Multicenter phase II trial of weekly-paclitaxel and oral capecitabine combination therapy for metastatic breast cancer

UMIN ID: UMIN000000603

Registered date:09/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: metastatic breast cancer
• Date of first enrollment: 2007/02/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1) Paclitaxel 80mg/m2 (day 1,8 q3W) 2) Capecitabine 1650mg/m2 (day 1-14 followed by a week rest q3W)

Outcome(s)

• Primary Outcome: Progression Free Survival (PFS)
• Secondary Outcome: adverse event overall survival (OS) Time To Progression (TTF) Response rate, PFS and OS for breast cancer with ER/PgR/HER2 negative

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. severe complication 2. The brain metastasis which possesses condition 3. Past history of allergic reaction 4. Past history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 5. which has the use history of taxane or 5' DFUR or capecitabine (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen). 6. Peripheral neuropathy >= grade 2 in prior chemotherapy 7. Pregnant or lactating women 8. Doctor's decision for exclusion

Related Information

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