Back to search results

Study of Sacituzumab Tirumotecan for Early-Stage Breast Cancer

This study is investigating sacituzumab tirumotecan (Sac-TMT, MK-2870), a targeted therapy, for people with high-risk, early-stage breast cancer. This includes triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. Researchers are looking for new ways to treat these cancers, which may have a higher chance of returning. The study will also use other treatments like pembrolizumab, carboplatin, and paclitaxel. Success will be measured by how many participants have no remaining cancer cells at the time of surgery (pathological complete response) and how long they live without the cancer returning (event-free survival). This study is currently recruiting up to 2400 adults aged 18 and older.

Study design
This is an interventional study with a planned enrollment of 2400 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 92 months to measure event-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06966700

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~2,400 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanPembrolizumabRescue MedicationCarboplatinPaclitaxelDoxorubicin

At a glance

Recruiting sites
323 of 325 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery
Measured over Up to approximately 30 weeks
+1 more outcome measured

Conditions

Breast Neoplasms
Triple Negative Breast Neoplasms
HR Low-Positive/HER2-Negative Breast Neoplasms

Explore related trials

HR Low-Positive/HER2-Negative Breast NeoplasmsTriple-negative breast cancer

NCT06966700

Where you'd take part

This study runs at 325 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)

    Altamonte Springs, Floridastudy coordinator listed

    Recruiting

  • Akademiska sjukhuset ( Site 3801)

    Uppsala, Uppsala County, Swedenstudy coordinator listed

    Recruiting

  • Akershus Universitetssykehus ( Site 3701)

    Lørenskog, Akershus, Norwaystudy coordinator listed

    Recruiting

  • Akita University Hospital ( Site 2302)

    Akita, Japanstudy coordinator listed

    Recruiting

  • Altru Health System ( Site 0057)

    Grand Forks, North Dakotastudy coordinator listed

    Recruiting

  • Anhui Provincial Cancer Hospital ( Site 2234)

    Hefei, Anhui, Chinastudy coordinator listed

    Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 5114)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Arcispedale Santa Maria Nuova ( Site 4510)

    Reggio Emilia, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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..

What this trial measures

  • Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive SurgeryUp to approximately 30 weeks

    pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

  • Event-Free Survival (EFS)Up to approximately 92 months

    EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.