Breast Cancer Clinical Trial
Official title:
To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet
Food can make a big difference on the bioavailability of lapatinib in breast cancer patients,and fatty food can increase the lapatinib bioavailability.By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with fatty food.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | April 1, 2019 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Advance breast cancer with her2 positive 2. The patients are ready to use or using lapatinib for tumor treatment, and plans to keep the treatment for at least a month 3. The ECOG score is 0 to 2 4. hemoglobin= 9 gm/dL 5. serum albumin concentration is normal 6. ALT / AST / bilirubin<1.5UL 7. creatinine clearance rate= 40 mL/min 8. signed ICF Exclusion Criteria: 1. Pregnancy or Pregnancy 2. Stomach absorption dysfunction 3. Difficulty in taking fatty food 4. Severe heart disease or medical condition |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the Best Mode for Takeing Lapatinib | by examined the steady state plasa concentration of Lapatinib ,determine which is the best way to take lapatinib,with high-fat breakfast or on an empty stomach | 20 days |
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