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Clinical Trial Summary

The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer. This study will evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03368729
Study type Interventional
Source University of Alabama at Birmingham
Contact Erica Stringer-Reasor, M.D.
Phone 205-975-2816
Email strinem@uab.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date September 6, 2019
Completion date December 30, 2024

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