Clinical Trial: NCT00121992
Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Spanish Breast Cancer Research Group |
| Information Provided By: | Spanish Breast Cancer Research Group |
| Last Update Posted: | 2023-04-04 |
Study Overview
Brief Summary
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:
- TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
- FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
Official Title
Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Conditions
Breast Neoplasms
Intervention / Treatment
- Drug: Docetaxel
- Drug: 5-fluorouracil
- Drug: Doxorubicin
- Drug: Cyclophosphamide
Other Study ID Numbers
- GEICAM 9805
- TAX.ES1.301
Start Date (Actual)
1999-07
Primary Completion Date (Actual)
2010-12-02
Study Completion Date (Actual)
2013-03-06
Enrollment (Actual)
1060
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Spanish Breast Cancer Research Group |
| Information Provided By: | Spanish Breast Cancer Research Group |
| Last Update Posted: | 2023-04-04 |
Study Overview
Brief Summary
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:
- TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
- FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
Official Title
Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Conditions
Breast Neoplasms
Intervention / Treatment
- Drug: Docetaxel
- Drug: 5-fluorouracil
- Drug: Doxorubicin
- Drug: Cyclophosphamide
Other Study ID Numbers
- GEICAM 9805
- TAX.ES1.301
Start Date (Actual)
1999-07
Primary Completion Date (Actual)
2010-12-02
Study Completion Date (Actual)
2013-03-06
Enrollment (Actual)
1060
Study Type
Interventional
Phase
Phase 3