A phase II trial of early phase eribulin for metastatic breast cancer.
Not Applicable
Recruiting
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000010334
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with infection or fever 2)History of severe allergy 3)History of renal or liver failure 4)Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray 5)Patients with pleural effusion of ascites that needs to be treated 6)Patients with hypertention or diabetes that are not controlled by medication 7)Administration of systemic steroids 8)Pregnancy 9)Patients who had transfusion or injection of G-CSF within 7 days before the treatment 10)Other active malignancies 11)Clinically significant mental disorder 12)CNS involvement 13)Participants of other treatment protocol 14)Other medical conditions that could limit a patient's ability to undertake study therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method objective response rate
- Secondary Outcome Measures
Name Time Method progression free survival, overall survival, safety