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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 3,222 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00021255
The ClinicalTrials.gov registry entry for NCT00021255 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00021255 reports 0 study locations.
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.
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