Results from a randomised, Phase II study involving 111 patients showed the proportion of metastatic breast cancer patients without tumor progression at six months was 61.1% for those receiving everolimus plus tamoxifen compared to 42.1% for patients treated with tamoxifen alone.
In the patients treated with the combination, the disease progression was delayed by a median of 8.6 months compared to 4.5 months in patients treated with tamoxifen alone, with everolimus plus tamoxifen providing a statistically significant reduction in the risk of disease progression by 47%, Novartis said.
Side-effects were generally manageable in both the arms, and the number of patient deaths (as of October 2010) in tamoxifen arm was 25 versus nine in the everolimus plus tamoxifen arm.
The randomised Phase II trial was designed to evaluate the efficacy and safety of everolimus in 111 patients with HR+/HER2- metastatic breast cancer with prior exposure to AI treatment (in adjuvant and/or metastatic setting), who were randomised in 1:1 ratio to receive everolimus plus tamoxifen or tamoxifen alone.
The primary endpoint of the study was clinical benefit rate, defined as complete response, partial response and stable disease (CR+PR+SD) at six months in the everolimus plus tamoxifen arm.