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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Breast

Treatments: Drug: lapatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359190

EGF10027

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Lapatinib receivers

Experimental group

Description:

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..

Treatment:

Drug: lapatinib