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OncoMatch/Clinical Trials/NCT07060807

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

Is NCT07060807 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast neoplasms.

Phase 3RecruitingMerck Sharp & Dohme LLCNCT07060807Data as of May 2026

Treatment: Patritumab deruxtecan · Paclitaxel · Nab-paclitaxel · Capecitabine · Liposomal doxorubicin · Trastuzumab deruxtecanResearchers 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 positive

Has centrally-confirmed HR+ and HER2- results

Required: HER2 (ERBB2) negative

Has centrally-confirmed HR+ and HER2- results

Required: ERBB3 evaluable

human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy

Excluded: BRCA1 deleterious or suspected deleterious germline mutation

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

Excluded: BRCA2 deleterious or suspected deleterious germline mutation

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

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: CDK4/6 inhibitor + endocrine therapy — advanced or adjuvant

Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET)

Cannot have received: chemotherapy

Exception: for unresectable locally advanced or metastatic breast cancer

Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer

Cannot have received: anti-HER3 antibody

Has received prior treatment with an anti-HER3 antibody

Cannot have received: antibody-drug conjugate that consists of a topoisomerase I inhibitor (T-DXd)

Has received prior treatment with ... antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy

Cannot have received: topoisomerase I inhibitor

Has received prior treatment with ... any other topoisomerase I inhibitor therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Southern Cancer Center (SCC) ( Site 8000) · Daphne, Alabama
  • Los Angeles Hematology Oncology Medical Group ( Site 0026) · Los Angeles, California
  • Hoag Memorial Hospital Presbyterian ( Site 0025) · Newport Beach, California
  • St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021) · Grand Junction, Colorado
  • Medical Oncology Hematology Consultants (MOHC) ( Site 8002) · Newark, Delaware

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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