Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Phase 1
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000010125
- Lead Sponsor
- Tokyo-West Tokushukai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 6
Inclusion Criteria
Not provided
Exclusion Criteria
1) Inflammatory and bilateral breast cancer 2) HER2 positive confirmed by IHC or FISH 3) Active another cancer 4) History of hypersensitivity reaction 5) Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure 6) Neuropathy <= grade1 7) Radiation therapy for chest 8) Serious myelosuppression 9) Infection 10) Pregnant or possibility pregnancy or nursing woman 11) History of hypersensitivity for albumin 12) 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 Safety, Response rate