Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

Completed · Phase 1

Conditions studied: Advanced or Metastatic Breast Cancer

In brief

This is a multi-center, open-label, non-randomized, phase I study

Key facts

Study ID

NCT02154776

Run by

Novartis Pharmaceuticals

People needed

13

Starts

2014-06-27

Expected to finish

2016-10-26

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.
• Patient is postmenopausal.
• Patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase.
• Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
• 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.
• 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

You may not qualify if…

• Patient who received any CDK4/6 or PI3K inhibitor.
• 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
• 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.
• Certain scores on an anxiety and depression mood questionnaires

Where it is running

• 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

Full record on ClinicalTrials.gov

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