Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00299286
Protocol/serial number
N/A
Study information
Scientific title
A double-blind short-term presurgical study to assess the molecular predictors of the antiproliferative effects of lapatinib in women with primary breast cancer
Acronym
MAPLE
Study hypothesis
To assess changes in Ki67 and molecular markers following a short pre-surgical course of lapatinib.
Ethics approval
Ethics approval pending as of 12/09/2006
Study design
Randomised double-blind/placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Lapatinib versus placebo in a ratio of 3:1.
Intervention type
Drug
Phase
Not Applicable
Drug names
Lapatinib
Primary outcome measure
Changes in Ki67 after short term treatment with lapatinib
Secondary outcome measures
Assess how changes in Ki67 and apoptosis relate to molecular markers at baseline and after two weeks
Overall trial start date
01/10/2006
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All female patients under 80 years of age who present with a breast lump
2. Have a histological diagnosis of breast cancer on biopsy
3. Are scheduled for primary surgery
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of zero to two
5. Have a cardiac ejection fraction within the normal range as measured by echocardiogram (ECG)
6. Have an adequate bone marrow function, serum creatine and bilirubin with normal limits
7. Are able to swallow and retain oral medication
8. Have given written informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Prior malignancy
2. Evidence of metastatic disease
3. Use of hormonal therapy within four weeks
4. Receiving other investigational agents
5. Systemic steroid therapy
6. Uncontrolled inter-current illness including significant ECG abnormality
Recruitment start date
01/10/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden Hospital
London
SW3 6JJ
United Kingdom
Funders
Funder type
Industry
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://cancerres.aacrjournals.org/cgi/content/short/72/8_MeetingAbstracts/LB-222?rss=1
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25398453