An 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).
An 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).
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.
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.
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:
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:
Trialsites@msd.com1-888-577-8839
Daphne, Alabama 36526, United States
251-607-5283
Tucson, Arizona 85719, United States
Los Angeles, California 90017, United States
Newport Beach, California 92663, United States
Grand Junction, Colorado 81501, United States
Newark, Delaware 19713, United States
Altamonte Springs, Florida 32701, United States
St. Petersburg, Florida 33709, United States
Hackensack, New Jersey 07601, United States
New Brunswick, New Jersey 08903, United States
Albuquerque, New Mexico 87131, United States
Rio Rancho, New Mexico 87124, United States
Winston-Salem, North Carolina 27103, United States
Cincinnati, Ohio 45220, United States
Pittsburgh, Pennsylvania 15213, United States
Madison, Wisconsin 53715, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT, Argentina
+541148277000X2306
Mar del Plata, Buenos Aires B7600FZO, Argentina
Río Cuarto, Córdoba Province X5800ALB, Argentina
Rosario, Santa Fe Province S2000KZE, Argentina
CABA, C1426DRB, Argentina
+541132218900
Blacktown, New South Wales 2148, Australia
Natal, Rio Grande do Norte 59062-000, Brazil
Porto Alegre, Rio Grande do Sul 90470-340, Brazil
Santa Cruz do Sul, Rio Grande do Sul 96830-180, Brazil
Lages, Santa Catarina 88501-001, Brazil
Montreal, Quebec H2X 3E4, Canada
Santiago, Region M. de Santiago 7560908, Chile
Beijing, Beijing Municipality 100021, China
Beijing, Beijing Municipality 100044, China
Chongqing, Chongqing Municipality 400016, China
Wanzhou, Chongqing Municipality 404000, China
Fujian, Fujian 361003, China
0592-2137327
Nanning, Guangxi 530021, China
Jinan, Shandong 250117, China
Ürümqi, Xinjiang 830000, China
Bogotá, Bogota D.C. 110131, Colombia
Valledupar, Cesar Department 200001, Colombia
Rouen, Seine-Maritime 76038, France
Dortmund, North Rhine-Westphalia 44137, Germany
Trier, Rhineland-Palatinate 54290, Germany
Homburg, Saarland 66424, Germany
Thessaloniki, 570 01, Greece
Pokfulam, Hong Kong
39103339
Kecskemét, Bács-Kiskun county 6000, Hungary
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Budapest, 1088, Hungary
Budapest, 1122, Hungary
Bergamo, Lombardy 24127, Italy
Milan, 20133, Italy
Naples, 80131, Italy
Roma, 00144, Italy
Matsuyama, Ehime 791-0280, Japan
Sapporo, Hokkaido 003-0804, Japan
Hidaka, Saitama 350-1298, Japan
Sunto-gun, Shizuoka 411-8777, Japan
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Shinagawa, Tokyo 142-8666, Japan
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Kagoshima, 892-0833, Japan
Guadalajara, Jalisco 44630, Mexico
Monterrey, Nuevo León 64460, Mexico
Chihuahua City, 31123, Mexico
Concepción, Departamento de Junín 12125, Peru
San Isidro, Lima region 15036, Peru
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Bialystok, Podlaskie Voivodeship 15-027, Poland
Słupsk, Pomeranian Voivodeship 76-200, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-228, Poland
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Seongnam, Kyonggi-do 13620, South Korea
Gangnam-gu, Seoul 06273, South Korea
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Gangnam-gu, Seoul 06351, South Korea
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A Coruña, La Coruna 15006, Spain
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Ankara, 06560, Turkey (Türkiye)
Rize, 53020, Turkey (Türkiye)
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