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

Stopped early · Phase 2

Conditions studied: Early Breast Cancer

In brief

This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.

Key facts

Study ID

NCT01919229

Run by

Novartis Pharmaceuticals

People needed

14

Starts

2013-10-01

Expected to finish

2014-09-01

Last updated by the study team

2016-01-01

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group SC — Fayetteville, Arkansas, United States
• University of California at Los Angeles UCLA SC — Los Angeles, California, United States
• Massachusetts General Hospital SC-9 — Boston, Massachusetts, United States
• University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8) — Houston, Texas, United States
• Novartis Investigative Site — Singapore, Singapore, Singapore
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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