Breast Cancer
Conditions
Interventions
Nab-paclitaxel(260mg/m2) Trastuzumab( 1st: 8mg/kg, 2nd: 6mg/kg) Pertuzumab (1st 840mg, 2nd 420mg) 6kurr (3qw)
Sponsors
Gifu University Graduate School of Medicine Breast Surgery
Gihoku kosei hospital Gifu municipal hospital Gifu prefectual general medical center Ibi kosei hospital Municipal Ena hospital Daiyukai general hospital Asahi Univ. hospital Takayama red rross hospital Chubu International Medical Center Matsunami General Hospital Tajimi municipal hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with breast cancer 2) HER2-type 3)Tumour diameter<3 cm, negative for lymph node metastases 4)Curable by neoadjuvant chemotherapy and surgery 5) cases with measurable lesion 6) age 20-74 at registration 7) PS(ECOG) 0-1 8) No therapy before registration 9) LVEF >50% by UCG 10) WBC >3,000/mm3 Neutrophil >1,500/mm3 Platelet >100,000/mm3 Hb >9.0 g/dL AST(GOT) <ULN x3 ALT(GPT) <ULN x3 T-Bil <2 mg/dL Cr <2 mg/dL 11) Informed consent obtained from IC
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactManabu Futamura
Gifu University Graduate School of Medinine Breast Surgery
Outcome results
None listed