Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer.
- Conditions
- metastatic breast cancer
- Registration Number
- JPRN-UMIN000015516
- Lead Sponsor
- CSPOR-BC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 138
Not provided
1) Overexpression of human epidermal growth factor receptor 2 (Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive. 2) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less). 3) Grade2 or greater peripheral neuropathy 4) Severe allergic history against medicines 5) Severe complications, e.g., lung fibrosis, interstitial pneumonitis, uncotrolable diabetes meritus, severe cardiac dysfunction, renal failure, liver failure, cerebral vascular disorder, ulcer requiring blood transfusion. 6) Concurrent active infections. 7) The presence of brain metastasis requiring treatment 8) Psychiatric disorder affecting to get informed consent 9) Physician concludes that the patient's participation in this trial is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival(PFS)
- Secondary Outcome Measures
Name Time Method time to treatment failure(TTF), overall survival (OS), response rate (RR), disease control rate (DCR), adverse events, PROs/HRQo