Clareo Health | Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.
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
You may not be if
1. Patient who received any CDK4/6 or PI3K inhibitor.
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
