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TERMINATEDPHASE2

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

A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer

NCT01919229•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+6 more criteria

Locations (7)

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

Key Dates

Start Date

October 1, 2013

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

January 1, 2016

Enrollment

ACTUAL participants

Conditions

Early Breast Cancer

Interventions

LEE011 (ribociclib)

DRUG

letrozole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 1, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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