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Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment

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ClinicalTrials.gov Identifier: NCT00121992
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
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 Drug: 5-fluorouracil Drug: Doxorubicin Drug: Cyclophosphamide 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 human epidermal growth factor receptor 2 (HER2) protein expression).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1059 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Actual Study Start Date : July 1999
Actual Primary Completion Date : December 2, 2010
Actual Study Completion Date : March 6, 2013


Arm Intervention/treatment
Active Comparator: Arm A: FAC
FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv
Drug: 5-fluorouracil
Other Name: Adrucil

Drug: Doxorubicin
Other Name: adriamycin

Drug: Cyclophosphamide
Other Name: cytoxan

Experimental: Arm B: TAC
TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv
Drug: Docetaxel
Other Name: Taxotere

Drug: Doxorubicin
Other Name: adriamycin

Drug: Cyclophosphamide
Other Name: cytoxan




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 10 year ]
    DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 10 year ]
    OS will be determined from the date of randomization until the date of death for any reason.

  2. The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study treatment ]
    Safety was assessed by standard clinical and laboratory tests. AE grade were defined by the NCI CTCAE v 1.0.

  3. Health related quality of life (HRQoL) [ Time Frame: Up to 120 weeks ]
    HRQoL was self-administered to patients during the 14 days prior to randomisation baseline), at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study.The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the breast cancer-specific quality-of-life questionnaire module (QLQ-BR23) were used.

  4. Pathological and molecular markers to predict efficacy [ Time Frame: 10 year ]
    Hormone-receptor status and HER2 protein expression will be analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and will be processed centrally.



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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
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Spain
Spanish Breast Cancer Research Group
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Sanofi
Investigators
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Study Director: Study Director Hospital Universitario San Carlos

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00121992    
Other Study ID Numbers: GEICAM 9805
TAX.ES1.301 ( Other Identifier: RHÔNE-POULENC RORER, S.A. (RPR) )
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Keywords provided by Spanish Breast Cancer Research Group:
High risk node negative breast cancer
Disease-Free survival
Quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin
Fluorouracil
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