Safety trial of eriburin treatment to patient who has peripheral neuropathy

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21‐day cycle. CONDITION: Breast Cancer PRIMARY OUTCOME: Incidence rates of peripheral neuropathy G3(CTCAE) SECONDARY OUTCOME: Response Rate ; Overall Survival ; FACT‐NTX EQ‐5D; Safety; PNQ INCLUSION CRITERIA: 1) Histologically or cytologically confirmed breast cancer. 2) Unresectable metastatic breast cancer. 3)Previously treated with chemotherapeutic regimens including an anthracycline and a taxane first‐line chemotherapy 4)Having evaluable disease according to RECIST 5)Prior chemotherapy 0‐2 regimens for unresectable metastatic status 6)Having an adequate interval from prior therapy 1.chemotherapy:21days 2.endocrine therapy:7days 3.radiation therapy:14days 4.major surgery:28days 5.minor surgery:14days 6)PS (ECOG) 0‐2 7)Eligible patient for eribulin therapy 8)Peripheral neuropathy G1 or G0(experienced peripheral neuropathy caused from previous chemotherapy) 9)Adequate organ functions 1.neutrophil=>1000mm3 2.platelet count=>75000mm3 3.AST,ALT=<2.5 times ULN(<5.0 with liver metastasis) 4.total bilirubin=<1.5 times ULN serum creatinine=<1.5mg/dL 10)Female over 20 years old 11)Obta
Epistemonikos ID: 7ec82282a15f0360a085e437119cdcf94d588162
First added on: Aug 22, 2024