OOTR-N006: mTOR inhibition with everolimus in invasive breast cancer patients after pre-operative use of anthracycline and/or taxane-based chemotherapy.

e12507Background: Inhibition of mTOR, a downstream mediator of the PI3K/AKT signaling pathway, is a significant anti-cancer approach in response to PI3K/AKT activation, as demonstrated clinically with everolimus in the BOLERO-2 study. mTOR inhibition could potentially reverse resistance caused by pTEN mutation/AKT activation to chemotherapeutic agents. Methods: In a randomised controlled pilot-study investigating signals involved in chemotherapy-resistance, 45 evaluable patients in Hong Kong and South Korea with pathologically confirmed invasive breast cancer, a tumour greater than 3 cm at diagnosis, and measurable residual disease after 1 to 2 lines of anthracycline- and/or taxane-based neo-adjuvant chemotherapy (NAT), were randomised 1:1 within 1 week of NAT completion to either undergo observation or receive 3 weeks of everolimus 10mg/d before surgery. Primary objective was to obtain biological samples and analyse biomarkers. Therefor, pre- and post-treatment tissue samples were analysed by Foundation ...