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Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
NCT03368729 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Niraparib
Study Locations (7)
Alabama
- University of Alabama at Birmingham — Birmingham
Illinois
- University of Chicago — Chicago
Minnesota
- Mayo Clinic — Rochester
New York
- Montefiore — The Bronx
North Carolina
- University of North Carolina — Chapel Hill
Pennsylvania
- University of Pennsylvania — Philadelphia
Washington
- University of Washington- — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-09-06 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03368729
The ClinicalTrials.gov registry entry for NCT03368729 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03368729 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Alabama, Illinois, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03368729 about?
NCT03368729 is a clinical study titled "Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer". 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) inhi...
What is the current status of trial NCT03368729?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2019-09-06. Estimated completion is 2027-12-30.
What conditions does trial NCT03368729 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2 Positive Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03368729?
The interventions under investigation include: Trastuzumab (DRUG), Niraparib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03368729?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03368729 being conducted?
This trial has 7 study locations across Alabama, Illinois, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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