Trial record 1 of 1 for:
9805 Breast
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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| ClinicalTrials.gov Identifier: NCT00121992 |
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Recruitment Status :
Completed
First Posted : July 21, 2005
Last Update Posted : August 10, 2005
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Sponsor:
Spanish Breast Cancer Research Group
Collaborator:
Sanofi
Information provided by:
Spanish Breast Cancer Research Group
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Neoplasms | Drug: Docetaxel/Doxorubicin/cyclophosphamide (75/50/500) mg/m2 q3w | Phase 3 |
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 (Clinical Trial) |
| Enrollment : | 1054 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | June 1999 |
| Study Completion Date : | June 2005 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Primary Outcome Measures :
- 10 year Disease-free survival (DFS)
Secondary Outcome Measures :
- 10 year Overall survival (OS)
- Toxicity
- Quality of life
- Biological markers
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes 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.
Information from the National Library of Medicine
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
Locations
| Spain | |
| Spanish Breast Cancer Research Group | |
| San Sebastián de los Reyes, Madrid, Spain, 28700 | |
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Sanofi
Investigators
| Study Chair: | Miguel Martín, MD, PhD | Spanish Breast Cancer Research Group |
Additional Information:
Publications:
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 |
| First Posted: | July 21, 2005 Key Record Dates |
| Last Update Posted: | August 10, 2005 |
| Last Verified: | August 2005 |
Keywords provided by Spanish Breast Cancer Research Group:
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High risk node negative breast cancer Disease-Free survival Quality of life |
Additional relevant MeSH terms:
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Breast Neoplasms Breast Diseases Neoplasms by Site Neoplasms Skin Diseases Cyclophosphamide Fluorouracil Docetaxel Liposomal doxorubicin Doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antimetabolites Antimetabolites, Antineoplastic |