Phase III Randomized Adjuvant Study of Chemotherapy in Node Positive Breast Cancer Patients -AC(Anthracycline-Cyclophosphamide) 4 cycles followed by Taxane 4 cycles (AC-Tac) versus Taxane 8 cycles and Paclitaxel versus Docetaxel-

UMIN ID: C000000055

Registered date:12/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: node positive breast cancer
• Date of first enrollment: 2001/10/01
• Target sample size: 1200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

ACP : Adriamycin 60mg/m2 or Epirubicin 75mg/m2 (30min. drip phleboclysis, day1) + Cyclophosphamide 600mg/m2 (60min. drip phleboclysis, day1) 4 cycles followed by Paclitaxel 175g/m2 (3 hours drip phleboclysis, day1) 4 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
ACD : Adriamycin 60mg/m2 or Epirubicin 75mg/m2 (30min. drip phleboclysis, day1) + Cyclophosphamide 600mg/m2 (60min. drip phleboclysis, day1) 4 cycles followed by Dosetaxel 75g/m2 (1 hour drip phleboclysis, day1) 4 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
PTX : Paclitaxel 175g/m2 (3 hours drip phleboclysis, day1) 8 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)
DTX : Dosetaxel 75g/m2 (1 hour drip phleboclysis, day1) 8 cycles (1 cycle = 3 weeks, dosage on day1 of every cycle)

Outcome(s)

• Primary Outcome: Disease-Free Survival
• Secondary Outcome: Relapse-Free Survival Overall Survival Health-related QOL Adverse Events Efficacy of medical economy

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: (1)During pregnancy or lactation (2)Double invasive carcinoma(less than 5 years after the last treatment) (3)Metachronous bilateral breast cancer (4)Anaphylaxis against medicine using cremophor EL(polyoxethylated castor oil) or polysorbate as a solvent (5)Patients judged inappropriate for this study by the physicians

Related Information

• Primary Sponsor: N-SAS BC 02 executive committee
• Source(s) of Monetary Support: Public Health Research Foundation