Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

Lapatinib

"In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).~Lapatinib tablets are dispensed as 250mg tablets. Patients should be advised to take all 6 tablets at once as one dose (total daily dose 1500mg). Tablets should be taken on an empty stomach either one hour before or one hour after a meal at the same time each day and according to the instructions on the bottle."

DRUG

Lapatinib-Placebo

"In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).~Lapatinib-placebo tablets will be composed of lactose, cellulose, starch, magnesium stearate, and coated with Opadryl orange and look the same as the active treatment. The patients should take all 6 tablets at once as one dose."

Trial Locations (1)

Unknown

Royal Marsden NHS Foundation Trust, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Institute of Cancer Research, United Kingdom

OTHER