Treatment Schedule
PD, tumor
DISEASE, TUMOR
Alisertib was administered as 50 mg, oral, twice daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle. Fulvestrant was administered as 500 mg, intramuscularly on days 1 and 15 of a 28-day cycle (cycle 1) and then day 1 of all subsequent cycles.Arm 1 patients experiencing progression of disease (PD) could crossover to arm 2 if (1) ER was 10%or greater positive in preregistration or PD tumor tissue; (2) recovery from toxic effects to grade 0 to 1; (3) adequate blood cell counts and chemistry results; and (4) treatment initiated within 35 days of PD.