Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
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|ClinicalTrials.gov Identifier: NCT00121992|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : February 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Docetaxel Drug: 5-fluorouracil Drug: Doxorubicin Drug: Cyclophosphamide||Phase 3|
- To compare disease-free survival (DFS) after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes.
- To compare overall survival (OS) between the 2 above mentioned arms.
- To compare toxicity and quality of life between the 2 above mentioned arms.
- To evaluate pathologic markers for predicting efficacy (hormonal receptors and human epidermal growth factor receptor 2 (HER2) protein expression).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1059 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 1999|
|Actual Primary Completion Date :||December 2, 2010|
|Actual Study Completion Date :||March 6, 2013|
Active Comparator: Arm A: FAC
FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv
Other Name: Adrucil
Other Name: adriamycin
Other Name: cytoxan
Experimental: Arm B: TAC
TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv
Other Name: Taxotere
Other Name: adriamycin
Other Name: cytoxan
- Disease-free survival (DFS) [ Time Frame: 10 year ]DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.
- Overall survival (OS) [ Time Frame: 10 year ]OS will be determined from the date of randomization until the date of death for any reason.
- The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study treatment ]Safety was assessed by standard clinical and laboratory tests. AE grade were defined by the NCI CTCAE v 1.0.
- Health related quality of life (HRQoL) [ Time Frame: Up to 120 weeks ]HRQoL was self-administered to patients during the 14 days prior to randomisation baseline), at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study.The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the breast cancer-specific quality-of-life questionnaire module (QLQ-BR23) were used.
- Pathological and molecular markers to predict efficacy [ Time Frame: 10 year ]Hormone-receptor status and HER2 protein expression will be analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and will be processed centrally.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121992
|Spanish Breast Cancer Research Group|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Director:||Study Director||Hospital Universitario San Carlos|