Phase I trial of Albumin-bound paclitaxel plus Cyclophosphamide for metastatic breast cancer
Phase 1
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000006597
- Lead Sponsor
- Shiga University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1) allergy of the nab-paclitaxel, paclitaxel or albumin 2) allergy of the medication 3) HER2 positive confirmed by IHC 3+ or FISH+ 4) During pregnancy or lactation 5) Severe infectious disease 6) Clinically significant heart disease 7) Uncontrollable pleural effusion or ascites requiring 8) Symptomatic brain metastasis 9) with active another cancer 10) Peripheral neuropathy grade 2 or greater 11) with pulmonary fibrosis or pneumonitis 12) Cases who physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determinate maximum tolerated dose and recommended dose
- Secondary Outcome Measures
Name Time Method