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

Last updated: November 7, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasms

Treatment

Olaparib

Doxorubicin

Rescue Medication

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: Olaparib
Phase: 3
Study Start date:
June 30, 2025
Estimated Completion Date:
December 29, 2034

Connect with a study center

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)

    Mar del Plata 3430863, Buenos Aires 3435907 B7600FZO
    Argentina

    Active - Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 6005)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1431FWO
    Argentina

    Active - Recruiting

  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000IHE
    Argentina

    Active - Recruiting

  • Sanatorio Allende - Nueva Córdoba ( Site 6000)

    Córdoba 3860259, X5000BFB
    Argentina

    Active - Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 6111)

    Natal 3394023, Rio Grande do Norte 3390290 59062-000
    Brazil

    Active - Recruiting

  • Hospital de Base de São José do Rio Preto ( Site 6101)

    São José do Rio Preto 3448639, São Paulo 3448433 15090-000
    Brazil

    Active - Recruiting

  • CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)

    Québec 6325494, Quebec 6115047 G1S 4L8
    Canada

    Active - Recruiting

  • Anhui Provincial Cancer Hospital ( Site 2234)

    Hefei 1808722, Anhui 1818058 230031
    China

    Active - Recruiting

  • Beijing Cancer Hospital ( Site 2201)

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Active - Recruiting

  • The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2224)

    Xiamen 1790645, Fujian 1811017 361009
    China

    Active - Recruiting

  • Guangdong Maternity and Child Health Care Hospital ( Site 2251)

    Guangzhou 1809858, Guangdong 1809935 511400
    China

    Active - Recruiting

  • Jiangmen Center Hospital ( Site 2243)

    Jiangmen 1806299, Guangdong 1809935 529030
    China

    Active - Recruiting

  • Liuzhou People's Hospital ( Site 2259)

    Liuzhou 1803300, Guangxi 1809867 545006
    China

    Active - Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 2223)

    Nanning 1799869, Guangxi 1809867 530201
    China

    Active - Recruiting

  • Henan Cancer Hospital ( Site 2238)

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Active - Recruiting

  • Wuhan Union Hospital ( Site 2239)

    Wuhan 1791247, Hubei 1806949 430000
    China

    Active - Recruiting

  • Jiangsu Province Hospital ( Site 2216)

    Nanjing 1799962, Jiangsu 1806260 210036
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital ( Site 2217)

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Active - Recruiting

  • The Third Hospital Of Nanchang ( Site 2218)

    Nanchang 1800163, Jiangxi 1806222 330025
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2203)

    Xi'an 1790630, Shaanxi 1796480 710000
    China

    Active - Recruiting

  • Jinan Central Hospital ( Site 2249)

    Jinan 1805753, Shandong 1796328 250013
    China

    Active - Recruiting

  • Shandong Cancer Hospital ( Site 2205)

    Jinan 1805753, Shandong 1796328 250117
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center ( Site 2209)

    Shanghai 1796236, Shanghai Municipality 1796231 200000
    China

    Active - Recruiting

  • Deyang City People's Hospital ( Site 2244)

    Deyang 1812961, Sichuan 1794299 618099
    China

    Active - Recruiting

  • The Second People's Hospital of Neijiang ( Site 2242)

    Neijiang 1799491, Sichuan 1794299 641099
    China

    Active - Recruiting

  • Yunnan Province Cancer Hospital ( Site 2226)

    Kunming 1804651, Yunnan 1785694 650118
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 2212)

    Hangzhou 1808926, Zhejiang 1784764 310017
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital ( Site 2211)

    Hangzhou 1808926, Zhejiang 1784764 310022
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital ( Site 2215)

    Hangzhou 1808926, Zhejiang 1784764 311599
    China

    Active - Recruiting

  • 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

  • Hong Kong United Oncology Centre ( Site 1304)

    Jordan 8224045,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital ( Site 1300)

    Pokfulam,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital ( Site 1301)

    Shatin 1818920,
    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

  • Kanagawa Cancer Center ( Site 2308)

    Yokohama 1848354, Kanagawa 1860291 241-8515
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital ( Site 2317)

    Hirakata 1862540, Osaka 1853904 573-1191
    Japan

    Active - Recruiting

  • The University of Osaka Hospital ( Site 2314)

    Suita 1851483, Osaka 1853904 565-0871
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center ( Site 2309)

    Sunto-gun, Shizuoka 1851715 411-8777
    Japan

    Active - Recruiting

  • Showa Medical University Hospital ( Site 2306)

    Shinagawa, Tokyo 1850144 142-8666
    Japan

    Active - Recruiting

  • Akita University Hospital ( Site 2302)

    Akita 2113126, 010-8543
    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

  • Kyoto University Hospital ( Site 2313)

    Kyoto 1857910, 606-8507
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital ( Site 2315)

    Osaka 1853909, 540-0006
    Japan

    Active - Recruiting

  • National Cancer Centre Singapore ( Site 1700)

    Singapore 1880252, Central Singapore 168583
    Singapore

    Active - Recruiting

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)

    Port Elizabeth 964420, Eastern Cape 1085593 6045
    South Africa

    Active - Recruiting

  • Wits Clinical Research ( Site 4903)

    Johannesburg 993800, Gauteng 1085594 2193
    South Africa

    Active - Recruiting

  • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4901)

    Pretoria 964137, Gauteng 1085594 0181
    South Africa

    Active - Recruiting

  • Sandton Oncology Medical Group (Pty) Ltd ( Site 4900)

    Sandton 957654, Gauteng 1085594 2196
    South Africa

    Active - Recruiting

  • Cancercare Rondebosch Oncology ( Site 4906)

    Cape Town 3369157, Western Cape 1085599 7700
    South Africa

    Active - Recruiting

  • Seoul National University Bundang Hospital ( Site 1801)

    Kyonggi-do, Kyonggi-do 13620
    South Korea

    Active - Recruiting

  • Asan Medical Center ( Site 1803)

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Seoul National University Hospital ( Site 1806)

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System ( Site 1804)

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 1904)

    Taichung 1668399, 407
    Taiwan

    Active - Recruiting

  • MacKay Memorial Hospital ( Site 1903)

    Taipei 1668341, 10449
    Taiwan

    Active - Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 1901)

    Taipei 1668341, 106
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 1900)

    Taipei 1668341, 10048
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 1906)

    Taoyuan District 1667905, 333
    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

  • Shalimov Institute of Surgery and Transplantation ( Site 5210)

    Kyiv 703448, 03126
    Ukraine

    Active - Recruiting

  • St Bartholomew s Hospital ( Site 5302)

    London 2643743, London, City of EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Providence Medical Foundation ( Site 0080)

    Fullerton 5351247, California 5332921 92835
    United States

    Active - Recruiting

  • Saint Joseph Hospital ( Site 0062)

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Intermountain Health St. Mary's Regional Hospital ( Site 0054)

    Grand Junction 5423573, Colorado 5417618 81501
    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

  • Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)

    Cincinnati 4508722, Ohio 5165418 45220
    United States

    Active - Recruiting

  • Avera McKennan Hospital ( Site 0002)

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Active - Recruiting

  • Avera Cancer Institute - Yankton ( Site 0089)

    Yankton 5233053, South Dakota 5769223 57078
    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

  • Hendrick Medical Center ( Site 0009)

    Abilene 4669635, Texas 4736286 79601
    United States

    Active - Recruiting

  • JPS Oncology and Infusion Center ( Site 0083)

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Active - Recruiting

  • Oncology Consultants P.A. ( Site 0073)

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Bon Secours Cancer Institute at St. Francis ( Site 0048)

    Midlothian 4772943, Virginia 6254928 23114
    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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