Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000001076
- Lead Sponsor
- Kinki Multidisciplinary Breast Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 35
Not provided
Histologically 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method