumotecanTriple Negative Breast NeoplasmsMerck Sharp & DohmePembrolizumabRescue MedicationNCT06841354Paclitaxel