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
This study has been completed.
Sponsor:
Spanish Breast Cancer Research Group
Collaborator:
Sanofi-Aventis
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00121992
First received: July 18, 2005
Last updated: August 8, 2005
Last verified: August 2005
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Docetaxel/Doxorubicin/cyclophosphamide (75/50/500) mg/m2 q3w |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Fluorouracil
Doxorubicin
Doxorubicin hydrochloride
Docetaxel
U.S. FDA Resources
Further study details as provided by Spanish Breast Cancer Research Group:
Primary Outcome Measures:
- 10 year Disease-free survival (DFS)
Secondary Outcome Measures:
- 10 year Overall survival (OS)
- Toxicity
- Quality of life
- Biological markers
| Estimated Enrollment: | 1054 |
| Study Start Date: | June 1999 |
| Estimated Study Completion Date: | June 2005 |
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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121992
Locations
| Spain | |
| Spanish Breast Cancer Research Group | |
| San Sebastián de los Reyes, Madrid, Spain, 28700 | |
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Sanofi-Aventis
Investigators
| Study Chair: | Miguel Martín, MD, PhD | Spanish Breast Cancer Research Group |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00121992 History of Changes |
| Other Study ID Numbers: | GEICAM 9805, TAX.ES1.301 |
| Study First Received: | July 18, 2005 |
| Last Updated: | August 8, 2005 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Spanish Breast Cancer Research Group:
|
High risk node negative breast cancer Disease-Free survival Quality of life |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Docetaxel Doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on October 16, 2012
