A Multicenter Phase II Study of Tri-weekly Nab-Paclitaxel for Patients with Metastatic Breast Cancer Pretreated with Taxanes (SBCCSG-20)
Phase 2
- Conditions
- Primary breast cancer
- Registration Number
- JPRN-UMIN000005414
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group(SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1) Either of ER, PgR, HER2 is positive by surgical specimen. 2) Previously treated with Nab-paclitaxel. 3) Confirmed histologically HER2 positive. 4) History of serious allergy for paclitaxel or albumin 5) Serious complication. (intestinal paralysis, intestinal obstruction, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus) 6) Symptomatic brain metastasis 7) Active other malignancies 8) Severe psychiatric disorders 9) During pregnancy 10) Patients judged inappropriate by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate (DCR)
- Secondary Outcome Measures
Name Time Method Response rate Clinical benefit rate Progression free survival Time to treatment failure overall survival Safety