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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

2026-11-03

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

Pegylated liposomal doxorubicin

Administered via IV infusion

BIOLOGICAL

Trastuzumab deruxtecan

Administered via IV infusion

DRUG

Rescue Medication

Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications include: 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

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 time of diagnosis of locally advanced unresectable or metastatic breast cancer. A new biopsy obtained after progression of the most recent line of therapy is preferred * 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) interstitial lung disease (ILD) or pneumonitis irrespective of steroid use, or has current ILD or suspected ILD, or ILD 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 (206)

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

AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024)

Altamonte Springs, Florida, 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

Cancer Care Specialists ( Site 9503)

Reno, Nevada, 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 ( 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

Sir Charles Gairdner Hospital ( Site 2304)

Nedlands, Western Australia, 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

Sunnybrook Research Institute ( Site 0105)

Toronto, Ontario, Canada

Princess Margaret Cancer Center ( Site 0116)

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0113)

Montreal, Quebec, Canada

Saskatoon Cancer Centre ( Site 0106)

Saskatoon, Saskatchewan, Canada

CIDO SpA ( Site 0408)

Temuco, Araucania, Chile

Fundación Arturo López Pérez ( Site 0400)