A double-blind short-term presurgical study to assess the molecular predictors of the antiproliferative effects of lapatinib in women with primary breast cancer

ISRCTN	ISRCTN68509377
DOI	https://doi.org/10.1186/ISRCTN68509377
ClinicalTrials.gov number	NCT00299286
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Stephen Johnston
Scientific

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Study design	Randomised double-blind/placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	MAPLE
Study objectives	To assess changes in Ki67 and molecular markers following a short pre-surgical course of lapatinib.
Ethics approval(s)	Ethics approval pending as of 12/09/2006
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Lapatinib versus placebo in a ratio of 3:1.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/10/2006
Completion date	01/10/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	120
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2007

Royal Marsden Hospital

London
SW3 6JJ
United Kingdom

Royal Marsden Hospital and the Institute of Cancer Research (UK)
Hospital/treatment centre

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
England
United Kingdom

"ROR"	https://ror.org/034vb5t35

Industry

GlaxoSmithKline
Government organisation / For-profit companies (industry)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No

04/05/2016: Publication reference added.