Neoplasms, Breast
Conditions
Keywords
lapatinib, breast cancer, treatment-naive
Brief summary
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.
Interventions
DRUGlapatinib
GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | subjects on study up to 15 days | biomarker analysis of tumor biopsies pre/post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | subjects on study up to 15 days | safety assessments of labs, hematology labs, Electrocardiogram, vital signs |
Countries
Israel, United States
Outcome results
None listed