Resectable primary breast cancer
Conditions
Interventions
After 4 cycles of nab-Paclitaxel followed by 4 cycles of EC, surgical resection is carried out. nab-Paclitaxel (HER2 negative) nab-Paclitaxel 260mg/m2 iv day1 q3w (HER2 positive) nab-Paclitax
Sponsors
PerSeUS:Perpetual Study estimated-by United Sections in Gifu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed breast cancer 2)ER positive, HER2 negative and Ki-67 >=15 or Nuclear grade 3 ER positive and HER2 positive ER negative and HER2 positive Triple negative 3)Clinical stage I-IIIB 4)Radical cure by operation and neoadjuvant chemotherapy 5) With measurable lesions 6) Age between 20 and 69 years at registration 7) Performance status of 0 or 1 8) With no prior surgery, radiotherapy, chemotherapy and endocrine therapy for breast cancer 9) Normal LVEF (LVEF> 50%) measured by the MUGA scan or the echocardiogram (HER2 positive) 10) Adequate organ function shown in physical examinations within 14 days before the registration White blood cell count =>3000/mm3 Neutrophil count =>1500/mm3 Platelet count =>100000/mm3 Hemoglobin =>9.0g/dL AST<= 2.5 x ULN ALT <= 2.5 x ULN Total bilirubin <=1.5mg/dL Creatinine <=1.5mg/dL Adequate cardiac function 11) Patient who undertook sentinel lymph node biopsy, if any 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Inflammatory, bilateral or mucinous breast cancer 2) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval 3) Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular disease, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis. 4) Active infection 5) Interstitial pneumonitis or pulmonary fibrosis identified by chest radiography or chest CT 6) Positive for HBs antigen or HCV antibody 7) Uncontrollable peripheral neuropathy 8) History of drug allergy 9) Pregnant / nursing 10) Severe mental disorders 11) Disqualified by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate pCR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Histological therapeutic effect Safety Breast conserving rate QOL | — |
Countries
Japan
Contacts
Public ContactManabu Futamura
Gifu University graduate school of medicine Breast and molecular oncology
Outcome results
None listed