Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
- Conditions
- advanced or metastatic breast cancer
- Registration Number
- JPRN-UMIN000010945
- Lead Sponsor
- Mitsui Memorial Hospital Department of Breast Endocrine Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 9
Not provided
1)Received a taxane within 6 months in neoadjuvant or adjuvant chemotherapy before study treatment 2)Received chemotherapy for metastatic breast cancer (more than one regimen) 3)Pre-treatment paclitaxel, docetaxel, nab-paclitaxel for metastatic breast cancer 4)Received endocrine therapy within 1 week of the study treatment 5)Received irradiation within 2 weeks of the study treatment 6)Received surgery within 4 weeks of the study treatment 7)With symptomatic brain metastases 8)With grade2 or grater peripheral neuropathy, myalgia, arthralgia 9)Requiring pleural effusion, peritoneal effusion, pericardial effusion by drain 10)Undergoing (oral or intravenous) systemic continuous steroids administration 11) With serious complications (active infection, pulmonary fibrosis, diabetes, heart disease, renal failure, hepatic failure, B hepatitis, C hepatitis, HIV, etc.) 12) With a history of hypersensitivity for nab-paclitaxel, paclitaxel, albumin , cyclophosphamide and undergoing pentostatin administration, with serious bone marrow suppression, infectious diseases 13)With active double cancer 14) Pregnant or possibility of pregnant 15)Patients judged by the investigator as unfit to be enrolled in the study the study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine maximum tolerated dose and recommended dose
- Secondary Outcome Measures
Name Time Method