Status:
COMPLETED
Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief Summary
To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer cells by measur...
Detailed Description
Randomised multi centre double blind pre-surgical study in women with a histological diagnosis of breast cancer by core biopsy.
Eligibility Criteria
Inclusion
- Patients must have a histological or cytologic diagnosis of primary breast cancer with a tumour size adequate for multiple core biopsies Informed signed consent Scheduled for primary surgery Expected to be compliant for duration of study Age\<80 ECOG performance status 0-2 (Karnofsky \>60%) Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan Eligibility of patients receiving medications known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review by the Trial Coordinator The effects if lapatinib on the developing fetus are unknown. For this reason, women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of study participation.
- Able to swallow and retain oral medication.
Exclusion
- Patients with prior diagnosis of malignancy except in situ disease or basal cell carcinoma of the skin.
- Patients may be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded.
- Evidence of metastatic disease. Use of hormonal therapy such as oral contraceptives or hormonal replacement therapy within 4 weeks of study entry.
- Regular use of steroid hormones or other agents that could influence study endpoints History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00299286
Start Date
June 1 2007
End Date
August 1 2011
Last Update
August 6 2012
Active Locations (1)
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1
Royal Marsden NHS Foundation Trust
London, United Kingdom