Clinical Trial: NCT01872260
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-09-18 |
Study Overview
Brief Summary
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).
This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4).
The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6.
Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.
Official Title
Conditions
Intervention / Treatment
- Drug: LEE011
- Drug: Letrozole
- Drug: BYL719
Other Study ID Numbers
- CLEE011X2107
- 2023-509511-84-00
- 2023
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2026-09-18 |
Study Overview
Brief Summary
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).
This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4).
The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6.
Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.
Official Title
Conditions
Intervention / Treatment
- Drug: LEE011
- Drug: Letrozole
- Drug: BYL719
Other Study ID Numbers
- CLEE011X2107
- 2023-509511-84-00
- 2023