Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer
- Conditions
- ER negative and HER2 positive breast cancer
- Registration Number
- JPRN-UMIN000019616
- Lead Sponsor
- Osaka Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 18
Not provided
1. With history of hypersensitivity reaction for important drug in this study 2. With history of invasive breast cancer 3. Bilateral invasive breast cancer 4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus 5. Positive for HBs antigen or HCV antibody 6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension 7. With severe edema 8. With severe peripheral neuropathy 9. With severe psychiatric disorder 10. Pregnant or nursing women 11. The case that is judged to be unsuitable for this study by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic complete response rate (Up to 12 weeks after the protocol therapy)
- Secondary Outcome Measures
Name Time Method Disease free survival Objective response rate Pathologocal response rate Rate of breast conserving surgery Safety profile