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NCT03368729 · ClinicalTrials.gov registry record · Phase 1
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
A Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 7
- Study locations
NCT03368729: Active Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma, sponsored by University of Alabama at Birmingham.
NCT03368729 is a Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 46 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03368729, a Phase 1 study of Metastatic Breast Cancer and HER2-Positive Breast Carcinoma, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
A DLT is defined as hematological events \> or equal to grade 3 leukopenia, anemia, and thrombocytopenia and also non-hematological events \> or equal to grade 3 fatigue, nausea, constipation, vomiting, or diarrhea.
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 |
What the registry record for NCT03368729 still lists
NCT03368729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (78% lower).
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.
NCT03368729 lists 7 locations in 7 states (Alabama, Illinois, Minnesota).
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.
What interventions are being tested in trial NCT03368729?
The interventions under investigation include: Trastuzumab (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT03368729?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03368729's enrollment target sits among peer trials
46 85th of 139 higher than 55 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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