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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 Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

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 Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.


In addition to the 5-year analysis conducted in September 2003, two other analyses were
planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower
than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final
analysis at 10 years was considered more appropriate than an event-based (700 Disease Free
Survival events) analysis.


Inclusion Criteria:



- Histologically proven breast cancer (invasive adenocarcinoma with at least one
axillary lymph node showing evidence of tumor among a minimum of six resected lymph
nodes).

- Definitive surgical treatment must be either mastectomy, or breast conserving surgery
with axillary lymph node dissection for operable breast cancer. Margins of resected
specimen from definitive surgery must be histologically free of invasive
adenocarcinoma and ductal carcinoma.

Exclusion criteria:

- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy,
chemotherapy).

- Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Disease-Free Survival Events

Outcome Description:

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

Outcome Time Frame:

up to 10 year follow-up

Safety Issue:

No

Principal Investigator

ICD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Poland: Ministry of Health

Study ID:

EFC6041

NCT ID:

NCT00688740

Start Date:

June 1997

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • adjuvant treatment
  • Breast Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807