ECLIPSE: Preoperative immunotherapy combinations in breast cancer
Research type
Research Study
Full title
A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer.
IRAS ID
230866
Contact name
Peter Schmid
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2016-004424-38
Duration of Study in the UK
3 years, 0 months, 30 days
Research summary
Current standard options for the treatment of oestrogen receptor positive (ER+) breast cancer include chemotherapy and endocrine therapy. Despite all progress a substantial number of patients will still relapse and new treatment options are required to improve patient outcomes. Research has shown that tumours can evade destruction by the immune system by a range of different mechanisms. Over the last few years, significant developments around cancer immunotherapy (CIT) have led to a shift in the treatment of cancer. CIT refers to any treatment that modifies and/or enhances the patient’s immune system to fight cancers. Recent CIT studies have shown exceptional improvements in survival for a range of cancers, including types that are otherwise relatively resilient to systemic therapy such as melanoma. Early results with immune checkpoint inhibitors targeting programmed death-ligand 1 (PD-L1) or programmed death−1 (PD-1) have demonstrated encouraging activity in triple-negative breast cancer (TNBC) with durable responses and substantial survival in patients with metastatic breast cancer, but it remains unclear to what degree ER+ patients might benefit from CIT.
This trial will be carried out in approximately 160 women with early ER+ breast cancer in order to assess the effect that CIT combinations have on this type of cancer. Treatment will bridge the time between diagnosis and surgery and will be given for 3 weeks. To assess the effect of the treatment, breast cancer samples will be collected before treatment and on completion of treatment. Pre-treatment samples can be archived tissue but patients may require an additional biopsy if sufficient stored tumour tissue is not available. End of treatment biopsies will be taken during surgery, unless the patient is scheduled to receive medical treatment first, which might mean that additional biopsies will have to be collected. The study will be carried out in 5 countries.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1758
Date of REC Opinion
8 Nov 2017
REC opinion
Further Information Favourable Opinion