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Completed

NCT Number: NCT00121992

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Spanish Breast Cancer Research Group

San Sebastián de los Reyes, Madrid, 28700, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

Other names: Taxotere

5-fluorouracil

Drug

Other names: Adrucil

Doxorubicin

Drug

Other names: adriamycin

Cyclophosphamide

Drug

Other names: cytoxan

Primary outcomes

  1. Disease-free Survival (DFS) Events

    Time frame: 10 years

    DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 10 years

    OS was determined from the date of randomization until the date of death for any reason.

    OS is calculated from the date of randomization up to the first date of death by any cause.

  2. The Number of Participants Who Experienced Adverse Events (AE)

    Time frame: Through study treatment, and average of 4 months

    Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 1.0.

  3. Best Score During Study for Global Health Status Scale

    Time frame: 120 weeks

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used.

    Questionnaires were 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 Global Health Status Scale has been used, which is calculated with questions 29 and 30 from the EORTC QLQ-C30. From this scale, the best score is the highest score observed during study (of all the questionnaires completed by patient). In this scale, scores range from 0 to 100 and a high score represents a high level of functioning or HRQoL.

  4. Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup

    Time frame: 10 year

    Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.

  5. Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup

    Time frame: 10 year

    Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally.

    Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.

  6. Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup

    Time frame: 10 year

    Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally.

  7. Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup

    Time frame: 10 year

    Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.

Sponsors and collaborators

Lead sponsor

Spanish Breast Cancer Research Group

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2010
Study completion
2013
First posted
Jul 21, 2005
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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