Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed infiltrating primary breast cancer of 2.0 cm or more in largest clinical diameter
ER and/or PgR positive cancer (\> 10% of positive cancer cell assessed by IHC)
Postmenopausal status, defined by at least one of the following:
≥ 60 years of age \< 60 years of age and amenorrheic for ≥ 12 months prior to day 1 \< 60 years of age and amenorrheic for \< 12 months prior to day, or without a uterus: luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months
HER2 negative tumors (IHC 0-2+, or FISH negative)
Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
Age over 18 years
ECOG PS 0-1
Normal organ and marrow function as defined below:
leukocytes \> 3000/mL absolute neutrophil count \> 1,500/mL platelets \> 100,000/mL total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT)\< 2.5 X institutional upper limit of normal Creatinine within normal institutional limits
Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan.
Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator.
A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided
Ability to understand and the willingness to sign a written informed consent document.
Ability to swallow and retain oral medication.
You may not be if
Stage IIIB, IIIC, and inflammatory breast cancer
Stage IV breast cancer
Contraindication to the treatment with letrozole
Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies
Treatment with any other investigational agents, or with all herbal (alternative) medicines
History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors (See section 3.7.4.2 Other concomitant treatments)
