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 (NCT)	NCT00299286
Protocol serial number	N/A
Sponsor	Royal Marsden Hospital and the Institute of Cancer Research (UK)
Funder	GlaxoSmithKline

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

Primary study design	Interventional
Study design	Randomised double-blind/placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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. Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lapatinib
Primary outcome measure(s)	Changes in Ki67 after short term treatment with lapatinib
Key secondary outcome measure(s)	Assess how changes in Ki67 and apoptosis relate to molecular markers at baseline and after 2 weeks
Completion date	01/10/2007

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Female
Target sample size at registration	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
England

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

27/11/2025: The interventions were updated.
04/05/2016: Publication reference added.