MANTA

Title: A randomized Phase II study of Fulvestrant in combination with the dual mTOR inhibitor AZD2014 or Everolimus or Fulvestrant alone in Estrogen receptor-positive advanced or metastatic breast cancer

Disease site: Breast cancer

Status: Closed

Trial Design: Open-label, multicentre, four arm randomised phase II trial of fulvestrant + AZD2014 (vistusertib) at a continuous daily schedule and fulvestrant + vistusertib at an intermittent schedule versus fulvestrant + everolimus versus fulvestrant alone. MANTA enrolled patients with oestrogen receptor positive, HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment with (or within 12 months after discontinuation of) an aromatase inhibitor in the adjuvant setting or progressed during treatment with an aromatase inhibitor in the metastatic setting. Patients were randomised (2:3:3:2) to one of the four treatment arms and randomisation was stratified by measurable disease and sensitivity to prior endocrine therapy. Treatment was given  until disease progression at which point patients entered survival follow up.  The study will also assess the relationship between the anticipated anti-tumour activity of the treatment regimen and biological characteristics of patients’ tumour at baseline.

MANTA met its primary endpoint and study result were reported as an oral abstract at the 2017 San Antonio Breast Cancer Symposium. Patients continue to be in follow up.