Unresectable advanced or recurrent breast cancer
Conditions
Interventions
Eribulin mesylate administer day 1, day 8, tri-weekly interval. The trial treatment will be continued until there is progressive disease. we will evaluate the variation of eribulin pharmacokinetics at
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: a)Histological confirmation of invasive breast cancer b)Unresectable locally advanced cases (T4 case) or recurrent breast cancer c)It does not matter dosing history of anthracycline, taxane, vinca alkaloid agents, 5-FU-based anti-cancer agent (UFT, capecitabine, S-1). d)Patients with no treated with eribulin. e)Patients wit 75 years of age 20 years of age or older obtaining informed consent f)PS (ECOG) 0 to 2 g)Patients with passed for more than 2 weeks from prior treatment (chemotherapy, radiation therapy, hormon therapy). h)Patients with the following values in their latest laboratory tests -Neutrophil count > 1,000/mm3 -Platelet count > 75,000/mm3 -Hemoglobin > 9.0/dL -Serum AST/ALT < 5 x Upper Normal Limits -Serum creatinine < 1.5 mg/dL
Exclusion criteria
Exclusion criteria: a)Patients with brain metastases with symptoms b)Patients with the body cavity fluid marked (pleural effusion, ascites, pericardial effusion). However, it can be registered if good control due to the administration of adhesion agent. c)Patients with synchronous double cancer, not including lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy d)Patients with complications is determined causing serious problems in the implementation of treatment - Patients with poor control diabetes - Patients with activity infection - Patients with pulmonary fibrosis or interstitial pneumonia on chest X-ray - Patient with protocol difficult-to-treat caused by the mental state or neuropsychiatric disorders - Patients with watery diarrhea chronic - Patients with ileus, significant bleeding tendency, and gastrointestinal bleeding - Patients with uncontrolled angina and myocardial infarction and heart disease merger severe cases with heart failure that developed within three months e)Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Pharmacokinetic analysis of eribulin -Correlation between effectiveness/toxicity and pharmacokinetics of eribulin | — |
Countries
Japan
Contacts
Public ContactKenji Tamura
National Cancer Center Hospital Breast and Medical Oncology Division
Outcome results
None listed