Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
NCT ID: NCT02154776
Last Updated: 2020-12-19
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
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2014-06-27
2016-10-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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LEE011 + buparlisib + letrozole
open label, dose escalation evaluating max tolerated dose of the triple combination
LEE011
3 weeks on and 1 week off
Buparlisib
daily
Letrozole
2.5 mg daily;
Interventions
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LEE011
3 weeks on and 1 week off
Buparlisib
daily
Letrozole
2.5 mg daily;
Eligibility Criteria
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Inclusion Criteria
2. Patient is postmenopausal.
3. Patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase.
4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
5. 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.
6. Patient must have either:
* Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion
Exclusion Criteria
2. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
* History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
* History of documented congestive heart failure (New York Heart Association functional classification III-IV)
* Documented cardiomyopathy
* Patient has a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
* History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
* On screening, any of the following cardiac parameters: bradycardia (heart rate \< 50 at rest), tachycardia (heart rate \> 90 at rest), PR interval \> 220 msec, QRS interval \>109 msec, or QTcF \>450 msec.
Systolic blood pressure \>160 or \<90 mmHg
3. Patient is currently receiving any of the following medications:
* That are known strong inducers or inhibitors of CYP3A4.
* That have a known risk to prolong the QT interval or induce Torsades de Pointes.
* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
4. Certain scores on an anxiety and depression mood questionnaires
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of California at Los Angeles UCLA SC
Los Angeles, California, United States
Horizon Oncology Center SC
Lafayette, Indiana, United States
Medical University of South Carolina SC
Charleston, South Carolina, United States
South Texas Accelerated Research Therapeutics SC
San Antonio, Texas, United States
University of Utah / Huntsman Cancer Institute SC-3
Salt Lake City, Utah, United States
Novartis Investigative Site
Madrid, , Spain
Countries
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Related Links
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Results for CLEE011A2112C can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLEE011A2112C
Identifier Type: -
Identifier Source: org_study_id