Docetaxel in Node Positive Adjuvant Breast Cancer

NCT00688740 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC6041XRP6976D-316BCIRG001
• Study Type: interventional
• Target: 1,491
• Locations: 20 countries
• Sites: 20

Brief Summary

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.

Conditions

Breast Cancer

Keywords

adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Disease-Free Survival Events

  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.

  up to 10 year follow-up

Secondary Outcomes (2)

• Number of Participants With Overall Survival Events

  up to 10 year follow-up

• Number of Participants With Second Primary Malignancies (Toxicity)

  up to 10 year follow-up

Study Arms (2)

TAC (Docetaxel)

EXPERIMENTAL

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

Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide

FAC (5-fluorouracil)

ACTIVE COMPARATOR

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

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

Interventions

Docetaxel DRUG

intravenous

Also known as: Taxotere®

TAC (Docetaxel)

5-fluorouracil DRUG

intravenous

Also known as: 5-FU

FAC (5-fluorouracil)

Doxorubicin DRUG

intravenous

FAC (5-fluorouracil); TAC (Docetaxel)

Cyclophosphamide DRUG

intravenous

FAC (5-fluorouracil); TAC (Docetaxel)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
• Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

Sponsors & Collaborators

• Sanofi: lead
• Cancer International Research Group (CIRG): collaborator

Study Sites (20)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Location

Sanofi-Aventis Administrative Office

Vienna, Austria

Location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Sanofi-Aventis Administrative Office

Prague, Czechia

Location

Sanofi-Aventis Administrative Office

Cairo, Egypt

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

Sanofi-Aventis Administrative Office

Athens, Greece

Location

Sanofi-Aventis Administrative Office

Budapest, Hungary

Location

sanofi-aventis Administrative office

Netanya, Israel

Location

Sanofi-Aventis Administrative Office

Warsaw, Poland

Location

Sanofi-Aventis Administrative Office

Porto Salvo, Portugal

Location

Sanofi-Aventis Administrative Office

Bratislava, Slovakia

Location

Sanofi-Aventis Administrative Office

Midrand, South Africa

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

Sanofi-Aventis Administrative Office

Bromma, Sweden

Location

Sanofi-aventis adminsitrative office

Guildford Surrey, United Kingdom

Location

Sanofi-aventis administrative office

Montevideo, Uruguay

Location

Related Publications (2)

• Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.

  PMID: 15930421 RESULT

• Mackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodriguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houe V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12.

  PMID: 23246022 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Fluorouracil; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: International Clinical Development Study Director
• Organization: sanofi-aventis

Contact-us@sanofi-aventis.com

Study Officials

• ICD

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: June 1, 1997
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 16, 2011
• Results First Posted: February 14, 2011

Record last verified: 2011-02

Locations

ES (1); DE (1); UR (1); ZA (1); US (1); GR (1); BR (1); HU (1); AR (1); FR (1); PT (1); EG (1); SL (1); SE (1); GB (1); CA (1); CZ (1); IL (1); PL (1); AU (1)