ab-Paclitaxel plus trastuzumab and pertuzumab as a neoadjuvant chemotherapy for low-risk HER2-positive breast cancer
Phase 2
Recruiting
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000051060
- Lead Sponsor
- Gifu University Graduate School of Medicine Breast Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1)Inflammatory and/or bilateral breast cancer 2)Duplicated/sunchromus/metachromus cancer(DFS less than 5y) 3)Severe complication (cardiovascular, lung, liver disease, homorragic ulcer etc.) 4)febrile, susupicious for infection 5)Interstitial pneumonia or pulmonary fibrosis by chest-X/CT 6)Active systhemic infevtion (HBV, HCV, HIV etc.) 7)Uncontrollable pheripheral pneuropathy due to DM, V-12 deficiency etc. 8)Severe allergy to drug 9)Pregnancy, Lactation 10)Uncontrollable mental disease 11)Not suitable for this study judged by physician/Surgeon
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pCR rate
- Secondary Outcome Measures
Name Time Method Response rate Pathological evaluaion Breast conserving rate Safety (change of LVEF, CIPN etc) Evaluation after 6 cycles of nabPTX/TZ/PER RDI DFS Evaluation of TILs/SPARC in biopsy samples immune-related factor Adjuvant therapy