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NCT00925652 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00925652: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00925652 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00925652, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
If residual breast cancer is found in the breast or lymph node tissue removed after preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the future. The purpose of this research study is to determine if having additional treatment after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy would make a difference in reducing the participants chance of breast cancer recurrence compared to the standard of care, which is observation alone. This study will also evaluate the potential additional benefits from participating in an exercise and dietary intervention compared to the dietary intervention alone. Because no one knows which which post-neoadjuvant strategy is best, participants will be "randomized" to one of the study groups: 1. Diet Intervention arm, 2. Diet and Exercise Intervention Arm, 3. Bevacizumab, cyclophosphamide, methotrexate and diet intervention, 4. Bevacizumab, cyclophosphamide, methotrexate, diet and exercise intervention arm.
Primary Outcome
RFS events is defined as the duration of time from randomization to time of an RFS event, marked as positive if any of listed event shows: local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive), any other second cancer (excluding non-melanomatous skin cancer or cervical cancer in situ), or death from any cause. The diagnosis of local or distant recurrence should be pathologically confirmed however if biopsy if not possible, radiology confirmation acce
Interventions
- DRUG Cyclophosphamide
- DRUG Bevacizumab
- DRUG Methotrexate
- BEHAVIORAL Lifestyle: Diet
- BEHAVIORAL Lifestyle: Diet+Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2010-09 |
| Est. Completion | 2019-01-30 |
| Phase | Phase 2 |
Why NCT00925652 stopped before completion
NCT00925652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00925652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00925652 about?
NCT00925652 is a clinical study titled "Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer". If residual breast cancer is found in the breast or lymph node tissue removed after preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the future. The purpose of this research study is to determine if having additional treatment after preoperative chemotherapy and...
What is the current status of trial NCT00925652?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2010-09. Estimated completion is 2019-01-30.
What interventions are being tested in trial NCT00925652?
The interventions under investigation include: Cyclophosphamide (DRUG), Bevacizumab (DRUG), Methotrexate (DRUG), Lifestyle: Diet (BEHAVIORAL), Lifestyle: Diet+Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT00925652?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00925652's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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