A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

Inclusion Criteria:

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 Criteria:

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