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

Last updated: September 19, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasms

Treatment

Doxorubicin

Rescue Medication

Capecitabine

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

  • Asociacion Española de Beneficencia ( Site 6403)

    Guatemala City 3598132, 01015
    Guatemala

    Active - Recruiting

  • CELAN,S.A ( Site 6401)

    Guatemala City 3598132, 01010
    Guatemala

    Active - Recruiting

  • INTEGRA Cancer Institute ( Site 6404)

    Guatemala City 3598132, 01010
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 6400)

    Guatemala City 3598132, 01009
    Guatemala

    Active - Recruiting

  • Onco Go, S.A ( Site 6402)

    Guatemala City 3598132, 01010
    Guatemala

    Active - Recruiting

  • Queen Mary Hospital ( Site 1300)

    Pokfulam,
    Hong Kong

    Active - Recruiting

  • Rambam Health Care Campus ( Site 4400)

    Haifa 294801, 3109601
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 4401)

    Ramat Gan 293788, 5265601
    Israel

    Active - Recruiting

  • National Hospital Organization Hokkaido Cancer Center ( Site 2300)

    Sapporo 2128295, Hokkaido 2130037 003-0804
    Japan

    Active - Recruiting

  • The University of Osaka Hospital ( Site 2314)

    Suita 1851483, Osaka 1853904 565-0871
    Japan

    Active - Recruiting

  • Showa Medical University Hospital ( Site 2306)

    Shinagawa, Tokyo 1850144 142-8666
    Japan

    Active - Recruiting

  • Chiba Cancer Center ( Site 2303)

    Chiba 2113015, 260-8717
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital ( Site 2301)

    Fukushima 2112923, 960-1295
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital ( Site 2315)

    Osaka 1853909, 540-0006
    Japan

    Active - Recruiting

  • Seoul National University Bundang Hospital ( Site 1801)

    Kyonggi-do, Kyonggi-do 13620
    South Korea

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 1904)

    Taichung 1668399, 407
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 1900)

    Taipei 1668341, 10048
    Taiwan

    Active - Recruiting

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

    Cherkasy, Cherkaska Oblast 18009
    Ukraine

    Site Not Available

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

    Cherkasy 710791, Cherkasy Oblast 710802 18009
    Ukraine

    Active - Recruiting

  • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 5208)

    Chernivtsi 710719, Chernivetska Oblast 58013
    Ukraine

    Active - Recruiting

  • CNCE Precarpathian Clinical Oncologic Center ( Site 5201)

    Ivano-Frankivsk 707471, Ivano-Frankivsk Oblast 707470 76018
    Ukraine

    Active - Recruiting

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

    Kropyvnytsky, Kirovohrad Oblast 705811 25011
    Ukraine

    Active - Recruiting

  • Saint Joseph Hospital ( Site 0062)

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Bioresearch Partner ( Site 0072)

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Bioresearch Partner ( Site 0072)

    Hialeah 4158476, Florida 4155751 33013
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology ( Site 0084)

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology ( Site 0084)

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Active - Recruiting

  • Franciscan Health ( Site 0077)

    Indianapolis 4259418, Indiana 4921868 46237
    United States

    Active - Recruiting

  • Louisiana State University Health Sciences Shreveport ( Site 0053)

    Shreveport 4341513, Louisiana 4331987 71103
    United States

    Active - Recruiting

  • New England Cancer Specialists ( Site 0051)

    Westbrook, Maine 04092
    United States

    Site Not Available

  • New England Cancer Specialists ( Site 0051)

    Westbrook 4982753, Maine 4971068 04092
    United States

    Active - Recruiting

  • Mercy Medical Center - Baltimore ( Site 0015)

    Baltimore, Maryland 21202
    United States

    Site Not Available

  • Mercy Medical Center - Baltimore ( Site 0015)

    Baltimore 4347778, Maryland 4361885 21202
    United States

    Active - Recruiting

  • Cancer Partners of Nebraska ( Site 0068)

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Cancer Partners of Nebraska ( Site 0068)

    Lincoln 5072006, Nebraska 5073708 68516
    United States

    Active - Recruiting

  • Renown Regional Medical Center ( Site 0041)

    Reno, Nevada 89502
    United States

    Site Not Available

  • Renown Regional Medical Center ( Site 0041)

    Reno 5511077, Nevada 5509151 89502
    United States

    Active - Recruiting

  • Altru Health System ( Site 0057)

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • Altru Health System ( Site 0057)

    Grand Forks 5059429, North Dakota 5690763 58201
    United States

    Active - Recruiting

  • Nashville General Hospital ( Site 0017)

    Nashville, Tennessee 37208
    United States

    Site Not Available

  • Nashville General Hospital ( Site 0017)

    Nashville 4644585, Tennessee 4662168 37208
    United States

    Active - Recruiting

  • Oncology Consultants P.A. ( Site 0073)

    Houston, Texas 77030
    United States

    Site Not Available

  • Oncology Consultants P.A. ( Site 0073)

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Northwest Medical Specialties, PLLC ( Site 0067)

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Northwest Medical Specialties, PLLC ( Site 0067)

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

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