OncoMatch/Clinical Trials/NCT07060807
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Is NCT07060807 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for breast neoplasms.
Treatment: Patritumab deruxtecan · Paclitaxel · Nab-paclitaxel · Capecitabine · Liposomal doxorubicin · Trastuzumab deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
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
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 →Frequently asked questions
Is NCT07060807 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, anti-HER3 antibody, antibody-drug conjugate that consists of a topoisomerase I inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ERBB3?
Yes, ERBB3 evaluable is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 deleterious or suspected deleterious germline mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 deleterious or suspected deleterious germline mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages