Randomized Phase II Study of Neoadjuvant Chemotherapy and Trastuzumab (Herceptin) for Operable Breast Cancer with Overexpression of HER2

UMIN ID: UMIN000000651

Registered date:23/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2007/03/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

CPA/EPI/5-FU(500/100/500)/q3wks x 4 followed by paclitaxel(80)/qwk x 12/Trastuzumab/q3wks x 4
CPA/EPI/5-FU(500/100/500) x 4 followed by docetaxel (75)/q3wks x 4/Trastuzumab/q3wks x 4

Outcome(s)

• Primary Outcome: Pathological CR (pCR) rate Definition: no evidence of residual cancer in axillary lymph node and no evidence of residual invasive cancer in breast
• Secondary Outcome: Disease-Free Survival Adverse Events in neoadjuvant therapy PK study of Neoadjuvant Trastuzumab (10 patients of each arm) To evaluate predictive factors of pCR by cDNA array

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Female
• Exclude criteria: 1. Pregnant and nursing 2. Concomitant infectious disease 3. History of hypersensitivity to Cremophor EL(polyoxethylated castor oil) or polysorbate 4. Interstitual pneumonia or lung fibrosis 5. Hepatitis Virus B antigen positive 6. Diabetes Mellitus with uncontrolled status or insulin-therapy 7. Difficulty to participate because of mental disorder 8. Simultaneous double-cancer (exclude carcinoma in situ)

Related Information

• Primary Sponsor: Office for cordination of Herceptin trial
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): 18-3806