Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Not Applicable
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000008848
- Lead Sponsor
- Hiroshima Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
*Her2 positive *Prior administration of gemcitabine *Pulmonary fibrosis or pneumonitis *Abnormal cardiac function, myocardial infarction within 6 months *Body cavity fluid which needs to treatment *Active infection *Severe complicated situation *Severe drug allergic reaction *Serious psychiatric illness *After bone marrow transplantation *After stem cell transplantation *Symptomatic systemic brain metastasis *Active double cancer *Double chemotherapy *Pregnancy, breast feeding, suspected pregnancy
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 adverse events time to progression