Randomized study of docetaxel or weekly paclitaxel followed by 5FU + epirubicin + cyclophosphamide as preoperative chemotherapy for primary breast cancer

UMIN ID: UMIN000000916

Registered date:01/12/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: primary breast cancer
• Date of first enrollment: 2007/12/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

docetaxel 75mg/m2 every three weeks, four cycles
paclitaxel 80mg/m2 day1, 8, 15, every three weeks, four cycles

Outcome(s)

• Primary Outcome: pathological complete response rate
• Secondary Outcome: clinical response rate, safety, breast conserving rate, progression free survival, overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) severe comorbidity 2) alergy to polysorbate 80 3) alergy to clemohol EL 4) active infection 5) severe peripheral neuropathy 6) alcohol intolerance 7) pregnant or lactating women

Related Information

• Primary Sponsor: kobe breast cancer oncology group
• Source(s) of Monetary Support: none