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NCT00021255 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,222
- Enrollment target
NCT00021255: Completed Phase 3 study, sponsored by Sanofi.
NCT00021255 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 3,222 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (317% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00021255, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,222 participants
- Enrollment target
Study Summary
Primary objective: * Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin. Secondary objective: * Compare overall survival of participants treated with these regimens. * Compare the toxic effects (including cardiac) of these regimens in these participants. * Compare quality of life of participants treated with these regimens. * Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants. * For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.
Primary Outcome
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Doxorubicin
- DRUG Herceptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,222 participants |
| Start Date | 2001-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT00021255 record still lists
NCT00021255 is an interventional study that assigns participants to a tested intervention. Its 3,222 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (317% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00021255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00021255 about?
NCT00021255 is a clinical study titled "Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer". Primary objective: * Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) ...
What is the current status of trial NCT00021255?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,222 participants. The study started on 2001-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00021255?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), Herceptin (DRUG).
Who is sponsoring clinical trial NCT00021255?
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 NCT00021255's enrollment target sits among peer trials
3,222 73rd of 2000 higher than 1,928 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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