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NCT00462865 · ClinicalTrials.gov registry record · Phase 2
Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse
A Phase 2 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00462865: Clinical Trial Phase 2 study, sponsored by Brown University.
NCT00462865 is a Phase 2 study that was terminated before completion, run by Brown University. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00462865, a Phase 2 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a woman to keep her breast and decreasing the size of the excision for her breast cancer. While current research has shown that survival is the same whether women are treated with chemotherapy first or surgery first for breast cancer, the investigators do not yet know how to treat women with persistent breast cancer after she has received primary chemotherapy. This study looks at the use of a combination regimen of two agents (gemcitabine and capecitabine), both of which are active in breast cancer, and using Avastin to see if this regimen can be given to women treated with primary chemotherapy and then surgery, considered to be at high risk of relapse.
Primary Outcome
6 out of 17 patients came off study for toxicity prior to receiving all treatment. Toxicity issues of administering 6 cycles of gemcitabine, capecitabine, and Avastin and one year of consolidation of Avastin in women with breast cancer previously treated with neoadjuvant chemotherapy that lead to patients being taken off study.
Interventions
- DRUG Gemcitabine and Capecitabine and Avastin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2007-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
Why NCT00462865 stopped before completion
NCT00462865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine and Capecitabine and Avastin is the first listed.
NCT00462865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00462865 about?
NCT00462865 is a clinical study titled "Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse". Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a woman to keep her breast and decreasing the size of the excision for her breast cancer. While current research has sho...
What is the current status of trial NCT00462865?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2007-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00462865?
The interventions under investigation include: Gemcitabine and Capecitabine and Avastin (DRUG).
Who is sponsoring clinical trial NCT00462865?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00462865's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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