A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT07060807
Other Study ID Numbers:
1022-016
First Submitted
July 1, 2025
First Posted
July 10, 2025
Last Update Posted
May 14, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Breast Neoplasms
Biological: Patritumab deruxtecanDrug: Paclitaxel

Study Design

Study TypeInterventional
Actual Enrollment1000 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)
Study Start DateJuly 20, 2025
Actual Primary Completion Date7yrs 1mo from now
Actual Study Completion Date7yrs 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Patritumab Deruxtecan
Participants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.
Biological: Patritumab deruxtecan
Administered via intravenous (IV) infusion
Treatment of Physician's Choice
Participants receive treatment of physician's choice (TPC) for up to 13 months. The TPC may be any of the following options: Paclitaxel (80 mg/m\^2) on Days 1, 8, 15, and 22 of each 4-week cycle; Paclitaxel (90 mg/m\^2) on Days 1, 8, and 15 of each 4-week cycle; Nab-paclitaxel (100 mg/m\^2) on Days 1, 8, and 15 of each 4-week cycle; Capecitabine (1000 mg/m\^2) bid on Days 1 to 14 of each 3-week cycle; Liposomal doxorubicin (50 mg/m\^2) on Day 1 of each 4-week cycle; or trastuzumab deruxtecan (T-DXd) (5.4 mg/kg) Q3W.
Drug: Paclitaxel
Administered via IV infusion

Outcome Measures

Primary Outcome Measures
  1. Progression Free Survival (PFS)
    PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by blinded independent central review (BICR). Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
  2. Overall Survival (OS)
    OS is the length of time from when the participant starts treatment until death from any cause.
Secondary Outcome Measures
  1. Objective Response Rate (ORR)
    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.
  2. Duration of Response (DOR)
    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
  3. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score (the standardized average of the raw scores) will be presented.
  4. Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score (the standardized average of the raw scores) will be presented.
  5. Change from Baseline in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better emotional functioning. The change from baseline in EORTC QLQ-C30 Emotional Functioning (Items 21-24) combined score (the standardized average of the raw scores) will be presented.
  6. Change from Baseline in the EORTC-QLQ-C30 Pain (Items 9 and 19) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 2 questions about their pain (Items 9 and 19) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate greater pain. The change from baseline in EORTC QLQ-C30 Pain (Items 9 and 19) combined score (the standardized average of the raw scores) will be presented.
  7. Time to First Deterioration (TTD) in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. The TTD from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score (the standardized average of the raw scores), defined as the time from baseline to the first onset of a 10 or more points deterioration from baseline, will be presented.
  8. TTD in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better physical functioning. The TTD from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score (the standardized average of the raw scores), defined as the time from baseline to the first onset of a 10 or more points deterioration from baseline, will be presented.
  9. TTD in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better emotional functioning. The TTD from baseline in EORTC QLQ-C30 Emotional Functioning (Items 21-24) combined score (the standardized average of the raw scores) defined as the time from baseline to the first onset of a 10 or more points deterioration from baseline, will be presented.
  10. TTD in the EORTC-QLQ-C30 Pain (Items 9 and 19) Combined Score
    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 2 questions about their pain (Items 9 and 19) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate greater pain. The TTD from baseline in EORTC QLQ-C30 Pain (Items 9 and 19) combined score (the standardized average of the raw scores), will be presented.
  11. Number of Participants Who Experience One or More Adverse Event (AEs)
    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.
  12. Number of Participants Who Discontinue Study Treatment Due to an AE
    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent
Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)
Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:
Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or
Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor
Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
Has breast cancer amenable to treatment with curative intent
Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
Has any of the following: a pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has ≥Grade 2 peripheral neuropathy.
Has clinically significant corneal disease
Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening
Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
Southern Cancer Center (SCC) ( Site 8000) | Daphne Alabama, United States, 36526The University of Arizona Cancer Center - North Campus ( Site 0055) | Tucson Arizona, United States, 85719Los Angeles Hematology Oncology Medical Group ( Site 0026) | Los Angeles California, United States, 90017Hoag Memorial Hospital Presbyterian ( Site 0025) | Newport Beach California, United States, 92663St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) | Grand Junction Colorado, United States, 81501Medical Oncology Hematology Consultants (MOHC) ( Site 8002) | Newark Delaware, United States, 19713Comprehensive Hematology Oncology ( Site 0060) | St. Petersburg Florida, United States, 33709Baptist Health Lexington ( Site 0050) | Lexington Kentucky, United States, 40503Baptist Health Hamburg ( Site 0071) | Lexington Kentucky, United States, 40509John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) | Hackensack New Jersey, United States, 07601Rutgers Cancer Institute of New Jersey ( Site 0033) | New Brunswick New Jersey, United States, 08903Presbyterian Kaseman Hospital ( Site 0072) | Albuquerque New Mexico, United States, 87110University of New Mexico Comprehensive Cancer Center ( Site 0047) | Albuquerque New Mexico, United States, 87131Presbyterian Rust Jorgensen Cancer ( Site 0073) | Rio Rancho New Mexico, United States, 87124Queens Hospital Cancer Center ( Site 0011) | Jamaica New York, United States, 11432Optum Medical Care, PC ( Site 0009) | Westbury New York, United States, 11590Novant Health Cancer Institute ( Site 0019) | Charlotte North Carolina, United States, 28204Novant Health Oncology Specialists ( Site 0074) | Winston-Salem North Carolina, United States, 27103TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020) | Cincinnati Ohio, United States, 45220University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058) | Pittsburgh Pennsylvania, United States, 15213Cancer Care Associates Of York ( Site 0063) | York Pennsylvania, United States, 17403SCRI Oncology Partners ( Site 7000) | Nashville Tennessee, United States, 37203Tennessee Oncology, PLLC ( Site 0068) | Nashville Tennessee, United States, 37203Texas Oncology - DFW ( Site 8003) | Dallas Texas, United States, 75246JPS Health Network ( Site 0067) | Fort Worth Texas, United States, 76104Texas Oncology - Gulf Coast ( Site 8006) | Houston Texas, United States, 77024Oncology Consultants P.A. ( Site 0061) | Houston Texas, United States, 77030Texas Oncology - Central/South Texas ( Site 8005) | McAllen Texas, United States, 78503Mays Cancer Center ( Site 0049) | San Antonio Texas, United States, 78229Virginia Oncology Associates (VOA) ( Site 8001) | Norfolk Virginia, United States, 23502Shenandoah Oncology ( Site 8004) | Winchester Virginia, United States, 22601Northwest Medical Specialties, PLLC ( Site 0062) | Tacoma Washington, United States, 98405Circuit Clinical/SSM Health Dean Medical Group ( Site 0039) | Madison Wisconsin, United States, 53715Hospital Aleman ( Site 0200) | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1118AATInstituto de Investigaciones Clínicas Mar del Plata ( Site 0205) | Mar del Plata Buenos Aires, Argentina, B7600FZOFundación Respirar ( Site 0201) | Buenos Aires Buenos Aires F.D., Argentina, C1426AALCentro Privado de RMI Rio Cuarto ( Site 0207) | Río Cuarto Córdoba Province, Argentina, X5800ALBInstituto de Oncología de Rosario ( Site 0208) | Rosario Santa Fe Province, Argentina, S2000KZEInstituto Alexander Fleming ( Site 0202) | CABA , Argentina, C1426DRBHospital Italiano de Córdoba ( Site 0206) | Córdoba , Argentina, X5004BALBlacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 2300) | Blacktown New South Wales, Australia, 2148Chris O'Brien Lifehouse ( Site 2302) | Camperdown New South Wales, Australia, 2050Monash Medical Centre ( Site 2301) | Clayton Victoria, Australia, 3168The Alfred Hospital ( Site 2305) | Melbourne Victoria, Australia, 3004Hospital de Câncer de Recife ( Site 0302) | Recife Pernambuco, Brazil, 50040-000Liga Norte Riograndense Contra o Câncer ( Site 0301) | Natal Rio Grande do Norte, Brazil, 59062-000Hospital do Câncer Mãe de Deus ( Site 0300) | Porto Alegre Rio Grande do Sul, Brazil, 90470-340Instituto de Oncologia Saint Gallen ( Site 0308) | Santa Cruz do Sul Rio Grande do Sul, Brazil, 96830-180ANIMI - Unidade de Tratamento Oncologico ( Site 0306) | Lages Santa Catarina, Brazil, 88501-001Hospital Paulistano ( Site 0304) | São Paulo , Brazil, 01321-001The Moncton Hospital ( Site 0101) | Moncton New Brunswick, Canada, E1C 6Z8Sunnybrook Research Institute ( Site 0105) | Toronto Ontario, Canada, M4N 3M5CIDO SpA ( Site 0408) | Temuco Araucania, Chile, 4810218FALP ( Site 0400) | Santiago Region M. de Santiago, Chile, 7500921Oncovida ( Site 0402) | Santiago Region M. de Santiago, Chile, 7500994Centro de Oncología de Precisión ( Site 0410) | Santiago Region M. de Santiago, Chile, 7560908Clínica MEDS La Dehesa ( Site 0405) | Santiago Region M. de Santiago, Chile, 7691236Bradfordhill ( Site 0401) | Santiago Region M. de Santiago, Chile, 8420383Anhui Provincial Cancer Hospital ( Site 3140) | Hefei Anhui, China, 230088Cancer Hospital Chinese Academy of Medical Sciences ( Site 3100) | Beijing Beijing Municipality, China, 100021Peking University People's Hospital ( Site 3138) | Beijing Beijing Municipality, China, 100044The First Affiliated Hospital of Chongqing Medical University ( Site 3101) | Chongqing Chongqing Municipality, China, 400016Chongqing Three Gorges Central Hospital's ( Site 3128) | Wanzhou Chongqing Municipality, China, 404000The First Affiliated hospital of Xiamen University ( Site 3120) | Fujian Fujian, China, 361003Sun Yat-Sen University Cancer Center ( Site 3102) | Guangzhou Guangdong, China, 510060Jiangmen Center Hospital ( Site 3132) | Jiangmen Guangdong, China, 529000Guangxi Medical University Affiliated Tumor Hospital ( Site 3118) | Nanning Guangxi, China, 530021Henan Cancer Hospital ( Site 3108) | Zhengzhou Henan, China, 450008Xiangyang Central Hospital ( Site 3123) | Xiangyang Hubei, China, 441106Hunan Cancer Hospital ( Site 3134) | Changsha Hunan, China, 410013Jiangsu Cancer Hospital ( Site 3107) | Nanjing Jiangsu, China, 210009Jiangsu Province Hospital ( Site 3105) | Nanjing Jiangsu, China, 210029Nanchang People's Hospital ( Site 3124) | Nanchang Jiangxi, China, 330025Xi'an International Medical Center Hospital ( Site 3122) | Xi'an Shaanxi, China, 710100Affiliated Cancer Hospital of Shandong First Medical University ( Site 3115) | Jinan Shandong, China, 250117Sichuan Cancer Hospital. ( Site 3110) | Chengdu Sichuan, China, 610041West China Hospital of Sichuan University ( Site 3139) | Chengdu Sichuan, China, 610041Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3112) | Ürümqi Xinjiang, China, 830000Sir Run Run Shaw Hospital ( Site 3117) | Hangzhou Zhejiang, China, 310016Zhejiang Cancer Hospital ( Site 3109) | Hangzhou Zhejiang, China, 310022Taizhou Hospital of Zhejiang Province ( Site 3137) | Linhai Zhejiang, China, 317000Instituto de Cancerología-Oncology ( Site 0503) | Medellín Antioquia, Colombia, 050025FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0502) | Bogotá Bogota D.C., Colombia, 110131Instituto Nacional De Cancerologia ( Site 0504) | Bogotá Bogota D.C., Colombia, 111511Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0501) | Valledupar Cesar Department, Colombia, 200001IMAT S.A.S ( Site 0500) | Montería Departamento de Córdoba, Colombia, 230002CHRU de Brest ( Site 0904) | Brest Finistere, France, 29200CENTRE LEON BERARD ( Site 0900) | Lyon Rhone, France, 69008Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0901) | Rouen Seine-Maritime, France, 76038Gustave Roussy ( Site 0903) | Villejuif Val-de-Marne, France, 94800Klinikum Lippe Detmold ( Site 1008) | Detmold North Rhine-Westphalia, Germany, 32756Klinikum Dortmund Klinikzentrum Mitte ( Site 1005) | Dortmund North Rhine-Westphalia, Germany, 44137Universitaetsklinikum des Saarlandes-Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedi ( Site 1003) | Homburg Saarland, Germany, 66424General Hospital of Athens "Laiko" ( Site 1105) | Athens Attica, Greece, 11527Aretaieio Hospital ( Site 1103) | Athens Attica, Greece, 11528University General Hospital of Heraklion ( Site 1102) | Heraklion Irakleio, Greece, 71500European Interbalkan Medical Center-Oncology Department ( Site 1101) | Thessaloniki , Greece, 570 01Prince of Wales Hospital ( Site 3301) | Hong Kong , Hong Kong, Queen Mary Hospital ( Site 3300) | Pokfulam , Hong Kong, Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1200) | Kecskemét Bács-Kiskun county, Hungary, 6000Szabolcs Szatmár Bereg Vármegyei Oktatókórház Oncoradiology ( Site 1203) | Nyíregyháza Szabolcs-Szatmár-Bereg, Hungary, 4400Rambam Health Care Campus ( Site 1401) | Haifa , Israel, 3109601Shaare Zedek Medical Center ( Site 1406) | Jerusalem , Israel, 9103102Hadassah Medical Center ( Site 1404) | Jerusalem , Israel, 9112001Sheba Medical Center ( Site 1400) | Ramat Gan , Israel, 5265601Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1507) | Bergamo Lombardy, Italy, 24127Istituto Europeo di Oncologia IRCCS ( Site 1508) | Milan Lombardy, Italy, 20141Ospedale San Raffaele. ( Site 1502) | Milan , Italy, 20132Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1501) | Milan , Italy, 20133Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1506) | Naples , Italy, 80131Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1500) | Roma , Italy, 00144Aichi Cancer Center ( Site 3200) | Nagoya Aichi-ken, Japan, 464-8681Nagoya City University Hospital ( Site 3210) | Nagoya Aichi-ken, Japan, 467-8602National Hospital Organization Hokkaido Cancer Center ( Site 3215) | Sapporo Hokkaido, Japan, 003-0804Kansai Medical University Hospital ( Site 3213) | Hirakata Osaka, Japan, 573-1191Kindai University Hospital ( Site 3204) | Sakai Osaka, Japan, 590-0197Shizuoka Cancer Center ( Site 3202) | Sunto-gun Shizuoka, Japan, 411-8777National Cancer Center Hospital ( Site 3206) | Chūō Tokyo, Japan, 104-0045Toranomon Hospital ( Site 3205) | Minato Tokyo, Japan, 105-8470Showa Medical University Hospital ( Site 3209) | Shinagawa Tokyo, Japan, 142-8666Akita University Hospital ( Site 3207) | Akita , Japan, 010-8543Chiba Cancer Center ( Site 3203) | Chiba , Japan, 260-8717National Hospital Organization Kyushu Cancer Center ( Site 3208) | Fukuoka , Japan, 811-1395Fukushima Medical University Hospital ( Site 3212) | Fukushima , Japan, 960-1295Hiroshima City Hiroshima Citizens Hospital ( Site 3214) | Hiroshima , Japan, 730-8518National Hospital Organization Osaka National Hospital ( Site 3201) | Osaka , Japan, 540-0006CIO - Centro de Inmuno-Oncología de Occidente ( Site 0600) | Guadalajara Jalisco, Mexico, 44630Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0604) | Monterrey Nuevo León, Mexico, 64460Cuidados Oncologicos. ( Site 0605) | Querétaro City Querétaro, Mexico, 76000Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0602) | Chihuahua City , Mexico, 31123Centro de Investigacion Clinica de Oaxaca ( Site 0601) | Oaxaca City , Mexico, 68020Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0702) | Concepción Departamento de Junín, Peru, 12125Clínica Internacional - Sede San Borja ( Site 0704) | San Borja Lima region, Peru, 15036IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0701) | San Isidro Lima region, Peru, 15036Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1618) | Bydgoszcz Kuyavian-Pomeranian Voivodeship, Poland, 85-796Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1600) | Warsaw Masovian Voivodeship, Poland, 02-781Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1616) | Słupsk Pomeranian Voivodeship, Poland, 76-200Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 1614) | Olsztyn Warmian-Masurian Voivodeship, Poland, 10-228Szpital Wojewodzki im.M.Kopernika. ( Site 1607) | Koszalin West Pomeranian Voivodeship, Poland, 75-581Salve Medica sp. z o.o. sp. k. ( Site 1615) | Lodz Łódź Voivodeship, Poland, 91-211Seoul National University Bundang Hospital ( Site 2703) | Seongnam Kyonggi-do, South Korea, 13620Gangnam Severance Hospital, Yonsei University Health System ( Site 2701) | Gangnam-gu Seoul, South Korea, 06273Samsung Medical Center ( Site 2704) | Gangnam-gu Seoul, South Korea, 06351Seoul National University Hospital ( Site 2702) | Jongno-Gu Seoul, South Korea, 03080Severance Hospital Yonsei University Health System ( Site 2700) | Seoul , South Korea, 03722Asan Medical Center ( Site 2705) | Seoul , South Korea, 05505Institut Català d'Oncologia (ICO) - Badalona ( Site 1823) | Badalona Barcelona, Spain, 08916Hospital Universitario Marques de Valdecilla ( Site 1825) | Santander Cantabria, Spain, 39008CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1820) | A Coruña La Coruna, Spain, 15006Hospital Clinic de Barcelona ( Site 1821) | Barcelona , Spain, 08036Hospital Universitario Ramon y Cajal ( Site 1824) | Madrid , Spain, 28034Hospital Clinico San Carlos... ( Site 1822) | Madrid , Spain, 28040Hospital Universitario Virgen de Valme ( Site 1826) | Seville , Spain, 41014Ditmanson Medical Foundation Chia-Yi Christian Hospital ( Site 2806) | Chiayi City Chiayi, Taiwan, 600Taichung Veterans General Hospital ( Site 2803) | Taichung , Taiwan, 407National Cheng Kung University Hospital ( Site 2804) | Tainan , Taiwan, 704302Chi-Mei Medical Center ( Site 2805) | Tainan , Taiwan, 710National Taiwan University Hospital ( Site 2800) | Taipei , Taiwan, 10048MacKay Memorial Hospital ( Site 2802) | Taipei , Taiwan, 10449National Taiwan University Cancer Center (NTUCC) ( Site 2801) | Taipei , Taiwan, 106Faculty of Medicine Siriraj Hospital ( Site 2921) | Bangkoknoi Bangkok, Thailand, 10700Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2924) | Dusit Bangkok, Thailand, 10300Ramathibodi Hospital. ( Site 2923) | Ratchathewi Bangkok, Thailand, 10400Songklanagarind Hospital ( Site 2922) | Hat Yai Changwat Songkhla, Thailand, 90110Maharaj Nakorn Chiang Mai Hospital ( Site 2925) | Muang Chiang Mai, Thailand, 50200Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2107) | Adana , Turkey (Türkiye), 01120Hacettepe Universite Hastaneleri ( Site 2100) | Ankara , Turkey (Türkiye), 06230Memorial Ankara Hastanesi ( Site 2106) | Ankara , Turkey (Türkiye), 06520Gazi University Health Research and Application Center Gazi Hospital ( Site 2101) | Ankara , Turkey (Türkiye), 06560Ankara Bilkent Şehir Hastanesi ( Site 2105) | Ankara , Turkey (Türkiye), 6800Dicle Üniversitesi ( Site 2102) | Diyarbakır , Turkey (Türkiye), 21280Koç Üniversitesi Hastanesi ( Site 2104) | Istanbul , Turkey (Türkiye), 34010Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 2103) | Mersin , Turkey (Türkiye), 33240Recep Tayyip Erdogan University Training and Research Hospital ( Site 2108) | Rize , Turkey (Türkiye), 53020Samsun Medical Park Hastanesi ( Site 2109) | Samsun , Turkey (Türkiye), 55200St Bartholomew s Hospital ( Site 2200) | London London, City of, United Kingdom, EC1A 7BELeicester Royal Infirmary ( Site 2205) | Leicester , United Kingdom, LE1 5WWThe Christie NHS Foundation Trust ( Site 2208) | Manchester , United Kingdom, M20 4BX
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC