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.
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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.
Status: Recruiting
This study is sponsored by the Methodist Hospital Research Institute in collaboration with AstraZeneca.
Reference
ClinicalTrials.gov. Durvalumab with trastuzumab and pertuzumab in HER2-enriched breast cancer (DTP). NCT03820141. Accessed November 22, 2022.
