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Phase 3Recruiting

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

Sponsored by Merck Sharp & Dohme LLC

About this study

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.

Where this study is enrolling (34)

  • Southern Cancer Center (SCC) ( Site 8000)

    Daphne, Alabama

    Call 251-607-5283

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

    Tucson, Arizona

    Call 520-626-0191

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  • Hoag Memorial Hospital Presbyterian ( Site 0025)

    Newport Beach, California

    Call 949-764-5501

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  • Los Angeles Hematology Oncology Medical Group ( Site 0026)

    Los Angeles, California

    Call 626-627-6666

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

    Grand Junction, Colorado

    Call 970-298-7638

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Show all 34 locations

  • Medical Oncology Hematology Consultants (MOHC) ( Site 8002)

    Newark, Delaware

    Call 302-366-1200

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  • Comprehensive Hematology Oncology ( Site 0060)

    St. Petersburg, Florida

    Call 727-344-6569

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

    Altamonte Springs, Florida

    Call 407-834-5151

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  • Baptist Health Lexington ( Site 0050)

    Lexington, Kentucky

    Call 859-509-3044

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  • Baptist Health Hamburg ( Site 0071)

    Lexington, Kentucky

    Call 859-639-7827

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

    Hackensack, New Jersey

    Call 551-996-5900

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  • Rutgers Cancer Institute of New Jersey ( Site 0033)

    New Brunswick, New Jersey

    Call 732-235-2465

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  • Presbyterian Kaseman Hospital ( Site 0072)

    Albuquerque, New Mexico

    Call 505-925-0405

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  • Presbyterian Rust Jorgensen Cancer ( Site 0073)

    Rio Rancho, New Mexico

    Call 505-253-7878

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  • University of New Mexico Comprehensive Cancer Center ( Site 0047)

    Albuquerque, New Mexico

    Call 505-272-4946

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  • Queens Hospital Cancer Center ( Site 0011)

    Jamaica, New York

    Call 718-883-4133

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  • Optum Medical Care, PC ( Site 0009)

    Westbury, New York

    Call 516-488-2918

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  • Novant Health Oncology Specialists ( Site 0074)

    Winston-Salem, North Carolina

    Call 336-277-8800

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  • Novant Health Cancer Institute ( Site 0019)

    Charlotte, North Carolina

    Call 980-302-6500

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  • TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020)

    Cincinnati, Ohio

    Call 513-865-9460

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  • Cancer Care Associates Of York ( Site 0063)

    York, Pennsylvania

    Call 717-741-9229

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

    Pittsburgh, Pennsylvania

    Call 412-641-6500

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  • Tennessee Oncology ( Site 0068)

    Nashville, Tennessee

    Call 615-320-5090

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  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee

    Call 615-329-7274

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  • Oncology Consultants P.A. ( Site 0061)

    Houston, Texas

    Call 855-827-9525

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  • Mays Cancer Center ( Site 0049)

    San Antonio, Texas

    Call 210-450-3838

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  • JPS Health Network ( Site 0067)

    Fort Worth, Texas

    Call 817-702-8049

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  • Texas Oncology - Central/South Texas ( Site 8005)

    McAllen, Texas

    Call 956-687-5150

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  • Texas Oncology - DFW ( Site 8003)

    Dallas, Texas

    Call 214-370-1794

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  • Texas Oncology - Gulf Coast ( Site 8006)

    Houston, Texas

    Call 832-932-1730

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  • Virginia Oncology Associates (VOA) ( Site 8001)

    Norfolk, Virginia

    Call 757-368-5033

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  • Shenandoah Oncology ( Site 8004)

    Winchester, Virginia

    Call 540-662-1108

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  • Northwest Medical Specialties, PLLC ( Site 0062)

    Tacoma, Washington

    Call 253-841-4296

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

    Madison, Wisconsin

    Call 608-355-2033

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.