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

Last updated: August 14, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasms

Treatment

Doxorubicin

Rescue Medication

Epirubicin

Clinical Study ID

NCT06966700
2870-032
2024-520190-12-00
jRCT2031250231
U1111-1316-7898
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for new ways to treat types of breast cancer that are both:

  • High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment

  • Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.

Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.

The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:

  • Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy

  • Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Eligibility Criteria

Inclusion

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 lymphnode (N) staging per AJCC 8th edition criteria as assessed by the investigator basedon 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 istriple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expressionin 1% to 10% cells and HER2-), as by the most recent American Society of ClinicalOncology (ASCO)/College of American Pathologists (CAP) guidelines.

  • Provides a core needle biopsy from the primary breast tumor at screening to thecentral laboratory.

  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performedwithin 28 days before treatment randomization.

  • Demonstrates adequate organ function.

Exclusion

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/ordefinitive surgery for currently diagnosed breast cancer

  • Has undergone excisional biopsy of the primary tumor, axillary lymph nodedissection, and/or axillary sentinel lymph node biopsy prior to study treatment.

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before randomization.

  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or withan 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 ofstudy intervention.

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 5 years.

  • Uncontrolled systemic disease.

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.

Study Design

Total Participants: 2400
Treatment Group(s): 10
Primary Treatment: Doxorubicin
Phase: 3
Study Start date:
June 30, 2025
Estimated Completion Date:
February 04, 2035

Connect with a study center

  • COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)

    Cherkasy, Cherkaska Oblast 18009
    Ukraine

    Active - Recruiting

  • CNE Regional clinical oncology center of Kirovograd regional Council ( Site 5203)

    Kropyvnytsky, Kirovohradska Oblast 25011
    Ukraine

    Active - Recruiting

  • Bioresearch Partner ( Site 0072)

    Hialeah, Florida 33013
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology ( Site 0084)

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • New England Cancer Specialists ( Site 0051)

    Westbrook, Maine 04092
    United States

    Active - Recruiting

  • Mercy Medical Center - Baltimore ( Site 0015)

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Cancer Partners of Nebraska ( Site 0068)

    Lincoln, Nebraska 68516
    United States

    Active - Recruiting

  • Renown Regional Medical Center ( Site 0041)

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Altru Health System ( Site 0057)

    Grand Forks, North Dakota 58201
    United States

    Active - Recruiting

  • Nashville General Hospital ( Site 0017)

    Nashville, Tennessee 37208
    United States

    Active - Recruiting

  • Oncology Consultants P.A. ( Site 0073)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Northwest Medical Specialties, PLLC ( Site 0067)

    Tacoma, Washington 98405
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.