Primary breast cancer
Conditions
Interventions
As adjuvant chemotherapy, 4 cycles of nab-paclitaxel 260 mg/m2(with or without Trastuzumab) every 3 weeks followed by 4 cycles of FEC (5-FU 500 mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2)
Sponsors
Kyushu Breast Cancer Study Group (KBC-SG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed breast cancer 2) Curatively resected 3) Age>=20 4) No more than 6 weeks since surgery 5) No prior therapy(except for surgery) 6) Performance status 0-1 7) Adequate function of important organs (within 14 days before registration) (1). WBC:>=4000/mm3 and <12,000 or Neutrophil:>=2,000/mm3 (2). Platelet:>=100,000/mm3 (3). Hemoglobin:>=9.0g/dL (4). T-Bil:<=1.5mg/dL (5). AST, ALT:<=ULNx2.0 (6). Creatinin:<=1.5mg/dL (7). UCG or MUGA scan, LVEF < 55% (8). ECG, within normal limit 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to paclitaxel and/or albumin 2) Metachronous bilateral breast cancer 3) Inflammatory breast cancer 4) Active double cancer 5) Other severe complications such as infectious diseases, diarrhea, intestinal palsy, intestinal obstruction, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months and heart failure 6) Pregnant and nursing female 7) Patients with pulmonary fibrosis or interstitial pneumonia 8) Sever bone marrow suppression, renal dysfunction, liver dysfunction 9) History of hypersensitivity reaction 10)Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completion rate of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, disease free survival, period until the onset of peripheral neuropathy and period to recovery, QOL related to peripheral neuropathy | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group (KBC-SG) Executive office
Outcome results
None listed