A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
NCT ID: NCT07060807
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2025-07-21
2033-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patritumab Deruxtecan
Participants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.
Patritumab deruxtecan
Administered via intravenous (IV) infusion
Treatment of Physician's Choice
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.
Paclitaxel
Administered via IV infusion
Nab-paclitaxel
Administered via IV infusion
Capecitabine
Administered via oral tablets
Liposomal doxorubicin
Administered via IV infusion
Trastuzumab deruxtecan
Administered via IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Patritumab deruxtecan
Administered via intravenous (IV) infusion
Paclitaxel
Administered via IV infusion
Nab-paclitaxel
Administered via IV infusion
Capecitabine
Administered via oral tablets
Liposomal doxorubicin
Administered via IV infusion
Trastuzumab deruxtecan
Administered via IV infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Comprehensive Hematology Oncology ( Site 0060)
St. Petersburg, Florida, United States
Baptist Health Lexington ( Site 0050)
Lexington, Kentucky, 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
Clinical Research Alliance ( Site 0009)
Westbury, New York, 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
JPS Health Network ( Site 0067)
Fort Worth, Texas, United States
Oncology Consultants P.A. ( Site 0061)
Houston, Texas, United States
Mays Cancer Center ( Site 0049)
San Antonio, Texas, 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
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
Hospital Italiano de Córdoba ( Site 0206)
Córdoba, , Argentina
The Moncton Hospital ( Site 0101)
Moncton, New Brunswick, Canada
The First Affiliated Hospital of Chongqing Medical University ( Site 3101)
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital's ( Site 3128)
Wanzhou, Chongqing Municipality, China
Jiangmen Center Hospital ( Site 3132)
Jiangmen, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 3118)
Nanning, Guangxi, China
Jiangsu Province Hospital ( Site 3105)
Nanjing, Jiangsu, China
Nanchang People's Hospital ( Site 3124)
Nanchang, Jiangxi, China
Sichuan Cancer Hospital. ( Site 3110)
Chengdu, Sichuan, China
Taizhou Hospital of Zhejiang Province ( Site 3137)
Linhai, Zhejiang, China
Instituto de Cancerología-Oncology ( Site 0503)
Medellín, Antioquia, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0502)
Bogotá, Bogota D.C., Colombia
Instituto Nacional De Cancerologia ( Site 0504)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0501)
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 0500)
Montería, Departamento de Córdoba, Colombia
CHRU de Brest ( Site 0904)
Brest, Finistere, France
CENTRE LEON BERARD ( Site 0900)
Lyon, Rhone, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0901)
Rouen, Seine-Maritime, France
Gustave Roussy ( Site 0903)
Villejuif, Val-de-Marne, France
Aretaieio Hospital ( Site 1103)
Athens, Attica, Greece
University General Hospital of Heraklion ( Site 1102)
Heraklion, Irakleio, Greece
European Interbalkan Medical Center-Oncology Department ( Site 1101)
Thessaloniki, , Greece
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1200)
Kecskemét, Bács-Kiskun county, Hungary
Rambam Health Care Campus ( Site 1401)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 1406)
Jerusalem, , Israel
Hadassah Medical Center ( Site 1404)
Jerusalem, , Israel
Sheba Medical Center ( Site 1400)
Ramat Gan, , Israel
Istituto Europeo di Oncologia IRCCS ( Site 1508)
Milan, Lombardy, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1506)
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1500)
Roma, , Italy
Nagoya City University Hospital ( Site 3210)
Nagoya, Aichi-ken, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 3215)
Sapporo, Hokkaido, Japan
Kansai Medical University Hospital ( Site 3213)
Hirakata, Osaka, Japan
Kindai University Hospital ( Site 3204)
Sakai, Osaka, Japan
Shizuoka Cancer Center ( Site 3202)
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 3206)
Chūō, Tokyo, Japan
Toranomon Hospital ( Site 3205)
Minato, Tokyo, Japan
Showa Medical University Hospital ( Site 3209)
Shinagawa, Tokyo, Japan
Akita University Hospital ( Site 3207)
Akita, , Japan
Chiba Cancer Center ( Site 3203)
Chiba, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 3208)
Fukuoka, , Japan
Fukushima Medical University Hospital ( Site 3212)
Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3214)
Hiroshima, , Japan
National Hospital Organization Osaka National Hospital ( Site 3201)
Osaka, , Japan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1600)
Warsaw, Masovian Voivodeship, Poland
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 1614)
Olsztyn, Warmian-Masurian Voivodeship, Poland
Seoul National University Bundang Hospital ( Site 2703)
Seongnam, Kyonggi-do, South Korea
Gangnam Severance Hospital, Yonsei University Health System ( Site 2701)
Gangnam-gu, Seoul, South Korea
Samsung Medical Center ( Site 2704)
Gangnam-gu, Seoul, South Korea
Seoul National University Hospital ( Site 2702)
Jongno-Gu, Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 2700)
Seoul, , South Korea
Asan Medical Center ( Site 2705)
Seoul, , South Korea
Hospital Universitario Marques de Valdecilla ( Site 1825)
Santander, Cantabria, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1820)
A Coruña, La Coruna, Spain
Hospital Clinic de Barcelona ( Site 1821)
Barcelona, , Spain
Institut Català d'Oncologia (ICO) - Badalona ( Site 1823)
Barcelona, , Spain
Hospital Universitario Ramon y Cajal ( Site 1824)
Madrid, , Spain
Hospital Clinico San Carlos... ( Site 1822)
Madrid, , Spain
Hospital Universitario Virgen de Valme ( Site 1826)
Seville, , Spain
Ditmanson Medical Foundation Chia-Yi Christian Hospital ( Site 2806)
Chiayi City, Chiayi, Taiwan
Taichung Veterans General Hospital ( Site 2803)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2804)
Tainan, , Taiwan
Chi-Mei Medical Center ( Site 2805)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 2800)
Taipei, , Taiwan
MacKay Memorial Hospital ( Site 2802)
Taipei, , Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 2801)
Taipei, , Taiwan
Hacettepe Universite Hastaneleri ( Site 2100)
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 2106)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 2105)
Ankara, , Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 2104)
Istanbul, , Turkey (Türkiye)
Samsun Medical Park Hastanesi ( Site 2109)
Samsun, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1317-5490
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-520582-51-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031250297
Identifier Type: REGISTRY
Identifier Source: secondary_id
1022-016
Identifier Type: -
Identifier Source: org_study_id