Sacituzumab tirumotecan / Capecitabine / Pembrolizumab · Phase 3 Trial

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

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 clinical trial registry record for an ongoing randomized comparison of sacituzumab tirumotecan plus pembrolizumab versus treatment of physician's choice in triple-negative breast cancer patients who did not achieve pathological complete response after neoadjuvant therapy. No efficacy or safety results are posted in this registry record; the study is actively recruiting.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Triple-Negative Breast Cancer; age from 18 Years. Intervention: Pembrolizumab + sacituzumab tirumotecan. Compared with: Treatment of Physician's Choice — Active Comparator. n = 1,530. 308 sites across 31 countries.

Key findings

Safety

No efficacy or safety results are reported in this registry record.

Who this may help

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

Plain-language summary

This is a Phase 3 RCT registration with no posted results; the study is actively recruiting and outcome data are not yet available for clinical interpretation.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Invasive Disease-Free Survival (iDFS) (assessed at Up to ~77 months)

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

PopulationTriple-Negative Breast Cancer; age from 18 Years

Sample size1,530

InterventionPembrolizumab + sacituzumab tirumotecan

ComparatorTreatment of Physician's Choice — Active Comparator

Setting308 sites across 31 countries

Reported figures

Quoted from the source exactly as published.

Primary endpointInvasive Disease-Free Survival (iDFS)

Follow-up durationUp to ~77 months

Planned enrollment1530

Study phasePhase 3

Caveats

No efficacy or safety results are reported in this registry record.
Study is open-label, introducing detection bias risk.
Results have not yet been posted; outcomes, effect sizes, and statistical significance are unknown.
Study recruitment status is active; no data on study completion or outcome reporting date are stated.

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

Randomized, open-label Phase 3 design stated explicitly in registry.

Directness

strong

Adjuvant setting in TNBC patients post-neoadjuvant therapy without pCR.

Consistency

insufficient

No results posted; consistency cannot be assessed at this stage.

Risk of bias

moderate

Open-label design introduces bias risk; no blinding reported.

Sample adequacy

strong

Planned enrollment 1530 participants; adequate for Phase 3 superiority trial.

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 (NCT06393374). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1530 participants (ESTIMATED). Conditions: Triple-Negative Breast Cancer. Interventions: BIOLOGICAL: Pembrolizumab; BIOLOGICAL: Sacituzumab tirumotecan; DRUG: Capecitabine. Primary outcome measures: Invasive Disease-Free Survival (iDFS) , Up to ~77 months. Brief summary: This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Follow from this

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

Sacituzumab tirumotecanNCT06393374CapecitabineMerck Sharp & DohmePembrolizumabTriple Negative Breast Cancer