Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-Fluorouracil in Combination With Doxorubicin and Cyclophosphamide (5 FAC) as Adjuvant Treatment of Breast Cancer Patients
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Breast Neoplasms |
| Intervention | Drug: Docetaxel/Doxorubicin/cyclophosphamide (75/50/500) mg/m2 q3w |
| Phase | Phase 3 |
| Sponsor | Spanish Breast Cancer Research Group |
| Responsible Party | Spanish Breast Cancer Research Group |
| ClinicalTrials.gov Identifier | NCT00121992 |
| First Received | July 18, 2005 |
| Last Updated | August 8, 2005 |
| Last verified | August 2005 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 18, 2005 |
|---|---|
| Last Updated Date | August 8, 2005 |
| Start Date | June 1999 |
| Estimated Primary Completion Date | June 2005 |
| Current Primary Outcome Measures | 10 year Disease-free survival (DFS) |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-Fluorouracil in Combination With Doxorubicin and Cyclophosphamide (5 FAC) as Adjuvant Treatment of Breast Cancer Patients |
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| Official Title | A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-Fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes |
| 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. |
| Detailed Description | Primary objective: - 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. Secondary objectives: - 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 c-erB-2). |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Neoplasms |
| Intervention | Drug: Docetaxel/Doxorubicin/cyclophosphamide (75/50/500) mg/m2 q3w |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1054 |
| Estimated Completion Date | June 2005 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Written informed consent - Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria. - Histologically proven breast cancer. Interval between surgery and registration is less than 60 days. - Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin. - Patients without proven metastatic disease. - Estrogen and progesterone receptors performed on the primary tumour prior to randomization. - Age between 18 years and 70 years. - Karnofsky performance status index > 80 %. - Adequate hepatic, renal and heart functions. - Adequate hematology levels. - Negative pregnancy test Exclusion Criteria: - Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy). - Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy. - Prior radiation therapy for breast cancer. - Bilateral invasive breast cancer. - Pregnant, or lactating patients. - Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment . - Any T4 or N1-3 or M1 breast cancer. - Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria. - Other serious illness or medical condition - Past or current history of neoplasm other than breast carcinoma. - Ipsilateral ductal carcinoma in-situ (DCIS) of the breast. - Lobular carcinoma in-situ (LCIS) of the breast. - Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose - Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry. - Definite contraindications for the use of corticosteroids. - Concurrent treatment with other experimental drugs. - Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. - Concurrent treatment with any other anti-cancer therapy. - Male patients. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Spain |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00121992 |
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| Other Study ID Numbers | GEICAM 9805 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Spanish Breast Cancer Research Group |
| Study Sponsor | Spanish Breast Cancer Research Group |
| Collaborators | Sanofi |
| Investigators | Study Chair: Miguel Martín, MD, PhD Spanish Breast Cancer Research Group |
| Verification Date | August 2005 |
Locations[ + expand ][ + ]
| Spanish Breast Cancer Research Group | San Sebastián de los Reyes, Madrid, Spain, 28700 |
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