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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


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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).


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

10 year Disease-free survival (DFS)

Principal Investigator

Miguel Martín, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Breast Cancer Research Group

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM 9805

NCT ID:

NCT00121992

Start Date:

June 1999

Completion Date:

June 2005

Related Keywords:

  • Breast Neoplasms
  • High risk node negative breast cancer
  • Disease-Free survival
  • Quality of life
  • Breast Neoplasms
  • Neoplasms

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