Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000005982
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Not provided
1) Allergy of nab-paclitaxel, albumin or paclitaxel 2) Serious complication 3) Synchronous or metachronous (within 5 years) double cancers 4) Abnormal ECG 5) Congestive heart failure, coronary artery diseases, uncontrollable arrhythmia or past history of myocardial infarction or angina pectoris within 6 months 6) Relapsed within 12 months (or during its treatment) after taxane-based neoadjuvant and adjuvant chemotherapy. Resistant to taxane-based neoadjuvant chemotherapy 7) Fully recovered from surgical within 4 weeks before registration 8) Received radiotherapy or neoadjuvant and adjuvant chemotherapy within 3 weeks before registration 9) Received endocrine therapy within 2 weeks before registration 10) Received ratiotherapy for more than 30% of hematopoietic bone marrow 11) Peripheral neuropathy grade 2 or greater 12) Active infection 13) Symptomatic brain metastasis 14) Un-controlled pleural effusion and ascites 15) Long-term corticosteroid therapy 16) Mental disorder 17) Pregnancy, breast feeding or wish of future bearing 18) Patients considered inappropriate by the study investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method