Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer (NCT01872260)
A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Univ of California at San Diego Moores Cancer Ctr — San Diego, California
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (25 Sites)
- Univ of California at San Diego Moores Cancer Ctr — San Diego, California
- UCSF Medical Center — San Francisco, California
- H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- Massachusetts General Hospital SC-5 — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Tennessee Oncology — Nashville, Tennessee
- Vanderbilt University Medical Ctr — Nashville, Tennessee
- Texas Oncology — Amarillo, Texas
- Mays Cancer Ctr Uthsa Mdacc — San Antonio, Texas
- Northwest Medical Specialties — Tacoma, Washington
- Novartis Investigative Site — Westmead, New South Wales
- Novartis Investigative Site — Parkville, Victoria
- Novartis Investigative Site — Nedlands, Western Australia
- Novartis Investigative Site — Marseille,
- Novartis Investigative Site — Paris,
- Novartis Investigative Site — Saint-Herblain,
- Novartis Investigative Site — Pisa, PI
- Novartis Investigative Site — Seoul,
- Novartis Investigative Site — Madrid,
- Novartis Investigative Site — Madrid,
- Novartis Investigative Site — Seville,
- Novartis Investigative Site — Valencia,
- Novartis Investigative Site — Bellinzona,
- Novartis Investigative Site — Glasgow,
- Novartis Investigative Site — Manchester,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.