Phase II Study of Primary Chemotherapy with Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients with HER2 Positive Breast Cancer
- Conditions
- Patients with HER2 positive operable breast cancer
- Registration Number
- JPRN-UMIN000006288
- Lead Sponsor
- Breast and endocrine surgery Osaka Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 45
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 and with history of HVB 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. Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the pathologic complete response rate
- Secondary Outcome Measures
Name Time Method To evaluate the disease free survival To evaluate the overall response rate To evaluate the histological therapeutic effect To assess breast conserving rate after preoperative chemotherapy To assess the adverse events