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.
Unknown status
N/A
Metastatic breast cancer is the leading cause of cancer-related death among women worldwide
,those overexpress the HER2 are associated with a higher risk. Lapatinib is approved for use
to treat advanced metastatic breast cancer. The pharmacokinetic parameters of lapatinib have
been characterized previously.It can reach steady state concentration after 6 or 7 days oral
dosing, but the bioavailability is very different between different patients. The effect of
food on lapatinib pharmacokinetics in humans was first examined in 19 healthy participants
who were given single 100-mg doses with a high-fat breakfast. Food caused a 60% increase in
the relative bioavailability of lapatinib.Another test showed that the bioavailability of
lapatinib was 3 times more in low-fat diet than in emptiness.
Some investigators think that it can change the mode for taking lapatinib with food or
without food to enhance the absorption.It may decrease the oral dose but the lapatinib can
reach the same steady state concentration,so it can achieve maximum economic benefits.
By continuous change for lapatinib and fat diet, The change of lapatinib pharmacokinetic is
lack of discussion. If the adverse reactions increase since the absorption of lapatinib
increase, the existing research data are still lacking.
The trial 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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| lapatinib administered with hight-fat breakfast | Experimental |
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
| Maximum Eligible Age: | 65 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
| Measure: | the Best Mode for Takeing Lapatinib |
| Time Frame: | 20 days |
| Safety Issue: | |
| Description: | 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 |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Sun Yat-sen University |
April 14, 2017
