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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
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : August 10, 2005
Sponsor:
Collaborator:
Sanofi
Information provided by:
Spanish Breast Cancer Research Group

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

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  (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

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 10 year Disease-free survival (DFS)

Secondary Outcome Measures :
  1. 10 year Overall survival (OS)
  2. Toxicity
  3. Quality of life
  4. Biological markers


Information from the National Library of Medicine

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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:
High risk node negative breast cancer
Disease-Free survival
Quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
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