Skip to main content
OpenTrials
Completed

NCT Number: NCT00688740

Docetaxel in Node Positive Adjuvant Breast Cancer

The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms 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

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

docetaxel

Drug

intravenous

Other names: Taxotere®

5-fluorouracil

Drug

intravenous

Other names: 5-FU

Doxorubicin

Drug

intravenous

Cyclophosphamide

Drug

intravenous

Primary outcomes

  1. Number of Participants With Disease-Free Survival Events

    Time frame: up to 10 year follow-up

    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.

Secondary outcomes

  1. Number of Participants With Overall Survival Events

    Time frame: up to 10 year follow-up

    Overall Survival - time from the date of randomization up to the date of death of any cause.

  2. Number of Participants With Second Primary Malignancies (Toxicity)

    Time frame: up to 10 year follow-up

    Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Cancer International Research Group (CIRG)

Registry information

Official study 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 Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.

Acronym: TAX316

Important dates

Study start
1997
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2008
Registry last updated
Feb 16, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.