MAPLE

Disease site: Breast Cancer

Treatment Modality: Other

Status: Closed to recruitment

Double-blind short term pre-surgical study to assess the Molecular Antiproliferative Predictors of Lapatinib’s Effects in Breast Cancer.

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. Results are currently being analysed.

MAPLE is supported by the NCRI Breast Clinical Studies Group.