Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)

UMIN ID: UMIN000001205

Registered date:21/06/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Primary breast cancer
• Date of first enrollment: 2008/06/01
• Target sample size: 63
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 12 cycles of wPTX followed by 4 cycles of ADM+PTX (AP) PTX 80mg/m2 12 cycles 1) day1; PTX 80mg/m2 after completion wPTX, day22 would be day1 and followed by AP 4 cycles (q3weeks) 1) day1; ADM 50mg/m2 2) day1; PTX 150mg/m2

Outcome(s)

• Primary Outcome: Pathological complete response; pCR rate
• Secondary Outcome: Clinical response rate Disease free survival Overall survival Breast conserving rate Treatment compliance Biomarkers

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1)Severe complication 2)Inflammatory breast caner and male breast cancer 3)Ischemic heart disease or arrhythmia which needs medical treatment (history of myocardial infarction occured within 6 months) 4)Uncontrolled diabetes 5)Suspicious of infection 6)History of serious hypersensitivity or history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 7)During pregnancy or lactation 8)Patient judged inappropriate by physicians

Related Information

• Primary Sponsor: Saitama Breast Cancer Clinical Study Group (SBCCSG)
• Source(s) of Monetary Support: none