Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer

UMIN ID: C000000397

Registered date:06/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2005/12/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 4 cycles of FEC (Fluorouracil 500 mg/m2 / Epirubicin 75 mg/m2 / Cyclophosphamide 500mg/m2), every 3 weeks, then 4 cycles•of Docetaxel 70 mg/m2 every 3 weeks.

Outcome(s)

• Primary Outcome: Disease-free survival
• Secondary Outcome: Safety, feasibility

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: 1) Bilateral breast cancer 2)A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 3)Inflammatory breast cancer 4)Male 5)A history of hypersensitivity reaction to any drugs. 6)Uncontrolled medical conditions. 7)Suspected of infection with fever 8)Severe peripheral neuropathy (>Grade 1). 9)Symptomatic varicella. 10)Treatment required pleural or pericardial effusions 11)Severe peripheral edema. 12)Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13)Patients who are required concurrent treatment by corticosteroids. 14)Severe psychiatric disorders 15)Pregnant or lactation women, or women with suspected pregnancy 16)Patients judged by the investigator to be unfit to be enrolled into the study

Related Information

• Primary Sponsor: Kyushu Breast Cancer Study Group
• Source(s) of Monetary Support: non profit organization Clinical hematology oncology study group