Condition category
Cancer
Date applied
28/07/2006
Date assigned
12/09/2006
Last edited
04/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Johnston

ORCID ID

Contact details

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

04/05/2016: Publication reference added.