Breast Cancer relapsed after surgery
Conditions
Interventions
nab-paclitaxel
eribulin
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically proven breast cancer 2) relapsed after surgery 3) HER2 negative 4) patient with assessable lesion 5) prior peri-operative taxane 6) prior anthracycline 7) first- or second-line 8) appropriate period from prior therapy 21 days from chemotherapy 7 days from hormone therapy 14 days from radiotherapy 28 days from major surgery 14 days from minor surgery 9) PS (ECOG) 0-1 10) adequate organ function neutrophil>=1,500/mm3 platelet>=100,000/mm3 hemoglobin>=9.0 g/dL AST (GOT) <=100 IU/L (<=150 IU/L if liver metastases) ALT (GPT) <=100 IU/L (<=150 IU/L if liver metastases) T-Bil<=1.5 mg/dL serum Cr<=1.5 mg/dL SpO2>=94% (ambient air) 11) 20 years or older 12) Written informed consent 13) life expectancy>=90 days
Exclusion criteria
Exclusion criteria: 1) prior eribulin and/or nab-paclitaxel 2) taxane for metastatic disease 3) <6monthd from last taxane administration 4) Effusions (pleural, pericardial effusion, ascites) requiring treatment 5) brain metastasis requiring treatment 6) >=grade 2 peripheral sensory neuropathy (CTCAE ver4.0) 7) clinically abnormal ECG 8) systemic infection 9) severe diabetes mellitus 10) interstitial pneumonia/pulmonary fibrosis apparent on chest Xp 11) active double cancer 12) severe psychosis 13) systemic corticosteroid 14) severe drug allergy 15) hypersensitivity for paclitaxel and/or albumin 16) positive HBs antigen 17) pregnant or lactating woman 18) other causes judged ineligible by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, overall survival, and safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed