Phase I trial to evaluate the addition of alisertib to fulvestrant in women with endocrine-resistant, ER+ metastatic breast cancer.
Tufia C HaddadAntonino D'AssoroVera SumanMateusz OpyrchalPrema PeethambaramMinetta C LiuMatthew P GoetzJames N InglePublished in: Breast cancer research and treatment (2017)
In patients with endocrine-resistant, ER+ MBC, alisertib in combination with fulvestrant was well tolerated. A favorable safety profile was observed. The RP2D is 50 mg twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle with standard dose fulvestrant. Promising antitumor activity was observed, including activity among patients with prior progression on fulvestrant.