metastatic breast cancer
Conditions
Interventions
Abraxane 260mg/m2 (SD arm) every 21 days, until disease progression
Abraxane 220mg/m2 (MD arm) every 21 days, until disease progression
Abraxane 180mg/m2 (LD arm) every 21 days, until disease pr
Sponsors
CSPOR-BC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven breast cancer. 2) One of the following conditions has to be met for a diagnosis of metastatic breast cancer. * At presentation, the patients have distant metastasis. * The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post-operative treatment); however, local recurrence is excluded. 3) The presence of at least one measurable lesion. However, sites treated by radiotherapy are not considered assessable lesions. 4) Performance status (ECOG scale): 0-1 5) Age of 20-75 years. 6) Adequate major organ functions within 14 days before enrollment., as defined below: Neutrophil count < 3,000/mm3 Platelet count < 100,000/mm3 Hemoglobin < 9.0 g/dL AST < 100 U/L ALT < 100 U/L Total bilirubin < 1.5 mg/dL Serum creatinine < 1.5 mg/dL 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Overexpression of human epidermal growth factor receptor 2 (Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive. 2) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less). 3) Grade2 or greater peripheral neuropathy 4) Severe allergic history against medicines 5) Severe complications, e.g., lung fibrosis, interstitial pneumonitis, uncotrolable diabetes meritus, severe cardiac dysfunction, renal failure, liver failure, cerebral vascular disorder, ulcer requiring blood transfusion. 6) Concurrent active infections. 7) The presence of brain metastasis requiring treatment 8) Psychiatric disorder affecting to get informed consent 9) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| time to treatment failure(TTF), overall survival (OS), response rate (RR), disease control rate (DCR), adverse events, PROs/HRQoL | — |
Countries
Japan
Contacts
Public ContactHiromi Shinano
CSPOR-BC Secretariat
Outcome results
None listed