drugset / Trial / NCT03368729
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
Phase 1/2
Active not recruiting
46 enrolled
University of Alabama at Birmingham
Breast Cancer Research Foundation of Alabama · collabSusan G. Komen Breast Cancer Foundation · collabTesaro, Inc. · collabThe V Foundation · collabTranslational Breast Cancer Research Consortium · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2019-09-06
- Primary completion
- 2027-11-01
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 100 mg | Oral |
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |