Trial Design: International, double-blind, placebo-controlled, randomised phase II trial of paclitaxel plus AZD5363 (capivasertib) versus paclitaxel plus placebo in patients with triple-negative advanced or metastatic breast cancer. Randomisation was stratified by the number of metastatic sites and prior (Neo)Adjuvant chemotherapy. Treatment with capivasertib /Placebo was continued until disease progression. Paclitaxel treatment will be continued for at least 6 cycles unless there disease progression. After that point patients entered a survival follow up phase.
PAKT met its primary endpoint and study result were reported as an oral abstract at ASCO 2018. Patients continue to be in follow up. Based on the success of this academically led phase II trial, capivasertib is now in the process of being tested in a large phase III randomised trial.
Chief Investigator: Prof P. Schmid
Trial contact: firstname.lastname@example.org
Clinical Trials.gov: NCT02423603
Sponsor: Queen Mary University of London
Participating countries: UK, South Korea, France, Hungary, Romania, Georgia
Source of funding: AstraZeneca UK Ltd (funding and study drug)
AZD5363 plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (PAKT): A randomised, double-blind, placebo-controlled, phase II trial. Peter Schmid, Jacinta Abraham, Stephen Chan, et al. Journal of Clinical Oncology (2018) 36:15_suppl, 1007-1007