Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

Key inclusion criteria:

Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy.Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample, and all tested by local laboratory. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation). Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory:

QTcF interval at screening < 450 ms (QT interval using Fridericia's correction)Mean resting heart rate 50 to 90 bpm (determined from the ECG) Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization. Women of CBP must be willing to use highly effective methods of contraception.

Key