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RECRUITING

NCT07060807

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-07-21

Completion Date

2033-07-14

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Breast Neoplasms

Interventions

BIOLOGICAL

Patritumab deruxtecan

Administered via intravenous (IV) infusion

DRUG

Paclitaxel

Administered via IV infusion

DRUG

Nab-paclitaxel

Administered via IV infusion

DRUG

Capecitabine

Administered via oral tablets

DRUG

Liposomal doxorubicin

Administered via IV infusion

BIOLOGICAL

Trastuzumab deruxtecan

Administered via IV infusion

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

Locations (159)

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

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

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

Monash Medical Centre ( Site 2301)

Clayton, Victoria, Australia

The Alfred Hospital ( Site 2305)

Melbourne, Victoria, Australia

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

FALP ( Site 0400)