Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: 5-fluorouracil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00688740

XRP6976D-316

BCIRG001

EFC6041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,491 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,491 participants in 2 patient groups

TAC (Docetaxel)

Experimental group

Description:

docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment

Treatment:

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Docetaxel

FAC (5-fluorouracil)

Active Comparator group

Description:

5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment

Treatment:

Drug: Cyclophosphamide

Drug: 5-fluorouracil

Drug: Doxorubicin