Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00365365 · ClinicalTrials.gov registry record · Phase 2
Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT00365365: Completed Phase 2 study, sponsored by Sanofi.
NCT00365365 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 214 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00365365, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study Summary
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.
Primary Outcome
Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance thera
Interventions
- DRUG Doxorubicin and cyclophosphamide (AC) + bevacizumab
- DRUG Docetaxel (T) + bevacizumab
- DRUG Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab
- DRUG Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab
- DRUG Bevacizumab and trastuzumab maintenance therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2006-08 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT00365365 record still lists
NCT00365365 is an interventional study that assigns participants to a tested intervention. The registered 214 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 (61% higher).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin and cyclophosphamide (AC) + bevacizumab is the first listed.
NCT00365365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00365365 about?
NCT00365365 is a clinical study titled "Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer". This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants wi...
What is the current status of trial NCT00365365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2006-08. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00365365?
The interventions under investigation include: Doxorubicin and cyclophosphamide (AC) + bevacizumab (DRUG), Docetaxel (T) + bevacizumab (DRUG), Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab (DRUG), Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab (DRUG), Bevacizumab and trastuzumab maintenance therapy (DRUG).
Who is sponsoring clinical trial NCT00365365?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00365365's enrollment target sits among peer trials
214 290th of 2000 higher than 1,711 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
- NCT04421248 · 214 participants · Phase 4
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
- NCT04667520 · 214 participants · NA
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
- NCT05418868 · 214 participants · Phase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia