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(1)Histologically proven primary breast cancer (2)StageI,IIA,IIIB,IIIA (TNM staging system) (3)Proven node positive by node dissection or sentinel node biopsy (4)PS (Eastern Cooperative Oncology Group performance status scale) 0,1 (5)Relations to other treatments are (a)Treatment of this study started within 12 weeks after mastectomy/breast-conserving surgery or node dissection, (b)No postoperative radiation, and (c)No endocrinotherapy, chemotherapy (6)WBC>=4,000 or neutrophilic leukocyte>=2,000, PLT>=100,000,T-B=<1.5 , GPT(ALT)=<(every institution's reference value)*2.5, CRE<=1.5 (these values are tested within 2 weeks before registration for this study), no cardiac infraction or congestive heart failure, no grave ischemic heart disease or valvular disease (7)Written informed consent
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