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NCT01305941 · ClinicalTrials.gov registry record · Phase 2
A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01305941 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 32 participants.
The verdict
NCT01305941, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Purpose: This study is a single-arm, open-label phase II clinical trial testing the hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective, safe, and tolerable among patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will come off study. Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized to the brain.
Interventions
- DRUG Trastuzumab
- DRUG Everolimus
- DRUG Vinorelbine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-10-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01305941
The ClinicalTrials.gov registry entry for NCT01305941 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01305941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01305941 about?
NCT01305941 is a clinical study titled "A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases". Purpose: This study is a single-arm, open-label phase II clinical trial testing the hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective, safe, and tolerable among patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metasta...
What is the current status of trial NCT01305941?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2011-09. Estimated completion is 2017-10-16.
What interventions are being tested in trial NCT01305941?
The interventions under investigation include: Trastuzumab (DRUG), Everolimus (DRUG), Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT01305941?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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