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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: hight-fat breakfast

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fei Xu, MD; Phone Number: 13711277870; Email: xufei@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Fei Xu, Degree; Phone Number: 87342693; Email: xufei@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: lapatinib administered with hight-fat breakfast	Other: hight-fat breakfast; It's divided into two stages.For the first stage,the subjects take lapatinib on an empty stomach,the steady state plasa concentration is examined on the 9th and 10th days after lapatinib is administered.The second stage,the subject take lapatinib with hight-fat breakfast,the steady state plasa concentration is examined as the first stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2017
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 5, 2017
• First Posted (ACTUAL): March 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: lapatinib; steady state plasma concentration; high-fat breakfast
• Other Study ID Numbers: SYSU002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No