Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HER2 Positive Breast Carcinoma
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: There are two phases to this study. Phase 1 will enroll 6-12 patients and Phase 2 will enroll up to 40. Trastuzumab will be given intravenously at 6 mg/kg on Day 1 for each 21 day cycle in both phases. Niraparib will be given by mouth every day at a dosage of 200 mg for phase 1 participants and 200 mg (or 100 mg) for phase 2 participants. Tumor measurement and response will be monitored by MRI or CT scans after cycles 3 and 6 and then every 12 weeks for up to 2 years or until disease progression. Blood and tissue samples will be collected for pharmacokinetics, biomarkers, and laboratory evaluations.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Treatment will be administered on an outpatient basis. All patients in the phase 1 and 2 portion of the study will receive Niraparib by mouth on days 1-21 of each 21 day cycle as well as trastuzumab intravenously (IV) on day 1 of each cycle. Blood and tissue will be collected at pre-specified times ...
Treatment will be administered on an outpatient basis. All patients in the phase 1 and 2 portion of the study will receive Niraparib by mouth on days 1-21 of each 21 day cycle as well as trastuzumab intravenously (IV) on day 1 of each cycle. Blood and tissue will be collected at pre-specified times to enable pharmacokinetic, biomarker, and toxicity studies. The drug dosage will then be determined for the phase 2 portion at a dose limiting level. Following treatment, patients will be followed every 6 weeks for 6 months until disease progression or an unacceptable adverse event.
Tracking Information
- NCT #
- NCT03368729
- Collaborators
- Translational Breast Cancer Research Consortium
- Tesaro, Inc.
- Susan G. Komen Breast Cancer Foundation
- Breast Cancer Research Foundation of Alabama
- VFoundation
- Investigators
- Principal Investigator: Erica Stringer-Reasor, M.D. University of Alabama at Birmingham
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