ETROZOLE versus LETROZOLE PLUS LAPATINIB GW572016 IN HORMONE-SENSITIVE, HER-2 NEGATIVE OPERABLE BREAST CANCER. A DOUBLE BLIND RANDOMIZED PHASE II STUDY WITH BIOMARKER EVALUATION - LAP107692 - LETLOB

• Conditions: Primary breast cancer hormone-sensitive in postmenopausal women; MedDRA version: 6.1Level: PTClassification code 10057654

• Registration Number: EUCTR2006-001907-13-IT
• Lead Sponsor: GLAXO SMITH KLINE RESEARCH DEVELOPMENT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-03
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

- Histologically confirmed infiltrating primary breast cancer of 2.0 cm 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 61619; 60 years of age 60 years of age and amenorrheic for 61619; 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 61472;3000/ 61549;L absolute neutrophil count 61472;1,500/ 61549;L platelets 61472;100,000/ 61549;L 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 in Section 3.7.4.2 Other concomitant treatments. - Ability to understand and the willingness to sign a written informed consent document. - Ability to swallow and retain oral medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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 - HIV-positive patients receiving combination anti-retroviral therapy - 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To estimate the percentage of clinical objective responses cOR complete plus partial, measured by USG in the breast;Secondary Objective: - To estimate the percentage of pathological complete responses pCR in the breast and axillary nodes - To estimate the percentage of conservative surgery - To assess the safety profile of the combination of hormonal treatment plus lapatinib - To evaluate the time to treatment failure from start of primary therapy - To evaluate the percentage of inhibition of intermediate and final biomarkers of the proliferative and the apoptosis pathways induced by the hormonal treatment plus lapatinib or placebo - To evaluate the correlation between tumor gene expression at diagnosis and pathological response in the two treatment arms.;Primary end point(s): percentage of clinical objective responses cOR complete plus partial, measured by USG