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

UMIN ID: UMIN000001076

Registered date:13/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2006/07/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel 75 mg/m2, IV, Day 1 Cyclophosphamide 600mg/m2, IV, Day 1 Every 21 days for 6 cycles

Outcome(s)

• Primary Outcome: Planned treatment completion rate
• Secondary Outcome: Toxicity, Mean delivered treatment course, Relative dose-intensity

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: Kinki Multidisciplinary Breast Oncology Group
• Source(s) of Monetary Support: Sakai Clinical Research Supporting Center(SCRSC)