Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
NCT ID: NCT01872260
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
255 participants
INTERVENTIONAL
2013-10-22
2027-02-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
NCT02734615
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
NCT02088684
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
NCT02154776
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
NCT01958021
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
NCT02941926
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LEE011 + letrozole Arm 1
LEE011 - 28 day cycles (21 days followed by a 7 day break - dose escalating), letrozole - 2.5 mg/day
LEE011
LEE011 - 28 day cycles (21 days followed by a 7 day break) for Arms 1, 3. LEE011 28 days cycles (continuous) Arm 4.
Letrozole
Letrozole 2.5 mg/day
BYL719 + letrozole Arm 2
BYL719 - daily (dose escalating) letrozole - 2.5 mg/day
Letrozole
Letrozole 2.5 mg/day
BYL719
BYL719 - 28 days cycle (continuous) for Arm 2; 3 and 4
LEE011 + BYL719 + letrozole Arm 3
LEE011 - 28 day cycles (21 days followed by a 7 day break -dose escalating), BYL719 - daily (dose escalating), letrozole 2.5 mg/day
LEE011
LEE011 - 28 day cycles (21 days followed by a 7 day break) for Arms 1, 3. LEE011 28 days cycles (continuous) Arm 4.
Letrozole
Letrozole 2.5 mg/day
BYL719
BYL719 - 28 days cycle (continuous) for Arm 2; 3 and 4
LEE011+ BYL719+letrozole Arm 4
LEE011-daily (dose escalating), BYL719 -daily (dose escalating), letrozole 2.5 mg/day
LEE011
LEE011 - 28 day cycles (21 days followed by a 7 day break) for Arms 1, 3. LEE011 28 days cycles (continuous) Arm 4.
Letrozole
Letrozole 2.5 mg/day
BYL719
BYL719 - 28 days cycle (continuous) for Arm 2; 3 and 4
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LEE011
LEE011 - 28 day cycles (21 days followed by a 7 day break) for Arms 1, 3. LEE011 28 days cycles (continuous) Arm 4.
Letrozole
Letrozole 2.5 mg/day
BYL719
BYL719 - 28 days cycle (continuous) for Arm 2; 3 and 4
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Phase Ib dose escalation only: Any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
* Phase Ib dose expansions Arms 1, 2 and 3
* No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
* Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment.
Exclusion Criteria
* Patients with active CNS or other brain metastases
* Major surgery within 2 weeks
* Acute or chronic pancreatitis
* Bilateral diffuse lymphangitic carcinomatosis
* Another malignancy within 3 years
* Receiving hormone replacement therapy that cannot be discontinued
* Impaired cardiac function
* Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dL / 7.0 mmol/L or hemoglobin A1c \>6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
18 Years
100 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of California at San Diego Moores Cancer Ctr
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Massachusetts General Hospital SC-5
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Ctr
Nashville, Tennessee, United States
Texas Oncology
Dallas, Texas, United States
Mays Cancer Ctr Uthsa Mdacc
San Antonio, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Saint-Herblain, , France
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Bellinzona, , Switzerland
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-509511-84-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLEE011X2107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.