Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Study Overview
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Brief Summary
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This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.

Official Title
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A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer

Conditions
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Neoplasms, Breast

Intervention / Treatment
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* Drug: lapatinib


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinical labs are within acceptable ranges. A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied. At least 18 years of age. Females must meet certain criteria specified in protocol. Ability to swallow and retain oral medication. Ability to follow and understand directions. Exclusion criteria: Female who is pregnant or lactating. Medically unfit by the doctor as a result of the medical interview or physicals. Received treatment of an investigational drug within 4 weeks of study start. Currently receiving treatment with prohibited meds listed in protocol. Had major surgery in previous 2 weeks. Had prior radiation therapy to the chest to treat this incidence of breast cancer. Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med. Has a malabsorption syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lapatinib receivers<br>Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection.. | Drug: lapatinib<br>* GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples. | biomarker analysis of tumor biopsies pre/post dose | subjects on study up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors. | safety assessments of labs, hematology labs, Electrocardiogram, vital signs | subjects on study up to 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lapatinib, breast cancer, treatment-naive