A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
NCT ID: NCT06966700
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2400 participants
INTERVENTIONAL
2025-06-30
2034-12-29
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sac-TMT
Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.
Sacituzumab tirumotecan
IV infusion
Pembrolizumab
IV infusion
Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
Carboplatin
IV infusion
Paclitaxel
IV infusion
Doxorubicin
IV infusion
Epirubicin
IV infusion
Cyclophosphamide
IV infusion
Capecitabine
Oral tablet
Olaparib
Oral tablet
Chemotherapy
Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.
Pembrolizumab
IV infusion
Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
Carboplatin
IV infusion
Paclitaxel
IV infusion
Doxorubicin
IV infusion
Epirubicin
IV infusion
Cyclophosphamide
IV infusion
Capecitabine
Oral tablet
Olaparib
Oral tablet
Interventions
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Sacituzumab tirumotecan
IV infusion
Pembrolizumab
IV infusion
Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
Carboplatin
IV infusion
Paclitaxel
IV infusion
Doxorubicin
IV infusion
Epirubicin
IV infusion
Cyclophosphamide
IV infusion
Capecitabine
Oral tablet
Olaparib
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 treatment randomization.
* Demonstrates adequate organ function.
Exclusion Criteria
* 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 randomization.
* 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 or has current pneumonitis/interstitial lung disease.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Providence Medical Foundation ( Site 0080)
Fullerton, California, United States
Saint Joseph Hospital ( Site 0062)
Denver, Colorado, United States
Intermountain Health St. Mary's Regional Hospital ( Site 0054)
Grand Junction, Colorado, United States
Bioresearch Partner ( Site 0072)
Hialeah, Florida, United States
Fort Wayne Medical Oncology and Hematology ( Site 0084)
Fort Wayne, Indiana, United States
Franciscan Health ( Site 0077)
Indianapolis, Indiana, United States
Louisiana State University Health Sciences Shreveport ( Site 0053)
Shreveport, Louisiana, United States
New England Cancer Specialists ( Site 0051)
Westbrook, Maine, United States
Mercy Medical Center - Baltimore ( Site 0015)
Baltimore, Maryland, United States
Cancer Partners of Nebraska ( Site 0068)
Lincoln, Nebraska, United States
Renown Regional Medical Center ( Site 0041)
Reno, Nevada, United States
Altru Health System ( Site 0057)
Grand Forks, North Dakota, United States
Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)
Cincinnati, Ohio, United States
Avera McKennan Hospital ( Site 0002)
Sioux Falls, South Dakota, United States
Avera Cancer Institute - Yankton ( Site 0089)
Yankton, South Dakota, United States
Nashville General Hospital ( Site 0017)
Nashville, Tennessee, United States
Hendrick Medical Center ( Site 0009)
Abilene, Texas, United States
JPS Oncology and Infusion Center ( Site 0083)
Fort Worth, Texas, United States
Oncology Consultants P.A. ( Site 0073)
Houston, Texas, United States
Bon Secours Cancer Institute at St. Francis ( Site 0048)
Midlothian, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington, United States
Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)
Mar del Plata, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 6005)
Buenos Aires, Buenos Aires F.D., Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio Allende - Nueva Córdoba ( Site 6000)
Córdoba, , Argentina
Liga Norte Riograndense Contra o Câncer ( Site 6111)
Natal, Rio Grande do Norte, Brazil
Hospital de Base de São José do Rio Preto ( Site 6101)
São José do Rio Preto, São Paulo, Brazil
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)
Québec, Quebec, Canada
Anhui Provincial Cancer Hospital ( Site 2234)
Hefei, Anhui, China
Beijing Cancer Hospital ( Site 2201)
Beijing, Beijing Municipality, China
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2224)
Xiamen, Fujian, China
Guangdong Maternity and Child Health Care Hospital ( Site 2251)
Guangzhou, Guangdong, China
Jiangmen Center Hospital ( Site 2243)
Jiangmen, Guangdong, China
Liuzhou People's Hospital ( Site 2259)
Liuzhou, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 2223)
Nanning, Guangxi, China
Henan Cancer Hospital ( Site 2238)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 2239)
Wuhan, Hubei, China
Nanjing Drum Tower Hospital ( Site 2217)
Nanjing, Jiangsu, China
Jiangsu Province Hospital ( Site 2216)
Nanjing, Jiangsu, China
The Third Hospital Of Nanchang ( Site 2218)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2203)
Xi'an, Shaanxi, China
Jinan Central Hospital ( Site 2249)
Jinan, Shandong, China
Shandong Cancer Hospital ( Site 2205)
Jinan, Shandong, China
Fudan University Shanghai Cancer Center ( Site 2209)
Shanghai, Shanghai Municipality, China
Deyang City People's Hospital ( Site 2244)
Deyang, Sichuan, China
The Second People's Hospital of Neijiang ( Site 2242)
Neijiang, Sichuan, China
Yunnan Province Cancer Hospital ( Site 2226)
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 2212)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2211)
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital ( Site 2215)
Hangzhou, Zhejiang, China
MEDI-K ( Site 6400)
Guatemala City, , Guatemala
CELAN,S.A ( Site 6401)
Guatemala City, , Guatemala
INTEGRA Cancer Institute ( Site 6404)
Guatemala City, , Guatemala
Onco Go, S.A ( Site 6402)
Guatemala City, , Guatemala
Asociacion Española de Beneficencia ( Site 6403)
Guatemala City, , Guatemala
Hong Kong United Oncology Centre ( Site 1304)
Jordan, , Hong Kong
Queen Mary Hospital ( Site 1300)
Pokfulam, , Hong Kong
Prince of Wales Hospital ( Site 1301)
Shatin, , Hong Kong
Rambam Health Care Campus ( Site 4400)
Haifa, , Israel
Sheba Medical Center ( Site 4401)
Ramat Gan, , Israel
National Hospital Organization Hokkaido Cancer Center ( Site 2300)
Sapporo, Hokkaido, Japan
Kanagawa Cancer Center ( Site 2308)
Yokohama, Kanagawa, Japan
Kansai Medical University Hospital ( Site 2317)
Hirakata, Osaka, Japan
The University of Osaka Hospital ( Site 2314)
Suita, Osaka, Japan
Shizuoka Cancer Center ( Site 2309)
Sunto-gun, Shizuoka, Japan
Showa Medical University Hospital ( Site 2306)
Shinagawa, Tokyo, Japan
Akita University Hospital ( Site 2302)
Akita, , Japan
Chiba Cancer Center ( Site 2303)
Chiba, , Japan
Fukushima Medical University Hospital ( Site 2301)
Fukushima, , Japan
Kyoto University Hospital ( Site 2313)
Kyoto, , Japan
National Hospital Organization Osaka National Hospital ( Site 2315)
Osaka, , Japan
National Cancer Centre Singapore ( Site 1700)
Singapore, Central Singapore, Singapore
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)
Port Elizabeth, Eastern Cape, South Africa
Wits Clinical Research ( Site 4903)
Johannesburg, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4901)
Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd ( Site 4900)
Sandton, Gauteng, South Africa
Cancercare Rondebosch Oncology ( Site 4906)
Cape Town, Western Cape, South Africa
Seoul National University Bundang Hospital ( Site 1801)
Kyonggi-do, Kyonggi-do, South Korea
Seoul National University Hospital ( Site 1806)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 1804)
Seoul, , South Korea
Asan Medical Center ( Site 1803)
Seoul, , South Korea
Taichung Veterans General Hospital ( Site 1904)
Taichung, , Taiwan
National Taiwan University Hospital ( Site 1900)
Taipei, , Taiwan
MacKay Memorial Hospital ( Site 1903)
Taipei, , Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 1901)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 1906)
Taoyuan District, , Taiwan
COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)
Cherkasy, Cherkasy Oblast, Ukraine
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 5208)
Chernivtsi, Chernivetska Oblast, Ukraine
CNCE Precarpathian Clinical Oncologic Center ( Site 5201)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
CNE Regional clinical oncology center of Kirovograd regional Council ( Site 5203)
Kropyvnytsky, Kirovohrad Oblast, Ukraine
Shalimov Institute of Surgery and Transplantation ( Site 5210)
Kyiv, , Ukraine
St Bartholomew s Hospital ( Site 5302)
London, London, City of, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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U1111-1316-7898
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-520190-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031250231
Identifier Type: REGISTRY
Identifier Source: secondary_id
2870-032
Identifier Type: -
Identifier Source: org_study_id