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

NCT07060807 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 1022-016U1111-1317-54902025-520582-51-00jRCT2031250297
• Study Type: interventional
• Target: 1,000
• Locations: 24 countries
• Sites: 168

Brief Summary

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.

• HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
• HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
• Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
• Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 45 months

• Overall Survival (OS)

  OS is the length of time from when the participant starts treatment until death from any cause.

  Up to approximately 85 months

Secondary Outcomes (12)

• Objective Response Rate (ORR)

  Up to approximately 85 months

• Duration of Response (DOR)

  Up to approximately 85 months

• 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

  Baseline and up to approximately 85 months

• Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

  Baseline and up to approximately 85 months

• Change from Baseline in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score

  Baseline and up to approximately 85 months

Study Arms (2)

Patritumab Deruxtecan

EXPERIMENTAL

Participants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.

Biological: Patritumab deruxtecan

Treatment of Physician's Choice

ACTIVE COMPARATOR

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; Drug: Nab-paclitaxel; Drug: Capecitabine; Drug: Liposomal doxorubicin; Biological: Trastuzumab deruxtecan

Interventions

Nab-paclitaxel DRUG

Administered via IV infusion

Also known as: Abraxane®

Treatment of Physician's Choice

Capecitabine DRUG

Administered via oral tablets

Also known as: XELODA®

Treatment of Physician's Choice

Liposomal doxorubicin DRUG

Administered via IV infusion

Also known as: Doxil®

Treatment of Physician's Choice

Trastuzumab deruxtecan BIOLOGICAL

Administered via IV infusion

Also known as: T-DXd, Enhertu®

Treatment of Physician's Choice

Patritumab deruxtecan BIOLOGICAL

Administered via intravenous (IV) infusion

Also known as: MK-1022, HER3-DXd, U3-1402

Patritumab Deruxtecan

Paclitaxel DRUG

Administered via IV infusion

Also known as: TAXOL®, ONXAL®

Treatment of Physician's Choice

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (168)

Southern Cancer Center (SCC) ( Site 8000)

Daphne, Alabama, 36526, United States

RECRUITING

The University of Arizona Cancer Center - North Campus ( Site 0055)

Tucson, Arizona, 85719, United States

RECRUITING

Los Angeles Hematology Oncology Medical Group ( Site 0026)

Los Angeles, California, 90017, United States

RECRUITING

Hoag Memorial Hospital Presbyterian ( Site 0025)

Newport Beach, California, 92663, United States

RECRUITING

St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021)

Grand Junction, Colorado, 81501, United States

RECRUITING

Medical Oncology Hematology Consultants (MOHC) ( Site 8002)

Newark, Delaware, 19713, United States

RECRUITING

Comprehensive Hematology Oncology ( Site 0060)

St. Petersburg, Florida, 33709, United States

RECRUITING

Baptist Health Lexington ( Site 0050)

Lexington, Kentucky, 40503, United States

RECRUITING

Baptist Health Hamburg ( Site 0071)

Lexington, Kentucky, 40509, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0033)

New Brunswick, New Jersey, 08903, United States

RECRUITING

Presbyterian Kaseman Hospital ( Site 0072)

Albuquerque, New Mexico, 87110, United States

RECRUITING

University of New Mexico Comprehensive Cancer Center ( Site 0047)

Albuquerque, New Mexico, 87131, United States

RECRUITING

Presbyterian Rust Jorgensen Cancer ( Site 0073)

Rio Rancho, New Mexico, 87124, United States

RECRUITING

Optum Medical Care, PC ( Site 0009)

Westbury, New York, 11590, United States

RECRUITING

Novant Health Cancer Institute ( Site 0019)

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health Oncology Specialists ( Site 0074)

Winston-Salem, North Carolina, 27103, United States

RECRUITING

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020)

Cincinnati, Ohio, 45220, United States

RECRUITING

University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058)

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Cancer Care Associates Of York ( Site 0063)

York, Pennsylvania, 17403, United States

RECRUITING

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Oncology, PLLC ( Site 0068)

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - DFW ( Site 8003)

Dallas, Texas, 75246, United States

RECRUITING

JPS Health Network ( Site 0067)

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology - Gulf Coast ( Site 8006)

Houston, Texas, 77024, United States

RECRUITING

Oncology Consultants P.A. ( Site 0061)

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Central/South Texas ( Site 8005)

McAllen, Texas, 78503, United States

RECRUITING

Mays Cancer Center ( Site 0049)

San Antonio, Texas, 78229, United States

RECRUITING

Virginia Oncology Associates (VOA) ( Site 8001)

Norfolk, Virginia, 23502, United States

RECRUITING

Shenandoah Oncology ( Site 8004)

Winchester, Virginia, 22601, United States

RECRUITING

Northwest Medical Specialties, PLLC ( Site 0062)

Tacoma, Washington, 98405, United States

RECRUITING

Circuit Clinical/SSM Health Dean Medical Group ( Site 0039)

Madison, Wisconsin, 53715, United States

RECRUITING

Hospital Aleman ( Site 0200)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Fundación Respirar ( Site 0201)

Buenos Aires, Buenos Aires F.D., C1426AAL, Argentina

RECRUITING

Centro Privado de RMI Rio Cuarto ( Site 0207)

Río Cuarto, Córdoba Province, X5800ALB, Argentina

RECRUITING

Instituto de Oncología de Rosario ( Site 0208)

Rosario, Santa Fe Province, S2000KZE, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 0202)

CABA, C1426DRB, Argentina

RECRUITING

Hospital Italiano de Córdoba ( Site 0206)

Córdoba, X5004BAL, Argentina

RECRUITING

Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 2300)

Blacktown, New South Wales, 2148, Australia

RECRUITING

Chris O'Brien Lifehouse ( Site 2302)

Camperdown, New South Wales, 2050, Australia

RECRUITING

Monash Medical Centre ( Site 2301)

Clayton, Victoria, 3168, Australia

RECRUITING

The Alfred Hospital ( Site 2305)

Melbourne, Victoria, 3004, Australia

RECRUITING

Hospital de Câncer de Recife ( Site 0302)

Recife, Pernambuco, 50040-000, Brazil

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 0301)

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

RECRUITING

Hospital do Câncer Mãe de Deus ( Site 0300)

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

RECRUITING

Instituto de Oncologia Saint Gallen ( Site 0308)

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

RECRUITING

ANIMI - Unidade de Tratamento Oncologico ( Site 0306)

Lages, Santa Catarina, 88501-001, Brazil

RECRUITING

Hospital Paulistano ( Site 0304)

São Paulo, 01321-001, Brazil

RECRUITING

The Moncton Hospital ( Site 0101)

Moncton, New Brunswick, E1C 6Z8, Canada

RECRUITING

FALP ( Site 0400)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Oncovida ( Site 0402)

Santiago, Region M. de Santiago, 7500994, Chile

RECRUITING

Centro de Oncología de Precisión ( Site 0410)

Santiago, Region M. de Santiago, 7560908, Chile

RECRUITING

Clínica MEDS La Dehesa ( Site 0405)

Santiago, Region M. de Santiago, 7691236, Chile

RECRUITING

Bradfordhill ( Site 0401)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

CIDO SpA ( Site 0408)

Temuco, Región de la Araucanía, 4810218, Chile

RECRUITING

Anhui Provincial Cancer Hospital ( Site 3140)

Hefei, Anhui, 230088, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3100)

Beijing, Beijing Municipality, 100021, China

ACTIVE NOT RECRUITING

Peking University People's Hospital. ( Site 3138)

Beijing, Beijing Municipality, 100044, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University ( Site 3101)

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Chongqing Three Gorges Central Hospital's ( Site 3128)

Wanzhou, Chongqing Municipality, 404000, China

RECRUITING

The First Affiliated hospital of Xiamen University ( Site 3120)

Fujian, Fujian, 361003, China

RECRUITING

Sun Yat-Sen University Cancer Center ( Site 3102)

Guangzhou, Guangdong, 510060, China

RECRUITING

Jiangmen Center Hospital ( Site 3132)

Jiangmen, Guangdong, 529000, China

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital ( Site 3118)

Nanning, Guangxi, 530021, China

RECRUITING

Henan Cancer Hospital ( Site 3108)

Zhengzhou, Henan, 450008, China

RECRUITING

Xiangyang Central Hospital ( Site 3123)

Xiangyang, Hubei, 441106, China

RECRUITING

Hunan Cancer Hospital ( Site 3134)

Changsha, Hunan, 410013, China

RECRUITING

Jiangsu Cancer Hospital ( Site 3107)

Nanjing, Jiangsu, 210009, China

RECRUITING

Jiangsu Province Hospital ( Site 3105)

Nanjing, Jiangsu, 210029, China

RECRUITING

Nanchang People's Hospital ( Site 3124)

Nanchang, Jiangxi, 330025, China

RECRUITING

Xi'an International Medical Center Hospital ( Site 3122)

Xi'an, Shaanxi, 710100, China

RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University ( Site 3115)

Jinan, Shandong, 250117, China

RECRUITING

Sichuan Cancer Hospital. ( Site 3110)

Chengdu, Sichuan, 610041, China

RECRUITING

West China Hospital of Sichuan University ( Site 3139)

Chengdu, Sichuan, 610041, China

RECRUITING

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3112)

Ürümqi, Xinjiang, 830000, China

RECRUITING

Sir Run Run Shaw Hospital ( Site 3117)

Hangzhou, Zhejiang, 310016, China

RECRUITING

Zhejiang Cancer Hospital ( Site 3109)

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang Province ( Site 3137)

Linhai, Zhejiang, 317000, China

RECRUITING

Instituto de Cancerología-Oncology ( Site 0503)

Medellín, Antioquia, 050025, Colombia

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0502)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Instituto Nacional De Cancerologia ( Site 0504)

Bogotá, Bogota D.C., 111511, Colombia

RECRUITING

Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0501)

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

IMAT S.A.S ( Site 0500)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

CHRU de Brest ( Site 0904)

Brest, Finistere, 29200, France

RECRUITING

CENTRE LEON BERARD ( Site 0900)

Lyon, Rhone, 69008, France

RECRUITING

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0901)

Rouen, Seine-Maritime, 76038, France

RECRUITING

Gustave Roussy ( Site 0903)

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Universitaetsklinikum des Saarlandes-Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedi ( Site 1003)

Homburg, Saarland, 66424, Germany

RECRUITING

General Hospital of Athens "Laiko" ( Site 1105)

Athens, Attica, 11527, Greece

RECRUITING

Aretaieio Hospital ( Site 1103)

Athens, Attica, 11528, Greece

RECRUITING

University General Hospital of Heraklion ( Site 1102)

Heraklion, Irakleio, 71500, Greece

RECRUITING

European Interbalkan Medical Center-Oncology Department ( Site 1101)

Thessaloniki, 570 01, Greece

RECRUITING

Prince of Wales Hospital ( Site 3301)

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital ( Site 3300)

Pokfulam, Hong Kong

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1200)

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

Szabolcs Szatmár Bereg Vármegyei Oktatókórház Oncoradiology ( Site 1203)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

RECRUITING

Rambam Health Care Campus ( Site 1401)

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 1406)

Jerusalem, 9103102, Israel

RECRUITING

Hadassah Medical Center ( Site 1404)

Jerusalem, 9112001, Israel

RECRUITING

Sheba Medical Center ( Site 1400)

Ramat Gan, 5265601, Israel

RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1507)

Bergamo, Lombardy, 24127, Italy

RECRUITING

Istituto Europeo di Oncologia IRCCS ( Site 1508)

Milan, Lombardy, 20141, Italy

RECRUITING

Ospedale San Raffaele. ( Site 1502)

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1501)

Milan, 20133, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1506)

Naples, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1500)

Roma, 00144, Italy

RECRUITING

Aichi Cancer Center ( Site 3200)

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

Nagoya City University Hospital ( Site 3210)

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

National Hospital Organization Hokkaido Cancer Center ( Site 3215)

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Kansai Medical University Hospital ( Site 3213)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Kindai University Hospital ( Site 3204)

Sakai, Osaka, 590-0197, Japan

RECRUITING

Shizuoka Cancer Center ( Site 3202)

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital ( Site 3206)

Chūō, Tokyo, 104-0045, Japan

RECRUITING

Toranomon Hospital ( Site 3205)

Minato, Tokyo, 105-8470, Japan

RECRUITING

Showa Medical University Hospital ( Site 3209)

Shinagawa, Tokyo, 142-8666, Japan

RECRUITING

Akita University Hospital ( Site 3207)

Akita, 010-8543, Japan

RECRUITING

Chiba Cancer Center ( Site 3203)

Chiba, 260-8717, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 3208)

Fukuoka, 811-1395, Japan

RECRUITING

Fukushima Medical University Hospital ( Site 3212)

Fukushima, 960-1295, Japan

RECRUITING

Hiroshima City Hiroshima Citizens Hospital ( Site 3214)

Hiroshima, 730-8518, Japan

RECRUITING

National Hospital Organization Osaka National Hospital ( Site 3201)

Osaka, 540-0006, Japan

RECRUITING

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0600)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0604)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Cuidados Oncologicos. ( Site 0605)

Querétaro City, Querétaro, 76000, Mexico

RECRUITING

Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0602)

Chihuahua City, 31123, Mexico

RECRUITING

Centro de Investigacion Clinica de Oaxaca ( Site 0601)

Oaxaca City, 68020, Mexico

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1600)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1616)

Słupsk, Pomeranian Voivodeship, 76-200, Poland

RECRUITING

Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 1614)

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

RECRUITING

Salve Medica sp. z o.o. sp. k. ( Site 1615)

Lodz, Łódź Voivodeship, 91-211, Poland

RECRUITING

Seoul National University Bundang Hospital ( Site 2703)

Seongnam, Kyonggi-do, 13620, South Korea

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System ( Site 2701)

Gangnam-gu, Seoul, 06273, South Korea

RECRUITING

Samsung Medical Center ( Site 2704)

Gangnam-gu, Seoul, 06351, South Korea

RECRUITING

Seoul National University Hospital ( Site 2702)

Jongno-Gu, Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 2700)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 2705)

Seoul, 05505, South Korea

RECRUITING

Institut Català d'Oncologia (ICO) - Badalona ( Site 1823)

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla ( Site 1825)

Santander, Cantabria, 39008, Spain

RECRUITING

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1820)

A Coruña, La Coruna, 15006, Spain

RECRUITING

Hospital Clinic de Barcelona ( Site 1821)

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Ramon y Cajal ( Site 1824)

Madrid, 28034, Spain

RECRUITING

Hospital Clinico San Carlos... ( Site 1822)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen de Valme ( Site 1826)

Seville, 41014, Spain

RECRUITING

Ditmanson Medical Foundation Chia-Yi Christian Hospital ( Site 2806)

Chiayi City, Chiayi, 600, Taiwan

RECRUITING

Taichung Veterans General Hospital ( Site 2803)

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2804)

Tainan, 704302, Taiwan

RECRUITING

Chi-Mei Medical Center ( Site 2805)

Tainan, 710, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 2800)

Taipei, 10048, Taiwan

RECRUITING

MacKay Memorial Hospital ( Site 2802)

Taipei, 10449, Taiwan

RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 2801)

Taipei, 106, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 2921)

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2924)

Dusit, Bangkok, 10300, Thailand

RECRUITING

Ramathibodi Hospital. ( Site 2923)

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Songklanagarind Hospital ( Site 2922)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 2925)

Muang, Chiang Mai, 50200, Thailand

RECRUITING

Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2107)

Adana, 01120, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri ( Site 2100)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hastanesi ( Site 2106)

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi ( Site 2105)

Ankara, 6800, Turkey (Türkiye)

RECRUITING

Dicle Üniversitesi ( Site 2102)

Diyarbakır, 21280, Turkey (Türkiye)

RECRUITING

Koç Üniversitesi Hastanesi ( Site 2104)

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 2103)

Mersin, 33240, Turkey (Türkiye)

RECRUITING

Recep Tayyip Erdogan University Training and Research Hospital ( Site 2108)

Rize, 53020, Turkey (Türkiye)

RECRUITING

Samsun Medical Park Hastanesi ( Site 2109)

Samsun, 55200, Turkey (Türkiye)

RECRUITING

St Bartholomew s Hospital ( Site 2200)

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

RECRUITING

Leicester Royal Infirmary ( Site 2205)

Leicester, LE1 5WW, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 2208)

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary Link

MeSH Terms

Conditions

Breast Neoplasms

Interventions

patritumab deruxtecan; Paclitaxel; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Capecitabine; liposomal doxorubicin; trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; 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: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): July 14, 2033
• Study Completion (Estimated): July 14, 2033
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (4); TH (5); FR (4); CN (23); TU (9); GR (4); BR (6); CA (1); CL (6); HU (2); GB (3); HK (2); CO (5); IT (6); JP (15); AU (4); ME (5); KR (6); IL (4); AR (7); US (32); TW (7); DE (1); ES (7)