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:
Collaborator:
Sanofi
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
  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:


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
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).
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Liposomal doxorubicin
Cyclophosphamide
Doxorubicin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on September 18, 2014