Latest Communications

• BCIRG 001 Molecular Analysis presented at ASCO 2007.
  
• Publication of the 001 study results in the New England Journal of Medecine Volume 352:2302-2313, June 2 2005.
  The article's title is: "Adjuvant Docetaxel for Node-Positive Breast Cancer". Click below to access to the article and to the CIRG press release:
  >>> http://content.nejm.org/cgi/content/short/352/22/2302
  
  >>> CIRG Press Release
  
• FDA approval on August, 19 2004 following BCIRG 001 study on Docetaxel (Taxotere) based regimen, TAC for treatment of women with node-positive early-stage breast cancer, click here for more information. 
  
• From ASCO, June 5 2004: Poster session

Abstract:Dr. Charles Vogel (n°677)

Poster: "The role of growth factor support following neutropenic events in early stage breast cancer (BC)"

·         From EBCC-4, March 17, 2004.

Abstract: Dr Miguel Martin abstract (n°50)."Docetaxel-based regimen (TAC) improves DFS and OS over FAC in node positive early breast cancer patients: Efficacy, safety and quality of life at 55 month followup"

·         From San Antonio (SABCS), December 2003: Results of the second planned analysis after 55 months of follow-up

Abstract:BCIRG 001-SABCS2003 Abstract

Slides: Dr Mackey's oral presentation

International Press Release:BCIRG 001 Press Release December 3rd 2003 

·         From ASCO, May 2002: Results of the first planned analysis

Abstract: 141 ASCO abstract final

Slides: BCIRG 001 ASCO

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

Study Chairs

Miguel Martin, MD; John Mackey, MD;Chuck Vogel, MD

Sponsor

Aventis Oncology

Rationale

TAC has been shown to be more active than standard FAC in the metastatic setting (Nabholtz et al, ASCO 2001). This study is designed to determine if that higher activity will translate into prolonged disease free and overall survival in the adjuvant setting.

 Design 

TAC (75/50/500 mg/m2) q21day x 6 cycles

FAC (500/50/500 mg/m2) q21day x 6 cycles

Major eligibility criteria

• Histologically proven breast cancer
• Definitive surgical treatment is mastectomy or BCT (must include axillary LN dissection)
• At least 1 positive node out of a minimum of 6 dissected
• Stage T 1-3, N1, M0
• Age < 70 years, KPS > 80%
• Normal bone marrow, liver, renal and cardiac function
• No prior systemic therapy or RT for breast cancer
• Informed consent

Endpoints

Primary: Disease free survival
Secondary: Overall survival, toxicity and quality of life, and to evaluate pathologic and molecular markers for predicting efficacy

Number of Patients

1,491 patients

Status

Enrollment complete, second interim results reported. Results published in NEJM Volume 352:2302-2313, June 2 2205.