A Short-Term Presurgical Study to Assess the Molecular Predictors of the Antiproliferative Effects of Lapatinib (GW572016) in Primary Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 3, 2006

Last Updated Date

October 10, 2006

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00299286 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Short-Term Presurgical Study to Assess the Molecular Predictors of the Antiproliferative Effects of Lapatinib (GW572016) in Primary Breast Cancer

Official Title ^†

Brief Summary

To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative effects of laptinib in breast cancer, ie how much lapatinib slows down the growth of cancer cells by measuring K167 (a marker of proliferation) in breast tumours before and after a short treatment with lapatinib.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^†

Breast Cancer

Intervention ^†

Drug: lapatinib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

120

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients must have a histological or cytologic diagnosis of primary breast cancer with a tumour size adequate for multiple core biopsie Informed signed consent Scheduled for primary surgery Expected to be compliant for duration of study Age<80 ECOG performance status 0-2 (Krnofsky >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 Co-ordinator The effects if lapatinib on the develpoing foetus 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 Criteria:

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 hormaonal replacement therapy within 4 weeks of study entre.

Regular use of steriod hormones or other agents that could influence study endpoints History of allergic reactions attributed to compounds of similar chemical or bologic composition to GW572016.

Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.

Gender

Both

Ages

up to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00299286

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Royal Marsden NHS Foundation Trust

Collaborators ^††

Investigators ^†

Principal Investigator:

Professor Ian Smith

Royal Marsden NHS Foundation Trust

Information Provided By

Royal Marsden NHS Foundation Trust

Verification Date

January 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.