Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression

UMIN ID: C000000165

Registered date:12/09/2005

Basic Information

• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2004/08/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Preoperative chemotherapy of docetaxel and trastuzumab

Outcome(s)

• Primary Outcome: 1) efficacy 2) safety
• Secondary Outcome: 1) histologic effect 2) overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1)Drug allergy 2)Distant metastasis 3)Bilateral breast cancer 4)male 5)Double cancer 6)Uncontrollable complication 7)Heart disease 8) LVEF<50% by echocardiogram 9)Cardiac performance class II, III and IV by New York Heart Association Functional Classification 10)Sever infection 11)Motor paralysis or neuropathy 12)Pleural or subpericardial effusion 13)Pregnancy 14)Edema with grade G2 or more 15)Interstitial pneumonia or pulmonary fibrosis 16)Hypersensitivity for polysorubate 17) Positive HBs antigen 18)Psychological disease 19)Others

Related Information

• Primary Sponsor: Toukai Breast Cancer Clinical Reserch Group
• Source(s) of Monetary Support: non