Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expressio
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-C000000165
- Lead Sponsor
- Toukai Breast Cancer Clinical Reserch Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) efficacy 2) safety
- Secondary Outcome Measures
Name Time Method 1) histologic effect 2) overall survival