Status:
TERMINATED
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Early Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
Detailed Description
This randomized pre-surgical pharmacodynamics study will assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer.
Eligibility Criteria
Inclusion
- Female patient is ≥ 18 years old at the time of informed consent, with newly diagnosed resectable breast cancer, who received no prior therapy for breast cancer
- Patient is postmenopausal. Postmenopausal status is defined either by:
- Prior bilateral oophorectomy
- Age ≥60
- Age \<60 and amenorrhea for 12 or more months and FSH (Follicle Stimulating Hormone) and estradiol in the postmenopausal range.
- 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 a grade II or grade III invasive breast cancer
- Patient has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+ (if IHC 2+, a negative in situ hybridization (respectively FISH/CISH/SISH) test is required) by local laboratory testing
- Patient has at least one breast lesion with a diameter of ≥1.0 cm by the most accurate imaging modality used.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion
- Patient has received any prior therapy for breast cancer.
- Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal cell skin cancer or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- 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 ventricular, supraventricular, nodal arrhythmias, or any other cardiac arrhythmias, Long QT Syndrome or conduction abnormality in the previous 12 months.
- Family history of QTc prolongation or of unexplainable sudden death at \<50 years of age.
- On screening 12 lead ECG, 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 mmHg or \<90 mmHg.
- Patient is currently receiving any of the following medications (see
- Appendix 1 for details):
- That are known strong inducers or inhibitors of CYP3A4.
- That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
- That have a known risk to prolong the QT interval or induce Torsades de Pointes.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01919229
Start Date
October 1 2013
End Date
September 1 2014
Last Update
January 1 2016
Active Locations (7)
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1
Highlands Oncology Group SC
Fayetteville, Arkansas, United States, 72703
2
University of California at Los Angeles UCLA SC
Los Angeles, California, United States, 90095
3
Massachusetts General Hospital SC-9
Boston, Massachusetts, United States, 02114
4
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8)
Houston, Texas, United States, 77030-4009