Breast Cancer
Conditions
Interventions
1.Nab-paclitaxel(260mg/m2) Trastuzumab( 1st: 8mg/kg, 2nd: 6mg/kg) Pertuzumab (1st 840mg, 2nd 420mg) 4 courses (3qw) 2.Epirubicin (90mg/m2) Cyclophosphamide (600mg/m2) 4 courses (3qw)
Sponsors
Gifu University Graduate School of Medicine Department of Surgical Oncology
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 Kizawa memorial hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with breast cancer 2) HER2-type Luminal/HER2 type 3)Stage I-IIIB 4)Curable by neoadjuvant chemotherapy and surgery 5) cases with measurable lesion 6) age 20-69 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 12) To evaluate lymph node, not only CT/PET/US, but sentinel node biopsy/cytology may be preferable.
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 4 cycles of nabPTX/TZ/PER RDI Adjuvant therapy DFS OS Evaluation of TILs/SPARC in biopsy samples Analysis of tumor-rekated factors in urine and blood(Pre, after 4*nabPTX, after 4*EC) | — |
Countries
Japan
Contacts
Public ContactManabu Futamura
Gifu University Graduate School of Medinine Department of Surgical Oncology
Outcome results
None listed