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NCT00312208 · ClinicalTrials.gov registry record · Phase 3
Docetaxel in Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,299
- Enrollment target
- 20
- Study locations
NCT00312208: Completed Phase 3 study of Breast Cancer, sponsored by Sanofi.
NCT00312208 is a Phase 3 study of Breast Cancer that has completed, run by Sanofi. The registered enrollment target is 3,299 participants, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00312208, a Phase 3 study of Breast Cancer, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,299 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary objective : * To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Secondary objectives : * To compare toxicity and quality of life between the 2 above-mentioned arms. * To evaluate pathologic and molecular markers for predicting efficacy.
Primary Outcome
The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Conditions Studied
Interventions
- DRUG docetaxel, doxorubicin, cyclophosphamide
- DRUG Docetaxel,doxorubicin, cyclophosphamide
Study Locations (20)
Other
- Sanofi-Aventis - Buenos Aires
- Sanofi-Aventis - Macquarie Park
- Sanofi-Aventis - Brussels
- Sanofi-Aventis - Sarajevo
- Sanofi-Aventis - São Paulo
- Sanofi-Aventis - Sofia
- Sanofi-Aventis - Laval
- Sanofi-Aventis - Shanghai
- Sanofi-Aventis - Bogotá
- Sanofi-Aventis - Zagreb
- Sanofi-Aventis - Nicosia
- Sanofi-Aventis - Prague
- Sanofi-Aventis - Cairo
- Sanofi-Aventis - Tallinn
- Sanofi-Aventis - Paris
- Sanofi-Aventis - Berlin
- Sanofi-Aventis - Kallithea
- Sanofi-Aventis - Hong Kong
- Sanofi-Aventis - Budapest
New Jersey
- Sanofi-Aventis - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,299 participants |
| Start Date | 2001-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT00312208 record still lists
NCT00312208 is an interventional study that assigns participants to a tested intervention. Its 3,299 participants enrollment target places it among the larger protocols in the corpus, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which docetaxel, doxorubicin, cyclophosphamide is the first listed.
NCT00312208 names 20 study sites across 2 states, led by Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00312208 about?
NCT00312208 is a clinical study titled "Docetaxel in Breast Cancer". Primary objective : * To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Seco...
What is the current status of trial NCT00312208?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,299 participants. The study started on 2001-11. Estimated completion is 2013-10.
What conditions does trial NCT00312208 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00312208?
The interventions under investigation include: docetaxel, doxorubicin, cyclophosphamide (DRUG), Docetaxel,doxorubicin, cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT00312208?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00312208 being conducted?
This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00312208's enrollment target sits among peer trials
3,299 45th of 1224 higher than 1,180 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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