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Sacituzumab tirumotecan plus pembrolizumab and chemotherapy for high-risk early triple-negative and HR-low/HER2-negative breast cancer

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06966700

This trial will test whether adding sacituzumab tirumotecan and pembrolizumab to chemotherapy helps people with high‑risk early-stage triple‑negative or HR‑low/HER2‑negative breast cancer have fewer cancer cells in their tumors and lymph nodes before surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2400 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsradiation, Sacituzumab, pembrolizumab, chemotherapy
Locations283 sites (Gilbert, Arizona and 282 other locations)
Trial IDNCT06966700 on ClinicalTrials.gov

What this trial studies

This phase 3 study gives sacituzumab tirumotecan together with pembrolizumab and standard chemotherapy to people with previously untreated, high‑risk early‑stage triple‑negative or HR‑low/HER2‑negative breast cancer in the neoadjuvant setting. Participants must provide a core needle biopsy at screening for central confirmation of tumor subtype and will be closely monitored for tumor response and treatment safety. The primary focus is on the amount of residual cancer found in the breast and regional lymph nodes at the time of surgery. The trial is sponsored by Merck and is being conducted at several cancer centers in Arizona.

Who should consider this trial

Good fit: Ideal candidates are people with previously untreated, non‑metastatic high‑risk early breast cancer that is centrally confirmed as triple‑negative or HR‑low+/HER2‑negative, with ECOG performance status 0–1 who can provide a core biopsy and tolerate neoadjuvant chemoimmunotherapy.

Not a fit: Patients with metastatic disease, HER2‑positive tumors, ER expression above 10%, prior systemic therapy for this cancer, or poor performance status are unlikely to be eligible or to benefit from this neoadjuvant regimen.

Why it matters

Potential benefit: If successful, the combination could increase the chance of eliminating cancer cells before surgery and lower the risk of the cancer coming back.

How similar studies have performed: Combining PD‑1 inhibitors with chemotherapy has previously improved tumor clearance rates in early triple‑negative breast cancer, but using sacituzumab tirumotecan in this neoadjuvant setting is a newer approach with less prior clinical experience.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:

  * cT1c, N1-N2
  * cT2, N0-N2
  * cT3, N0-N2
  * cT4a-d, N0-N2
* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
* Demonstrates adequate organ function.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
* Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I inhibitor-containing ADC.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Uncontrolled systemic disease.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Where this trial is running

Gilbert, Arizona and 282 other locations

+233 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast NeoplasmsTriple Negative Breast NeoplasmsHR Low-Positive/HER2-Negative Breast NeoplasmsProgrammed Cell Death-1Programmed Cell Death 1 Ligand 1Programmed Cell Death 1 Ligand 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.