BIG 02/98 Docetaxel - Breast Cancer

Summary

Primary objectives:

* To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes.

Secondary objectives:

* To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes
* To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes
* To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy).
* To compare overall survival of treatment arms.
* To compare toxicity of treatment arms.
* To evaluate pathologic and molecular markers for predicting efficacy.
* Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.

Conditions

• Breast Neoplasms

Interventions

DRUG

Doxorubicine + docetaxel sequential

doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles

DRUG

doxorubicine + cyclophosphamide sequential

doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles

DRUG

doxorubicine + cyclophosphamide combined

doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.

DRUG

doxorubicine + docetaxel combined

doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Principal Investigators

• Jean-Philippe Aussel · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-06-30

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• Australia
• Austria
• Belgium
• Brazil
• Chile
• Czechia
• Denmark
• Germany
• Hungary
• Ireland
• Israel
• Italy
• New Zealand
• Portugal
• Slovakia
• Slovenia
• South Africa
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations