To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet

Sun Yat-sen University

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: hight-fat breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT03075995

SYSU002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

lapatinib administered with hight-fat breakfast

Experimental group

Treatment:

Other: hight-fat breakfast