A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
NCT ID: NCT07060807
Last Updated: 2025-11-12
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
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2025-07-21
2033-07-14
Brief Summary
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* 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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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
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Eligibility Criteria
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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
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Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Los Angeles Hematology Oncology Medical Group ( Site 0026)
Los Angeles, 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
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
Oncology Consultants P.A. ( Site 0061)
Houston, Texas, United States
Mays Cancer Center ( Site 0049)
San Antonio, Texas, 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
Chongqing Three Gorges Central Hospital's ( Site 3128)
Wanzhou, Chongqing Municipality, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 3118)
Nanning, Guangxi, China
Jiangsu Province Hospital ( Site 3105)
Nanjing, Jiangsu, China
Taizhou Hospital of Zhejiang Province ( Site 3137)
Linhai, Zhejiang, China
Gustave Roussy ( Site 0903)
Villejuif, Val-de-Marne, France
Rambam Health Care Campus ( Site 1401)
Haifa, , 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
National Hospital Organization Hokkaido Cancer Center ( Site 3215)
Sapporo, Hokkaido, Japan
Kindai University Hospital ( Site 3204)
Sayama, Osaka, Japan
National Cancer Center Hospital ( Site 3206)
Chūō, Tokyo, Japan
Showa Medical University Hospital ( Site 3209)
Shinagawa, Tokyo, Japan
Chiba Cancer Center ( Site 3203)
Chiba, , Japan
National Hospital Organization Osaka National Hospital ( Site 3201)
Osaka, , Japan
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
Seoul National University Hospital ( Site 2702)
Jongno-Gu, Seoul, South Korea
Severance Hospital Yonsei University Health System ( Site 2700)
Seoul, , South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1820)
A Coruña, La Coruna, Spain
Hospital Universitario Ramon y Cajal ( Site 1824)
Madrid, , Spain
Hospital Clinico San Carlos... ( Site 1822)
Madrid, , Spain
Taichung Veterans General Hospital ( Site 2803)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2804)
Tainan, , Taiwan
MacKay Memorial Hospital ( Site 2802)
Taipei, , Taiwan
Hacettepe Universite Hastaneleri ( Site 2100)
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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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