Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers

UMIN ID: UMIN000002215

Registered date:17/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2009/02/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

FEC-DOC Group: 5-FU 500mg/m2 iv day1 Epirubicin 100mg/ m2/day 1 Cyclophosphamide 500mg/m2 iv day1 Every 21 days for 3 cycles, then Docetaxel 100 mg/m2 iv day1 Every 21 days for 3 cycles After completing treatment, surgical operation is performed.
Cyclophosphamide 600mg/m2 iv day1 Docetaxel 75mg/m2 iv day1 Every 21 days for 6 cycles. After completing treatment, surgical operation is performed.

Outcome(s)

• Primary Outcome: histological effect
• Secondary Outcome: Safety Breast conservation rate Recurrence-free survival Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Female
• Exclude criteria: 1)A history of hypersensitivity reaction to any drugs. 2)seriously compromised 3)Suspected of infection with fever 4)peripheral neuropathy 5)Treatment required pleural or pericardial effusions 6)complication of the active other malignancies 7)Inflammatory breast cancer 8)Male 9)Pregnant or lactation women, or women with suspected pregnancy 10)edema 11)Symptomatic varicella 12) Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13) Patients who are required concurrent treatment by corticosteroids except for premedication 14)psychological disorders 15) Patients judged by the investigator to be unfit to be enrolled into the study

Related Information

• Primary Sponsor: Yokohama City University medical center Breast and thyroid surgery
• Source(s) of Monetary Support: None