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Evaluation of safety and efficacy of eribulin for patients advanced or recurrent HER2 negative breast cancer who have been treated with anthracyclines and taxanes

Not Applicable
Conditions
Breast cancer
Registration Number
JPRN-UMIN000007121
Lead Sponsor
Kyushu Breast Cancer Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1 ineligible patients complicated with infectious diseases or who suspected infectious diseases with fever 2. diarrheal , ileus 3. GI bleeding 4.severe drug allergy 5. severe renal and/ or liver dysfunction 6.significant interstitial pneumonia or pulmonary fibrosis by chest radiograph 7.pleural effusion, peritoneal effusion 8.poorly controlled hypertension or diabetes mellitus 9.maintenance therapy with systemic corticosteroids 10.pregnant women or women with suspected pregnancy 11.patients who received blood transfusion, blood products or G-CSF within 7 days prior to this study 12.presence of the active other malignancies 13.severe psychiatric disorder 14 brain metastases 15.patients judged by the investigator to be unfit for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
overall response rate
Secondary Outcome Measures
NameTimeMethod
duration of response progression- free survival overall survival
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