LEE011 + BYL719 + Letrozole for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot be on hormone replacement therapy that cannot be discontinued. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Letrozole for breast cancer?
Is the combination of LEE011, BYL719, and Letrozole safe for humans?
What makes the drug combination of LEE011, BYL719, and Letrozole unique for breast cancer treatment?
The combination of LEE011 (a CDK4/6 inhibitor), BYL719 (a PI3K inhibitor), and Letrozole (an aromatase inhibitor) is unique because it targets multiple pathways involved in breast cancer cell growth, potentially offering a more comprehensive approach to treatment compared to using Letrozole alone.2591011
What is the purpose of this trial?
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.
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for postmenopausal women with advanced ER+/HER2- breast cancer who haven't had systemic treatment in the advanced setting, except possibly letrozole for up to one month. They can have had (neo)adjuvant therapy if they've been disease-free for over a year since completion. Exclusions include recent major surgery, other cancers within 3 years, heart issues, active brain metastases, and certain diabetes conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Phase Ib dose escalation to estimate the MTD and/or RP2D for the combinations
Dose Expansion
Phase Ib dose expansions to further characterize safety, tolerability, PK, and preliminary clinical anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BYL719
- LEE011
- Letrozole
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD