Breast cancer
Conditions
Interventions
eliblin mesylate 1.4mg/m2, day1,8, div Treatment is administered every 3 weeks until evidence of disease progression, unacceptable toxicity, patient refusal.
Sponsors
Kobe Breast Cancer Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)histlogically or cytologically confirmed breast cancer 2)HER2 negative recurrent breast cancer patients 3)with interval period of 4 weeks after post operative adjuvant chemotherapy, 2 weeks after endocrine therapy or radiation 4) with previous treatment by anthracyclin and taxan for perioperative chemotherapy and without chemotherapy after recurrence 5) with evaluable lesion by RECIST criteria 6) ECOG perfomance status 0-2 7) required baseline laboratory parameters (within 2 weeks before registration) WBC >3,000/mm3 neutrophil >1,500/mm3 Plt >10,000/mm3 Hb >9.0g/dL AST <2.5 times ULN and ALT <2.5 times ULN (<5.0 with liver metastasis) serum creatinine <1.5 time ULN 8) with life expectancy greater than 3 months 9) written informed consent was obtained
Exclusion criteria
Exclusion criteria: 1) serious complication or past history: with symptomatic heart failure, liver cirrhosis, psychological disorder treated by antipsychotic drug, ischemic heart disease within 6 months, etc 2) active infection 3) peripheral neuropathy greater than Grade 3 4) male breast cancer 5) pregnant or nursing women, women who like be pregnant 6) with doctors decision for exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, over all survival, safety | — |
Countries
Japan
Contacts
Public ContactYasushi Shigeoka
Yodogawa Christian Hospital Medical Oncology
Outcome results
None listed