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

NCT06966700 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 2870-032U1111-1316-78982024-520190-12-00jRCT2031250231
• Study Type: interventional
• Target: 2,400
• Locations: 37 countries
• Sites: 265

Brief 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

Conditions

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

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery

  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.

  Up to approximately 30 weeks

• Event-Free Survival (EFS)

  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.

  Up to approximately 92 months

Secondary Outcomes (13)

• Overall Survival (OS)

  Up to approximately 115 months

• Percentage of Participants with pCR with No Ductal Carcinoma in Situ (pCR-no DCIS) at the Time of Definitive Surgery

  Up to approximately 30 weeks

• Percentage of Participants with pCR at the Time of Definitive Surgery (High-risk, early-stage, TNBC subset)

  Up to approximately 30 weeks

• Event-Free Survival (EFS) (High-risk, early-stage, TNBC subset)

  Up to approximately 92 months

• Overall Survival (OS) (High-risk, early-stage, TNBC subset)

  Up to approximately 115 months

Study Arms (2)

sac-TMT

EXPERIMENTAL

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.

Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Rescue Medication; Drug: Carboplatin; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Olaparib

Chemotherapy

ACTIVE COMPARATOR

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.

Biological: Pembrolizumab; Drug: Rescue Medication; Drug: Carboplatin; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Olaparib

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, Keytruda®

Chemotherapy; sac-TMT

Capecitabine DRUG

Oral tablet

Also known as: Xeloda®

Chemotherapy; sac-TMT

Doxorubicin DRUG

IV infusion

Also known as: ADRIAMYCIN®

Chemotherapy; sac-TMT

Epirubicin DRUG

IV infusion

Also known as: Ellence®

Chemotherapy; sac-TMT

Sacituzumab tirumotecan BIOLOGICAL

IV infusion

Also known as: Sac-TMT, MK-2870

sac-TMT

Rescue Medication DRUG

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).

Chemotherapy; sac-TMT

Carboplatin DRUG

IV infusion

Also known as: Paraplatin

Chemotherapy; sac-TMT

Paclitaxel DRUG

IV infusion

Also known as: Taxol, Onxol

Chemotherapy; sac-TMT

Cyclophosphamide DRUG

IV infusion

Also known as: Cytophosphane

Chemotherapy; sac-TMT

Olaparib DRUG

Oral tablet

Also known as: LYNPARZA®

Chemotherapy; sac-TMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 treatment randomization.
• Demonstrates adequate organ function.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (265)

Banner MD Anderson Cancer Center ( Site 0066)

Gilbert, Arizona, 85234, United States

RECRUITING

Mayo Clinic Cancer Center ( Site 0034)

Phoenix, Arizona, 85054, United States

RECRUITING

University of Arizona Cancer Center ( Site 0035)

Tucson, Arizona, 85719, United States

RECRUITING

Roy and Patricia Disney Family Cancer Center ( Site 0055)

Burbank, California, 91505, United States

RECRUITING

Providence Medical Foundation ( Site 0080)

Fullerton, California, 92835, United States

RECRUITING

Hoag Memorial Hospital Presbyterian ( Site 0010)

Newport Beach, California, 92663, United States

RECRUITING

Helios Clinical Research ( Site 0061)

Whittier, California, 90602, United States

RECRUITING

Intermountain Health Cancer Center Saint Joseph ( Site 0062)

Denver, Colorado, 80218, United States

RECRUITING

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

Grand Junction, Colorado, 81501, United States

RECRUITING

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

Altamonte Springs, Florida, 32701, United States

RECRUITING

Florida Cancer Specialists - South ( Site 7004)

Fort Myers, Florida, 33901, United States

RECRUITING

Bioresearch Partner ( Site 0072)

Hialeah, Florida, 33013, United States

RECRUITING

Mayo Clinic Hospital ( Site 0013)

Jacksonville, Florida, 32224, United States

RECRUITING

Florida Cancer Specialists - North ( Site 7002)

St. Petersburg, Florida, 33701, United States

RECRUITING

Fort Wayne Medical Oncology and Hematology ( Site 0084)

Fort Wayne, Indiana, 46804, United States

RECRUITING

Franciscan Health ( Site 0077)

Indianapolis, Indiana, 46237, United States

RECRUITING

Ochsner Clinic Foundation ( Site 0021)

New Orleans, Louisiana, 70121, United States

RECRUITING

Louisiana State University Health Sciences Shreveport ( Site 0053)

Shreveport, Louisiana, 71103, United States

RECRUITING

New England Cancer Specialists ( Site 0051)

Westbrook, Maine, 04092, United States

RECRUITING

Mercy Medical Center - Baltimore ( Site 0015)

Baltimore, Maryland, 21202, United States

RECRUITING

Saint Luke's Cancer Institute ( Site 0059)

Kansas City, Missouri, 64111, United States

RECRUITING

Washington University Siteman Cancer Center ( Site 0031)

St Louis, Missouri, 63110, United States

RECRUITING

Cancer Partners of Nebraska ( Site 0068)

Lincoln, Nebraska, 68516, United States

RECRUITING

Optum Care Cancer Center ( Site 0050)

Las Vegas, Nevada, 89102, United States

RECRUITING

Renown Regional Medical Center ( Site 0041)

Reno, Nevada, 89502, United States

RECRUITING

Hackensack Univ Medical Center (HUMC) ( Site 0007)

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0076)

New Brunswick, New Jersey, 08901, United States

RECRUITING

Altru Health System ( Site 0057)

Grand Forks, North Dakota, 58201, United States

RECRUITING

Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)

Cincinnati, Ohio, 45220, United States

RECRUITING

Medical University of South Carolina-Hollings Cancer Center ( Site 0016)

Charleston, South Carolina, 29425, United States

RECRUITING

St Francis Cancer Center ( Site 0093)

Greenville, South Carolina, 29607, United States

RECRUITING

Avera McKennan Hospital ( Site 0002)

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Avera Cancer Institute - Yankton ( Site 0089)

Yankton, South Dakota, 57078, United States

RECRUITING

Tennessee Cancer Specialists ( Site 7001)

Knoxville, Tennessee, 37909, United States

RECRUITING

Nashville General Hospital ( Site 0017)

Nashville, Tennessee, 37208, United States

RECRUITING

Vanderbilt-Ingram Cancer Center ( Site 0038)

Nashville, Tennessee, 37232, United States

RECRUITING

Hendrick Medical Center ( Site 0009)

Abilene, Texas, 79601, United States

RECRUITING

JPS Oncology and Infusion Center ( Site 0083)

Fort Worth, Texas, 76104, United States

RECRUITING

Kelsey-Seybold Clinic ( Site 0042)

Houston, Texas, 77025, United States

RECRUITING

Kelsey-Seybold Clinic ( Site 0088)

Houston, Texas, 77025, United States

RECRUITING

Oncology Consultants P.A. ( Site 0073)

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - San Antonio ( Site 8004)

San Antonio, Texas, 78240, United States

RECRUITING

Intermountain Medical Center ( Site 0074)

Murray, Utah, 84107, United States

RECRUITING

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

Midlothian, Virginia, 23114, United States

RECRUITING

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005)

Roanoke, Virginia, 24014, United States

RECRUITING

Fred Hutchinson Cancer Center ( Site 0069)

Seattle, Washington, 98109, United States

RECRUITING

Cancer Care Northwest ( Site 0003)

Spokane, Washington, 99202, United States

RECRUITING

Northwest Medical Specialties, PLLC ( Site 0067)

Tacoma, Washington, 98405, United States

RECRUITING

University of Wisconsin-Madison ( Site 0024)

Madison, Wisconsin, 53792, United States

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Hospital Italiano de Buenos Aires-ginecology ( Site 6003)

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

RECRUITING

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

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

RECRUITING

Fundacion Ars Medica ( Site 6004)

San Salvador de Jujuy, Jujuy Province, Y4600EHA, Argentina

RECRUITING

Sanatorio Parque ( Site 6002)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

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

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

RECRUITING

Sanatorio Finochietto ( Site 6007)

Buenos Aires, C1187AAN, Argentina

RECRUITING

Sanatorio Allende - Nueva Córdoba ( Site 6000)

Córdoba, X5000BFB, Argentina

RECRUITING

Sanatorio de la Cañada - Córdoba ( Site 6001)

Córdoba, X5000BSQ, Argentina

RECRUITING

Chris O'Brien Lifehouse ( Site 1206)

Camperdown, New South Wales, 2050, Australia

RECRUITING

Macquarie University ( Site 1203)

North Ryde, New South Wales, 2109, Australia

RECRUITING

Monash Health ( Site 1201)

Clayton, Victoria, 3168, Australia

RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 3204)

Liège, Liege, 4000, Belgium

RECRUITING

Jessa Ziekenhuis ( Site 3200)

Hasselt, Limburg, 3500, Belgium

RECRUITING

AZORG Campus Aalst-Moorselbaan ( Site 3201)

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

UZ Gent ( Site 3202)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

CHU UCL Namur/Site Sainte Elisabeth ( Site 3203)

Namur, 5000, Belgium

RECRUITING

PRONUTRIR ( Site 6120)

Fortaleza, Ceará, 60810-180, Brazil

RECRUITING

Hospital Araújo Jorge ( Site 6100)

Goiânia, Goiás, 74605-070, Brazil

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 6111)

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

RECRUITING

Associação Hospitalar Beneficente São Vicente de Paulo ( Site 6115)

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 6102)

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

Hospital São Lucas da PUCRS ( Site 6103)

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Clínica de Oncologia Reichow ( Site 6112)

Blumenau, Santa Catarina, 89010-340, Brazil

RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 6108)

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

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

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

RECRUITING

INCA Hospital do Câncer III ( Site 6107)

Rio de Janeiro, 20560-120, Brazil

RECRUITING

NL Health Services ( Site 0232)

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

Royal Victoria Regional Health Centre ( Site 0233)

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

Health Sciences North ( Site 0234)

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

Lakeridge Health ( Site 0225)

Oshawa, Ontario, L1G 2B9, Canada

RECRUITING

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0209)

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sault Area Hospital ( Site 0226)

Sault Ste. Marie, Ontario, P6B 0A8, Canada

RECRUITING

Princess Margaret Cancer Centre ( Site 0208)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal ( Site 0201)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital ( Site 0200)

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

McGill University Health Centre ( Site 0202)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

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

Québec, Quebec, G1S 4L8, Canada

RECRUITING

CIUSSS de l'Estrie-CHUS ( Site 0206)

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Centro de Estudios Clínicos SAGA ( Site 6205)

Santiago, Region M. de Santiago, 7500653, Chile

RECRUITING

FALP ( Site 6200)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Bradfordhill ( Site 6202)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

ONCOCENTRO APYS ( Site 6204)

Viña del Mar, Región de Valparaíso, 2520598, Chile

RECRUITING

Anhui Provincial Cancer Hospital ( Site 2234)

Hefei, Anhui, 230031, China

RECRUITING

Beijing Cancer Hospital ( Site 2201)

Beijing, Beijing Municipality, 100142, China

RECRUITING

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

Xiamen, Fujian, 361009, China

RECRUITING

Guangdong Maternity and Child Health Care Hospital ( Site 2251)

Guangzhou, Guangdong, 511400, China

RECRUITING

Jiangmen Center Hospital ( Site 2243)

Jiangmen, Guangdong, 529030, China

RECRUITING

Liuzhou People's Hospital ( Site 2259)

Liuchow, Guangxi, 545006, China

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital ( Site 2223)

Nanning, Guangxi, 530201, China

RECRUITING

Harbin Medical University Cancer Hospital ( Site 2204)

Haerbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital ( Site 2238)

Zhengzhou, Henan, 450000, China

RECRUITING

Wuhan Union Hospital ( Site 2239)

Wuhan, Hubei, 430000, China

RECRUITING

Renmin Hospital of Wuhan University ( Site 2236)

Wuhan, Hubei, 430060, China

RECRUITING

Xiangya Hospital of Central South University ( Site 2225)

Changsha, Hunan, 410008, China

RECRUITING

Nanjing Drum Tower Hospital ( Site 2217)

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital ( Site 2216)

Nanjing, Jiangsu, 210036, China

RECRUITING

The Third Hospital Of Nanchang ( Site 2218)

Nanchang, Jiangxi, 330025, China

RECRUITING

The First Hospital Of Jilin University ( Site 2207)

Changchun, Jilin, 130021, China

RECRUITING

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

Xi'an, Shaanxi, 710000, China

RECRUITING

Jinan Central Hospital ( Site 2249)

Jinan, Shandong, 250013, China

RECRUITING

Shandong Cancer Hospital ( Site 2205)

Jinan, Shandong, 250117, China

RECRUITING

LinYi Cancer Hospital ( Site 2248)

Linyi, Shandong, 276034, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 2209)

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Deyang City People's Hospital ( Site 2244)

Deyang, Sichuan, 618099, China

RECRUITING

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

Neijiang, Sichuan, 641099, China

RECRUITING

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2230)

Ürümqi, Xinjiang, 830000, China

RECRUITING

Yunnan Province Cancer Hospital ( Site 2226)

Kunming, Yunnan, 650118, China

RECRUITING

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

Hangzhou, Zhejiang, 310017, China

RECRUITING

Zhejiang Cancer Hospital ( Site 2211)

Hangzhou, Zhejiang, 310022, China

ACTIVE NOT RECRUITING

Zhejiang Provincial People's Hospital ( Site 2215)

Hangzhou, Zhejiang, 311599, China

RECRUITING

Instituto de Cancerología-Oncology ( Site 6302)

Medellín, Antioquia, 050025, Colombia

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 6311)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6309)

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

IMAT S.A.S ( Site 6300)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Oncologos del Occidente ( Site 6303)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fundación Valle del Lili ( Site 6308)

Cali, Valle del Cauca Department, 760036, Colombia

RECRUITING

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 3400)

Brno, Brno-mesto, 656 53, Czechia

RECRUITING

Oulun yliopistollinen sairaala ( Site 3603)

Oulu, North Ostrobothnia, 90220, Finland

RECRUITING

Tampereen ylipistollinen sairaala ( Site 3601)

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 3600)

Helsinki, Uusimaa, 00029, Finland

RECRUITING

Institut Paoli Calmettes. ( Site 3906)

Marseille, Bouches-du-Rhone, 13009, France

RECRUITING

Centre Georges Francois Leclerc ( Site 3902)

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

Centre de Cancerologie du Grand Montpellier ( Site 3910)

Montpellier, Herault, 34070, France

RECRUITING

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 3900)

Rennes, Ille-et-Vilaine, 35000, France

RECRUITING

CHU d'Amiens-Picardie - Hôpital Sud ( Site 3908)

Amiens, Somme, 80054, France

RECRUITING

HENRI MONDOR HOSPITAL ( Site 3904)

Créteil, Val-de-Marne, 94010, France

RECRUITING

Institut Curie ( Site 3903)

Paris, 75248, France

RECRUITING

InVO Institut für Versorgungsforschung in der Onkologie ( Site 4009)

Koblenz, Rhineland-Palatinate, 56068, Germany

RECRUITING

CaritasKlinikum Saarbruecken St. Theresia ( Site 4014)

Saarbrücken, Saarland, 66113, Germany

RECRUITING

Helios Klinikum Berlin-Buch ( Site 4008)

Berlin, 13125, Germany

RECRUITING

General Hospital of Athens - Laiko ( Site 4104)

Athens, Attica, 115 27, Greece

RECRUITING

Aretaieio Hospital Oncology Unit ( Site 4101)

Athens, Attica, 115 28, Greece

RECRUITING

Metropolitan Hospital ( Site 4102)

Athens, Attica, 185 47, Greece

RECRUITING

ATHENS MEDICAL CENTER ( Site 4100)

Marousi, Attica, 151 25, Greece

RECRUITING

European Interbalkan Medical Center ( Site 4103)

Thessaloniki, 570 01, Greece

RECRUITING

MEDI-K ( Site 6400)

Guatemala City, 01009, Guatemala

RECRUITING

CELAN,S.A ( Site 6401)

Guatemala City, 01010, Guatemala

RECRUITING

INTEGRA Cancer Institute ( Site 6404)

Guatemala City, 01010, Guatemala

RECRUITING

Onco Go, S.A ( Site 6402)

Guatemala City, 01010, Guatemala

RECRUITING

Asociacion Española de Beneficencia ( Site 6403)

Guatemala City, 01015, Guatemala

RECRUITING

Hong Kong United Oncology Centre ( Site 1304)

Jordan, Hong Kong

RECRUITING

Queen Mary Hospital ( Site 1300)

Pokfulam, Hong Kong

RECRUITING

Prince of Wales Hospital ( Site 1301)

Shatin, Hong Kong

RECRUITING

Tuen Mun Hospital ( Site 1303)

Tuenmen, Hong Kong

RECRUITING

Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4208)

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 4207)

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 4202)

Szeged, Csongrád megye, 6720, Hungary

RECRUITING

Rambam Health Care Campus ( Site 4400)

Haifa, 3109601, Israel

RECRUITING

Meir Medical Center. ( Site 4403)

Kfar Saba, 4428164, Israel

RECRUITING

Sheba Medical Center ( Site 4401)

Ramat Gan, 5265601, Israel

RECRUITING

Yitzhak Shamir Medical Center. ( Site 4404)

Ẕerifin, 70300, Israel

RECRUITING

Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno ( Site 4503)

Livorno, Tuscany, 57124, Italy

RECRUITING

Azienda Ospedaliero Universitaria delle Marche ( Site 4509)

Ancona, 60126, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4501)

Milan, 20133, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana ( Site 4506)

Pisa, 56126, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena ( Site 4512)

Roma, 00144, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 4500)

Roma, 00168, Italy

RECRUITING

Nagoya City University Hospital ( Site 2310)

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center ( Site 2319)

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

National Hospital Organization Hokkaido Cancer Center ( Site 2300)

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Kanazawa Medical University Hospital ( Site 2321)

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

RECRUITING

Kanagawa Cancer Center ( Site 2308)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Mie University Hospital ( Site 2312)

Tsu, Mie-ken, 514-8507, Japan

RECRUITING

Naha Nishi Clinic ( Site 2320)

Naha, Okinawa, 901-0154, Japan

RECRUITING

Kansai Medical University Hospital ( Site 2317)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Kindai University Hospital ( Site 2316)

Sakai, Osaka, 590-0197, Japan

RECRUITING

The University of Osaka Hospital ( Site 2314)

Suita, Osaka, 565-0871, Japan

RECRUITING

Shizuoka Cancer Center ( Site 2309)

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital ( Site 2305)

Chūō, Tokyo, 104-0045, Japan

RECRUITING

Toranomon Hospital ( Site 2307)

Minato, Tokyo, 105-8470, Japan

RECRUITING

Showa Medical University Hospital ( Site 2306)

Shinagawa, Tokyo, 142-8666, Japan

RECRUITING

Akita University Hospital ( Site 2302)

Akita, 010-8543, Japan

RECRUITING

Chiba Cancer Center ( Site 2303)

Chiba, 260-8717, Japan

RECRUITING

Fukushima Medical University Hospital ( Site 2301)

Fukushima, 960-1295, Japan

RECRUITING

Hiroshima City Hiroshima Citizens Hospital ( Site 2318)

Hiroshima, 730-8518, Japan

RECRUITING

Kumamoto Shinto General Hospital ( Site 2322)

Kumamoto, 862-8655, Japan

RECRUITING

Kyoto University Hospital ( Site 2313)

Kyoto, 606-8507, Japan

RECRUITING

Nakagami Hospital ( Site 2323)

Okinawa, 904-2195, Japan

RECRUITING

National Hospital Organization Osaka National Hospital ( Site 2315)

Osaka, 540-0006, Japan

RECRUITING

University Malaya Medical Centre. ( Site 1503)

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Pulau Pinang ( Site 1502)

George Town, Pulau Pinang, 10450, Malaysia

RECRUITING

National Cancer Institute ( Site 1501)

Putrajaya, Putrajaya, 62250, Malaysia

RECRUITING

Sarawak General Hospital ( Site 1504)

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Pantai Hospital Kuala Lumpur ( Site 1500)

Kuala Lumpur, 59100, Malaysia

RECRUITING

Auckland City Hospital ( Site 1000)

Auckland, 1023, New Zealand

RECRUITING

Akershus Universitetssykehus ( Site 3701)

Lørenskog, Akershus, 1474, Norway

RECRUITING

Drammen Sykehus, Vestre Viken HF ( Site 3700)

Drammen, Buskerud, 3004, Norway

RECRUITING

Nordlandssykehuset ( Site 3704)

Bodø, Nordland, 8005, Norway

RECRUITING

Stavanger Universitetssjukehus ( Site 3702)

Stavanger, Rogaland, 4011, Norway

RECRUITING

Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 6605)

Concepción, Departamento de Junín, 12125, Peru

RECRUITING

Instituto Regional de Enfermedades Neoplásicas Del Norte ( Site 6606)

Trujillo, La Libertad, 13001, Peru

RECRUITING

Hospital Guillermo Almenara Irigoyen ( Site 6601)

Lima, 15001, Peru

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 6600)

Lima, 15036, Peru

RECRUITING

Oncosalud ( Site 6603)

Lima, 15036, Peru

RECRUITING

THE MEDICAL CITY ( Site 1602)

Pasig, National Capital Region, 1605, Philippines

RECRUITING

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 4616)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 4612)

Krakow, Lesser Poland Voivodeship, 31-115, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 4609)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 4608)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 4600)

Słupsk, Pomeranian Voivodeship, 76-200, Poland

RECRUITING

Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 4614)

Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

RECRUITING

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 4611)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

RECRUITING

Salve Medica sp. z o.o. sp. k. ( Site 4618)

Lodz, Łódź Voivodeship, 91-211, Poland

RECRUITING

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 4619)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

RECRUITING

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4702)

Lisbon, Lisbon District, 1449-005, Portugal

RECRUITING

Hospital de Cascais Doutor José de Almeida ( Site 4700)

Lisbon, 2755-009, Portugal

RECRUITING

Instituto Portugues de Oncologia do Porto ( Site 4705)

Porto, 4200-072, Portugal

RECRUITING

Spitalul Clinic Filantropia ( Site 4801)

Bucharest, 011132, Romania

RECRUITING

Institutul Oncologic Cluj ( Site 4802)

Cluj-Napoca, 400015, Romania

RECRUITING

National Cancer Centre Singapore ( Site 1700)

Singapore, Central Singapore, 168583, Singapore

RECRUITING

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)

Port Elizabeth, Eastern Cape, 6045, South Africa

RECRUITING

Wits Clinical Research ( Site 4903)

Johannesburg, Gauteng, 2193, South Africa

RECRUITING

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4901)

Pretoria, Gauteng, 0181, South Africa

RECRUITING

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

Sandton, Gauteng, 2196, South Africa

RECRUITING

Cancercare Rondebosch Oncology ( Site 4906)

Cape Town, Western Cape, 7700, South Africa

RECRUITING

National Cancer Center ( Site 1800)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

Seoul National University Bundang Hospital ( Site 1801)

Kyonggi-do, Kyonggi-do, 13620, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital ( Site 1805)

Taegu, Taegu-Kwangyokshi, 41404, South Korea

RECRUITING

Seoul National University Hospital ( Site 1806)

Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 1804)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 1803)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 1807)

Seoul, 06351, South Korea

RECRUITING

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1802)

Seoul, 06591, South Korea

RECRUITING

Institut Català d'Oncologia - L'Hospitalet ( Site 5001)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital de Basurto ( Site 5007)

Bilbao, Bizkaia, 48013, Spain

RECRUITING

Complejo asistencial universitario de Salamanca ( Site 5000)

Salamanca, Castille and León, 37007, Spain

RECRUITING

HOSPITAL UNIVERSITARIO DE JAEN ( Site 5003)

Jaén, Jaen, 23007, Spain

RECRUITING

CHUS - Hospital Clinico Universitario ( Site 5006)

Santiago de Compostela, La Coruna, 15706, Spain

RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 5004)

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital General de Valencia ( Site 5008)

Valencia, Valenciana, Comunitat, 46014, Spain

RECRUITING

Parc de Salut Mar - Hospital del Mar ( Site 5005)

Barcelona, 08003, Spain

RECRUITING

Hospital Beata María Ana ( Site 5010)

Madrid, +34914097423, Spain

RECRUITING

Hospital Universitario Virgen Macarena ( Site 5002)

Seville, 41009, Spain

RECRUITING

Skånes Universitetssjukhus Malmö ( Site 3802)

Malmo, Skåne County, 20502, Sweden

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 3800)

Stockholm, Stockholm County, 171 64, Sweden

RECRUITING

Akademiska sjukhuset ( Site 3801)

Uppsala, Uppsala County, 751 85, Sweden

RECRUITING

Södra Älvsborgs Sjukhus Borås ( Site 3804)

Borås, Västra Götaland County, 501 82, Sweden

RECRUITING

Taichung Veterans General Hospital ( Site 1904)

Taichung, 407, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 1900)

Taipei, 10048, Taiwan

RECRUITING

MacKay Memorial Hospital ( Site 1903)

Taipei, 10449, Taiwan

RECRUITING

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

Taipei, 106, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch ( Site 1906)

Taoyuan District, 33305, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 2000)

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Chulalongkorn University ( Site 2001)

Pathumwan, Bangkok, 10330, Thailand

RECRUITING

Songklanagarind Hospital ( Site 2002)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 2003)

Muang, Chiang Mai, 50200, Thailand

RECRUITING

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

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

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

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

RECRUITING

CNCE Precarpathian Clinical Oncologic Center ( Site 5201)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

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

Kropyvnytsky, Kirovohrad Oblast, 25011, Ukraine

RECRUITING

Shalimov Institute of Surgery and Transplantation ( Site 5210)

Kyiv, 03126, Ukraine

RECRUITING

Ninewells Hospital and Medical School ( Site 5300)

Dundee, Dundee City, DD2 1SG, United Kingdom

RECRUITING

Huddersfield Royal Infirmary ( Site 5313)

Huddersfield, England, HD3 3EA, United Kingdom

RECRUITING

Princess Royal University Hospital ( Site 5316)

Orpington, Kent, BR6 8ND, United Kingdom

RECRUITING

St Bartholomew s Hospital ( Site 5302)

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

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Carboplatin; Paclitaxel; Doxorubicin; Epirubicin; Cyclophosphamide; Capecitabine; olaparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): March 23, 2033
• Study Completion (Estimated): December 29, 2034
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

NO (4); CN (28); IT (6); CA (12); NZ (1); DE (3); CO (6); PH (1); BR (10); AU (3); ZA (5); AR (9); PT (3); HK (4); IL (4); TH (4); BE (5); PL (9); US (49); KR (8); JP (22); SE (4); PE (5); TW (5); UA (5); GR (5); HU (3); GB (4); CL (4); CZ (1); FI (3); SG (1); RO (2); ES (10); GU (5); MY (5); FR (7)