Title: A phase 1b/2 study of the PARP inhibitor niraparib in combination with trastuzumab in patients with metastatic HER2+ breast cancer
Principal Investigator: Erica Stringer-Reasor, MD, of University of Alabama at Birmingham
Description: Researchers are conducting a phase 1b/2 study to test the safety and efficacy of niraparib plus trastuzumab in metastatic HER2-positive breast cancer.
In phase 1, patients in the first arm will receive niraparib at 200 mg on days 1-21 of each 21-day cycle. Patients in the second arm will receive niraparib at 100 mg on days 1-21. Patients in both arms will also receive trastuzumab at 6 mg/kg on day 1.
In phase 2, patients will receive 6 mg/kg of trastuzumab plus 200 mg of niraparib, unless a dose-limiting toxicity occurs in phase 1. In this case, patients will receive 100 mg of niraparib instead of 200 mg.
The primary outcome in phase 1 is dose-limiting toxicity. The primary outcome in phase 2 is the objective response rate. Secondary outcomes include adverse events, progression-free survival, and plasma niraparib levels.
To be eligible for this study, patients must be women who are 18 years of age or older. They must have HER2-positive breast cancer that failed at least 1 anti-HER2 therapy in the metastatic setting. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by University of Alabama at Birmingham in collaboration with Translational Breast Cancer Research Consortium, Tesaro, Inc., Susan G. Komen Breast Cancer Foundation, Breast Cancer Research Foundation of Alabama, and VFoundation.
ClinicalTrials.gov. Niraparib in combination with trastuzumab in metastatic HER2+ breast cancer. NCT03368729. Accessed December 14, 2022.