Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study

UMIN ID: C000000265

Registered date:16/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2004/10/01
• Target sample size: 42
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): chemotherapy:FEC(fluoraouracil, epirubicin and cyclophosphamide)followed by P+H(weekly Paclitaxel+Trastuzumab)

Outcome(s)

• Primary Outcome: pathological complete rseponse rate
• Secondary Outcome: clinical response, treatment compliance, breast-conserving rate, safety, overall survical, disease-free survival

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: severe complication suspicious of infection Hypersensitivity for polyoxyethylene castor oil (Cremophor EL) containing drugs grade 3 or 4 peripheral neuropathy Male breast cancer Pregnant or lactating women Doctor' s decision for exclusion

Related Information

• Primary Sponsor: Breast Cancer PST Study Group
• Source(s) of Monetary Support: Breast Cancer PST Study Group