NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001076

Registered date:13/03/2008

Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast Cancer
Date of first enrollment2006/07/01
Target sample size35
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Docetaxel 75 mg/m2, IV, Day 1 Cyclophosphamide 600mg/m2, IV, Day 1 Every 21 days for 6 cycles

Outcome(s)

Primary OutcomePlanned treatment completion rate
Secondary OutcomeToxicity, Mean delivered treatment course, Relative dose-intensity

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum70years-old
GenderFemale
Include criteria
Exclude criteriaHistologically proven female breast cancer who underwent complete surgical excision No incidence of axillary metastasis by lymph node dissection or sentinel node biopsy Age >= 20 to =<34 or >=35 to =<70 who fills one of the followings (St.Gallen category of node-negative with intermediate risk) Tumor size >2cm Histologic and / or nuclear grade2-3 Presence of peritumoral vascular invasion HER2 IHC (3+) or FISH (+) ER (-) ECOG PS 0-1 No more than 2 weeks from the lastsurgery Patients were required to have leukocyte >= 4000/mm3 or neutrophil >= 2000/mm3 hemoglobin >= 10 g/dL platelet count >= 100,000/ mm3 total bilirubin =< 1.5 mg/dL AST =< 2.5x the upper limit of normal serum creatinine less than 1.5 mg/dL Sufficient organ function Written informed consent

Related Information

Contact

public contact
Name Norikazu Masuda
Address Osaka National Hospital, Department of Surgery Japan
Telephone 06-6942-1331
E-mail
Affiliation Kinki Multidisciplinary Breast Oncology Group Secretariat office
scientific contact
Name Norikazu Masuda
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, JAPAN 540-0006 Japan
Telephone 06-6942-1331
E-mail
Affiliation Osaka Medical Center Surgery