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.
Chief Investigator: Prof P. Schmid
Trial contact: email@example.com
Clinical Trials.gov: NCT02216786
Sponsor: Queen Mary University of London
Participating countries: UK, Spain, Portugal, Germany, South Korea, France, Hungary, Romania, Georgia
Source of funding: AstraZeneca UK Ltd (funding and study drug)
MANTA - 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. Peter Schmid, M Zaiss, C Harper-Wynne, et al. Cancer Res (2018) 78(4 Supplement), GS2-07-GS2-07. doi:10.1158/1538-7445.SABCS17-GS2-07
Cancer Research UK website A trial of fulvestrant with vistusertib or everolimus for advanced breast cancer (MANTA)