WT1-AS15-BRS-001(Neoadjuvant Breast Cancer Study_Protocol 113172)

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled, Phase I/II Study evaluating the safety, immunogenicity and clinical activity of neoadjuvant treatment with WT1-A10+ AS15 Antigen-Specific Cancer Immunotherapeutic in combination with standard therapy in patients with WT1-positive Stage II or III breast cancer

• IRAS ID

  60260

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2010-019909-42

• Research summary

  This randomized, placebo-controlled study aims to evaluate the safety and the immune response elicited by a new anti-cancer treatment; WT1 antigen specific cancer immunotherapeutic (WT1-ASCI), in conjunction with standard neoadjuvant treatment (the use of another form of treatment before surgery) for breast cancer.Patients with Stage II/III breast cancer, who express WT1- antigen would be eligible.Currently neoadjuvant chemotherapy or endocrine therapy is recommended for patients with breast cancer. The standard choice of neoadjuvant treatment is based on the hormone receptor and HER2 (a protein that can affect the growth of cancer cells) status of the tumour. Patients will be recruited in three parallel cohorts (Cohort A, B and C) according to the standard neoadjuvant treatment they will receive.The tumour antigen used in this study is called WT1 (Wilms?? tumour gene, no. 1). It is thought that by injecting the WT1, the immune system gets trained to destroy cancer cells that make WT1. The ASCI also contains an ??adjuvant? which is a mixture of natural and synthetic substances that increase the response of the immune system.Previous studies suggest WT1 expression in approximately half of breast cancers and an association with poor disease-free survival. This study will be conducted in a stepwise approach. In Phase 1 segment, the vaccine will be given to 15 patients from each Cohort. If there are no safety concerns and if the ASCI induces an adequate immune response, this cohort will proceed to the Phase II segment, where a total of 60 patients will be recruited in each Cohort.Patients will receive six or eight administrations of ASCI/placebo vaccine at three-week intervals, maximum duration is 26 or 32 weeks, according to the standard treatment regimen. Patients will be followed up for 6 years after the last study treatment.The recruitment period will be 24 months. The study is being conducted in specialist Centres globally.

• REC name

  Scotland A REC

• REC reference

  11/AL/0324

• Date of REC Opinion

  18 Aug 2011

• REC opinion

  Further Information Favourable Opinion