Phase I/II study of Chemotherapy with Nab-paclitaxel, Carboplatin and Trastuzumab in HER2-positive Locally Advanced Breast Cancer
- Conditions
- ocally advanced breast cancer
- Registration Number
- JPRN-UMIN000007600
- Lead Sponsor
- Department of Surgical Oncology, Osaka City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 22
Not provided
1)With history of hypersensitivity reaction for important medications in this treatment 2)Inflammatory breast cancer(T4d) 3)Synchronous double cancer (carcinoma in situ) which is controllable by local treatment is excluded 4)With uncontrollable infectious disease, diarrhea, ileus, diabetes, or other serious complications 5)With active pleural effusion or ascites 6)With serious heart disease, or the patient who has past history of it 7)With severe peripheral nerve disorder 8)With GI ulcer or GI hemorrhage 9)Having a past history of severe mental disorder or the patient who is under treatment of it 10)Pregnancy, or suspected pregnancy 11)HBs antigen positive or the patient for whom deoxyribonucleic acid analog is needed 12)Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose and recommended dose in phase I study Respose rate in phase II study
- Secondary Outcome Measures
Name Time Method