RecruitingPhase 3NCT07060807

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,000 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing patritumab deruxtecan (a targeted antibody-drug designed to find and kill cancer cells with high HER3 protein expression) in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer that has stopped responding to prior treatments. **You may be eligible if...** - You have been diagnosed with hormone receptor-positive (HR+), HER2-negative breast cancer - Your cancer is locally advanced (not operable) or has spread to other parts of the body (metastatic) - You have received prior endocrine (hormone) therapy and CDK4/6 inhibitor treatment - You have received at least one but no more than two prior lines of chemotherapy for metastatic disease - You are in good overall health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your cancer is HER2-positive - You have not received prior endocrine therapy for advanced disease - You have active brain metastases that are untreated - You have significant lung, heart, or nerve problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPatritumab deruxtecan

Administered via intravenous (IV) infusion

DRUGPaclitaxel

Administered via IV infusion

DRUGNab-paclitaxel

Administered via IV infusion

DRUGCapecitabine

Administered via oral tablets

DRUGLiposomal doxorubicin

Administered via IV infusion

BIOLOGICALTrastuzumab deruxtecan

Administered via IV infusion

Locations(174)

Southern Cancer Center (SCC) ( Site 8000)

Daphne, Alabama, United States

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

Tucson, Arizona, United States

Los Angeles Hematology Oncology Medical Group ( Site 0026)

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian ( Site 0025)

Newport Beach, California, United States

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

Grand Junction, Colorado, United States

Medical Oncology Hematology Consultants (MOHC) ( Site 8002)

Newark, Delaware, United States

Comprehensive Hematology Oncology ( Site 0060)

St. Petersburg, Florida, United States

Baptist Health Lexington ( Site 0050)

Lexington, Kentucky, United States

Baptist Health Hamburg ( Site 0071)

Lexington, Kentucky, United States

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

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 0033)

New Brunswick, New Jersey, United States

Presbyterian Kaseman Hospital ( Site 0072)

Albuquerque, New Mexico, United States

University of New Mexico Comprehensive Cancer Center ( Site 0047)

Albuquerque, New Mexico, United States

Presbyterian Rust Jorgensen Cancer ( Site 0073)

Rio Rancho, New Mexico, United States

Queens Hospital Cancer Center ( Site 0011)

Jamaica, New York, United States

Optum Medical Care, PC ( Site 0009)

Westbury, New York, United States

Novant Health Cancer Institute ( Site 0019)

Charlotte, North Carolina, United States

Novant Health Oncology Specialists ( Site 0074)

Winston-Salem, North Carolina, United States

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020)

Cincinnati, Ohio, United States

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

Pittsburgh, Pennsylvania, United States

Cancer Care Associates Of York ( Site 0063)

York, Pennsylvania, United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

Tennessee Oncology, PLLC ( Site 0068)

Nashville, Tennessee, United States

Texas Oncology - DFW ( Site 8003)

Dallas, Texas, United States

JPS Health Network ( Site 0067)

Fort Worth, Texas, United States

Texas Oncology - Gulf Coast ( Site 8006)

Houston, Texas, United States

Oncology Consultants P.A. ( Site 0061)

Houston, Texas, United States

Texas Oncology - Central/South Texas ( Site 8005)

McAllen, Texas, United States

Mays Cancer Center ( Site 0049)

San Antonio, Texas, United States

Virginia Oncology Associates (VOA) ( Site 8001)

Norfolk, Virginia, United States

Shenandoah Oncology ( Site 8004)

Winchester, Virginia, United States

Northwest Medical Specialties, PLLC ( Site 0062)

Tacoma, Washington, United States

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

Madison, Wisconsin, United States

Hospital Aleman ( Site 0200)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

Mar del Plata, Buenos Aires, Argentina

Fundación Respirar ( Site 0201)

Buenos Aires, Buenos Aires F.D., Argentina

Centro Privado de RMI Rio Cuarto ( Site 0207)

Río Cuarto, Córdoba Province, Argentina

Instituto de Oncología de Rosario ( Site 0208)

Rosario, Santa Fe Province, Argentina

Instituto Alexander Fleming ( Site 0202)

CABA, Argentina

Hospital Italiano de Córdoba ( Site 0206)

Córdoba, Argentina

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

Blacktown, New South Wales, Australia

Chris O'Brien Lifehouse ( Site 2302)

Camperdown, New South Wales, Australia

Monash Medical Centre ( Site 2301)

Clayton, Victoria, Australia

The Alfred Hospital ( Site 2305)

Melbourne, Victoria, Australia

Hospital de Câncer de Recife ( Site 0302)

Recife, Pernambuco, Brazil

Liga Norte Riograndense Contra o Câncer ( Site 0301)

Natal, Rio Grande do Norte, Brazil

Hospital do Câncer Mãe de Deus ( Site 0300)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0308)

Santa Cruz do Sul, Rio Grande do Sul, Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0306)

Lages, Santa Catarina, Brazil

Hospital Paulistano ( Site 0304)

São Paulo, Brazil

The Moncton Hospital ( Site 0101)

Moncton, New Brunswick, Canada

CIDO SpA ( Site 0408)

Temuco, Araucania, Chile

FALP ( Site 0400)