Title: Multicenter phase II trial of durvalumab (MEDI4736) with trastuzumab and pertuzumab combination in HER2-enriched and HER2-amplified breast cancer (DTP trial)
Principal Investigator: Jenny Chang, MD, of Houston Methodist Cancer Center in Texas
Description: Researchers are conducting a phase 2 study to test the safety and efficacy of durvalumab used in combination with trastuzumab and pertuzumab for HER2-enriched breast cancer.
Patients will receive durvalumab, trastuzumab, and pertuzumab on day 1 every 3 weeks for 6 cycles. Patients will receive trastuzumab at 8 mg/kg for the first dose and then at 6 mg/kg for each subsequent dose. They will receive pertuzumab at 840 mg for the first dose and at 420 mg thereafter. Patients will receive durvalumab at a fixed dose of 1120 mg.
The primary outcome is pathological complete response rate (pCR). Secondary outcomes include pCR by percentage of tumor-infiltrating lymphocytes, pCR by PD-L1 status, 3-year disease-free survival, and treatment-related adverse events.
To be eligible for this study, patients must be 18 years of age or older. They must have a histologically confirmed diagnosis of HER2-enriched and HER2-amplified breast cancer. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by the Methodist Hospital Research Institute in collaboration with AstraZeneca.
ClinicalTrials.gov. Durvalumab with trastuzumab and pertuzumab in HER2-enriched breast cancer (DTP). NCT03820141. Accessed November 22, 2022.