There are two studies currently looking for participants. If you are a woman with metastatic breast cancer, and your oncologist hasn’t mentioned the studies to you, bring it up with them. I know the studies are being done nationwide right now (fall 2013). I was expected to begin pre-trial base-line markers this month, but I am not in the studies, after all. More in next blog about that, but I wanted to get this information out to those interested.
One study, TKI1258 (TKI) is a multi-center, randomized, double-blind, placebo controlled, phase II trial. It’s being evaluated for the safety and efficacy of TKI in combination with fulvestrant – also known as Faslodex (a shot). The trial will be of post-menopausal women with Her2, and HR+ breast cancer that have evidence of disease progression on or after [one] prior endocrine therapy.
The other trial study, BKM120, is a phase III randomized, double-blind placebo controlled study with BKM120 with fulvestrant. The participants will be post-menopausal women with hormone receptor positive or Her2-negative, locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment.
There is expected to be 150 TKI and 1,060 BKM participants in the multi-center studies in the USA. Both studies are by the pharmaceutical company Novartis. The hospital where I go was looking for five patients for each study. If you’re interested in the study, look into it. It may take them a while to find matches.
Talk with your oncologist. Good luck!