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

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

Study Details

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.

Key Dates

Start date

Jun 29, 2004

Status verified

Nov 2017

Primary completion

Jan 9, 2008

Completion

Jan 9, 2008

Study Design

Enrollment

28 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib receivers
  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..

Primary Outcome Measure

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. [ Time Frame: subjects on study up to 15 days ]

Locations (8)

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