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

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT00299286
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    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.
  • Lapatinib-Placebo — DRUG
    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.

Study Details

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 measuring K167 (a marker of proliferation) in breast tumours before and after a short treatment with lapatinib.

Key Dates

Start date
Jun 30, 2007
Status verified
Aug 2012
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib
    lapatinib oral 1500mg daily taken as 6 tablets as one dose 10-14 days presurgery
  • Placebo Comparator: Lapatinib-Placebo
    placebo comparator 6 tablets taken as one dose daily

Primary Outcome Measure

Changes in Ki67 after short term treatment with lapatinib. [ Time Frame: 11-14 days after treatment ]

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