ECLIPSE

orange__line

A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer (ECLIPSE).

This is an international, open label, window of opportunity phase II trial that its primary objective is to determine whether adding immune-modulatory agents to atezolizumab increases the probability of an immune response over atezolizumab alone in women with untreated, histologically confirmed, operable, ER+, HER2-negative breast cancer (by 2-fold Increase in GzmB+ CD8+ T cell levels from baseline to end of treatment sample). Sample size is 160 patients.

Eligible patients will be randomised with an approximately equal ratio (1:1:1:1) to one of four treatment arms (three experimental arms: (1) Atezolizumab + Cobimetinib, (2) Atezolizumab + Ipatasertib, (3) Atezolizumab + Cobimetinib + Bevacizumab and a control arm: Atezolizumab alone.

Patients will receive treatment for 3 weeks prior to surgery or neoadjuvant therapy. Thereafter, patients will either be considered for definitive surgery or primary medical treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician.

NAME TUMOR TYPE TITLE PHASE N SITES COUNTRY STATUS
ECLIPSE
Legal Study Sponsor is Queen Mary University of London
Breast A phase II study investigating preoperative combination strategies for immunotherapy in patients with untreated, operable ER+, HER2-negative primary breast cancer (ECLIPSE) II 160 20-25 United Kingdom, Germany, Spain,South Korea Study start-up in Spain. Approval obtained in UK and UK sites activated.