Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Safety and Tolerability of the combinations of LEE011 with fulvestrant, LEE011 + BKM120 with fulvestrant and LEE011 + BYL719 with fulvestrant

Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity

Time frame: 36 months

Plasma concentration-time profiles of LEE011, BKM120, BYL719 and fulvestrant.

To characterize the PK profiles of LEE011, BKM120, BYL719, and fulvestrant when used in combination as well as to evaluate any other clinically significant metabolites that may be identified. PK parameters for LEE011, BKM120 and BYL719, including but not limited to Cmax, Cmin, Tmax, AUCtau, accumulation ratio (Racc),and Ctrough values for fulvestrant.

Time frame: 36 months

Overall Response Rate (ORR)

ORR is defined as the proportion of patients with a best overall response of complete response or partial response.

Time frame: 36 months

Duration of Response (DOR)

Duration of Response is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer.

Time frame: 36 months

Progression Free Survival (PFS) (phase l only)

PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.

Time frame: 36 months

Overall Survival (OS) - Phase II only

OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive.

Time frame: 36 months