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

Recruiting now · Phase 3

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT07060807

Run by

Merck Sharp & Dohme LLC

People needed

1000

Starts

2025-07-21

Expected to finish

2033-07-14

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Arizona Cancer Center - North Campus ( Site 0055) — Tucson, Arizona, United States (enrolling)
• Los Angeles Hematology Oncology Medical Group ( Site 0026) — Los Angeles, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian ( Site 0025) — Newport Beach, California, United States (enrolling)
• St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) — Grand Junction, Colorado, United States (enrolling)
• Medical Oncology Hematology Consultants (MOHC) ( Site 8002) — Newark, Delaware, United States (enrolling)
• AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024) — Altamonte Springs, Florida, United States (enrolling)
• Comprehensive Hematology Oncology ( Site 0060) — St. Petersburg, Florida, United States (enrolling)
• Baptist Health Lexington ( Site 0050) — Lexington, Kentucky, United States (enrolling)
• Baptist Health Hamburg ( Site 0071) — Lexington, Kentucky, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001) — Hackensack, New Jersey, United States (enrolling)
• Rutgers Cancer Institute of New Jersey ( Site 0033) — New Brunswick, New Jersey, United States (enrolling)
• Presbyterian Kaseman Hospital ( Site 0072) — Albuquerque, New Mexico, United States (enrolling)
• University of New Mexico Comprehensive Cancer Center ( Site 0047) — Albuquerque, New Mexico, United States (enrolling)
• Presbyterian Rust Jorgensen Cancer ( Site 0073) — Rio Rancho, New Mexico, United States (enrolling)
• Queens Hospital Cancer Center ( Site 0011) — Jamaica, New York, United States (enrolling)
• Optum Medical Care, PC ( Site 0009) — Westbury, New York, United States (enrolling)
• Novant Health Cancer Institute ( Site 0019) — Charlotte, North Carolina, United States (enrolling)
• Novant Health Oncology Specialists ( Site 0074) — Winston-Salem, North Carolina, United States (enrolling)
• TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020) — Cincinnati, Ohio, United States (enrolling)
• University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058) — Pittsburgh, Pennsylvania, United States (enrolling)
• Cancer Care Associates Of York ( Site 0063) — York, Pennsylvania, United States (enrolling)
• SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States (enrolling)
• Tennessee Oncology, PLLC ( Site 0068) — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - DFW ( Site 8003) — Dallas, Texas, United States (enrolling)
• Southern Cancer Center (SCC) ( Site 8000) — Daphne, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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