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NCT00861705 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 454
- Enrollment target
NCT00861705: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00861705 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 454 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (241% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00861705, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 454 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- BIOLOGICAL Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2009-07-21 |
| Est. Completion | 2025-09-02 |
| Phase | Phase 2 |
What the finished NCT00861705 record still lists
NCT00861705 is an interventional study that assigns participants to a tested intervention. The registered 454 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (241% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00861705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00861705 about?
NCT00861705 is a clinical study titled "Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery". This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubici...
What is the current status of trial NCT00861705?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 454 participants. The study started on 2009-07-21. Estimated completion is 2025-09-02.
What interventions are being tested in trial NCT00861705?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00861705?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00861705's enrollment target sits among peer trials
454 87th of 2000 higher than 1,914 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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