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Double-blind short term pre-surgical study to assess the molecular antiproliferative predictors of lapatinib’s effects in breast cancer.

Disease site: Breast cancer

Treatment modality: Other

Status: Closed

Trial details

The aim of the MAPLE study is to evaluate changes in biological characteristics, using a known molecular marker responsible for tumour growth (Ki67). Lapatinib has shown promising anti-tumour activity in breast cancer and targeting this drug to the most appropriate subset of breast cancer patients in the future will depend on a full understanding of the molecular determinants of response.

Women presenting with a breast lump were considered for inclusion in the MAPLE study. Following confirmation of diagnosis and consent, research samples taken at diagnostic biopsy were compared with those taken at main surgery and following a two week course of treatment (lapatinib or lapatinib-placebo in a 3:1 ratio). The trial opened in July 2007 and recruited 121 patients. 

Chief Investigator: Professor Stephen Johnston, Royal Marsden NHS Foundation Trust

ICR-CTSU Scientific Lead:Professor Judith Bliss

Trial management contact: [email protected]

ISRCTN: 68509377

Sponsor: The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research

Funding: Cancer Research UK (CRUKE/06/039) & GlaxoSmithKline

Publications and presentations

Evans A, Leary A, Johnston S, A'Hern R, Bliss JM, Hills M, Harper-Wynne C, Bundred N, Coombes G, Sahoo R, Detre S, Smith I, Dowsett M. Lapatinib has antiproliferative effects in both HER2 positive (+) and HER2 negative (-) breast cancer (BC): results from the MAPLE short-term pre-surgical trial (CRUK E/06/039). Proc of AACR Annual Meeting 2012:#LB222

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.