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NCT00464646 · ClinicalTrials.gov registry record · Phase 2
Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer
A Phase 2 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT00464646: Completed Phase 2 study, sponsored by NSABP Foundation.
NCT00464646 is a Phase 2 study that has completed, run by NSABP Foundation. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00464646, a Phase 2 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: * How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors * Side effects from adding bevacizumab to chemotherapy and trastuzumab * Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery
Primary Outcome
The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.
Interventions
- DRUG Trastuzumab
- DRUG Cyclophosphamide
- DRUG Bevacizumab
- DRUG Docetaxel
- DRUG Epirubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2007-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT00464646 record still lists
NCT00464646 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT00464646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00464646 about?
NCT00464646 is a clinical study titled "Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer". The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: * How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect b...
What is the current status of trial NCT00464646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2007-05. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00464646?
The interventions under investigation include: Trastuzumab (DRUG), Cyclophosphamide (DRUG), Bevacizumab (DRUG), Docetaxel (DRUG), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT00464646?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00464646's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 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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