A phase II neoadjuvant trial of concurrent trastuzumab, paclitaxel and endocrine therapy in women with HER2-positive and hormone receptor-positive breast cancer.

UMIN ID: UMIN000009108

Registered date:17/10/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: women with HER2-positive and hormone receptor-positive breast cancer
• Date of first enrollment: 2012/10/17
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Eligible premenopausal women receive tamoxifen 20mg/d orally and trastuzumab is given with a loading dose of 4 mg/kg; subsequent doses are 2 mg/kg every week. In addition, paclitaxel is given at a dose of 80 mg/m2; every week for 12 weeks. Eligible postmenopausal women receive letrozole 2.5mg/d orally and trastuzumab is given with a loading dose of 4 mg/kg; subsequent doses are 2 mg/kg every week. In addition, paclitaxel is given at a dose of 80 mg/m2; every week for 12 weeks.

Outcome(s)

• Primary Outcome: clinical response rate, tumor reduction rate
• Secondary Outcome: pathological CR rate, adverse event, breast conserving rate, relapse free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1. Other active malignancies 2. Hemorrhagic diathesis 3. History of cardiac infarction, valvular diseases of the heart and severe cardiac disfunction 4. Liver cirrhosis 5. Other medical conditions that could limit a patient's ability to undertake study therapy

Related Information

• Primary Sponsor: Keio University School of Medicine
• Source(s) of Monetary Support: Keio University School of Medicine