NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000055

Registered date:12/08/2005

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-

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiednode positive breast cancer
Date of first enrollment2001/10/01
Target sample size1200
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeDisease-Free Survival
Secondary OutcomeRelapse-Free Survival Overall Survival Health-related QOL Adverse Events Efficacy of medical economy

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximum70years-old
GenderFemale
Include criteria
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

Contact

public contact
Name Akira Yamao
Address 1-1-7, Nishiwaseda, shinjyuku-ku Tokyo, 169-0051 JAPAN Japan
Telephone 03-5287-2633
E-mail support@csp.or.jp
Affiliation Public Health Research Foundation Comprehensive Support Project for Clinical Research
scientific contact
Name Toru Watanabe
Address Hamamatsu Oncology Center Building 1F,3-6-13 ,Chuo,Naka-ku, Hamamatsu-shi,Shizuoka,430-0929,Japan Japan
Telephone 053-452-6940
E-mail no@mail
Affiliation Hamamatsu Oncology Center Department of Oncology