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Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) (MONALEESA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01958021
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Results First Posted : May 12, 2017
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a multi-center, randomized, double-blinded, placebo controlled trial.

Condition or disease Intervention/treatment Phase
Advanced, Metastatic Breast Cancer Drug: LEE011 Drug: Letrozole Drug: LEE011 Placebo Phase 3

Detailed Description:
The primary purpose of this study was to assess the efficacy of LEE011, as measured by progression free survival (PFS), in postmenopausal women with HR positive, HER2 negative advanced breast cancer who received no prior treatment for advanced disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Actual Study Start Date : December 17, 2013
Actual Primary Completion Date : January 29, 2016
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: LEE011 + letrozole
LEE011 (Ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
Drug: LEE011
Ribociclib was administered orally at a dose of 600 mg once daily (three 200 mg capsules).

Drug: Letrozole
Letrozole 2.5 mg tablets taken orally.

Placebo Comparator: Placebo + letrozole
Matching ribociclib placebo was the control drug and was administered orally once daily.
Drug: Letrozole
Letrozole 2.5 mg tablets taken orally.

Drug: LEE011 Placebo
Matching ribociclib placebo was the control drug and was administered orally once daily.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) Per Investigator Assessment [ Time Frame: Up to approximately 20 months ]
    PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) as Per Investigator Assessment [ Time Frame: Up to approximately 20 months ]
    Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 65 months ]
    Time from date of randomization to the date of death from any cause.

  3. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 20 months ]
    Clinical Benefit Rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.

  4. Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score [ Time Frame: Up to approximately 20.5 months ]
    Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.

  5. Safety and Tolerability of LEE011 [ Time Frame: Up to approximately 21 months ]
    Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.

  6. Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 20 months ]
    The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.

  7. QTc Interval [ Time Frame: Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1 ]
    Time between the start of the Q wave and the end of the T wave corrected for heart rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  2. Patient is postmenopausal. Postmenopausal status is defined either by:

    • Prior bilateral oophorectomy
    • Age ≥60
    • Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial.
  3. No prior systemic anti-cancer therapy for advanced disease.
  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 (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented).

    OR

    • If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (Patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation).

  7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  1. Patient who received any CDK4/6 inhibitor.
  2. Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer

    Note:

    • Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization.
    • Patients who received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible.
    • Any prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 half-lives or 7 days, whichever is longer, before randomization
  3. Patient is concurrently using other anti-cancer therapy.
  4. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  5. 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

    6. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior start if the treatment:

  • 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.
  • Herbal preparations/medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958021


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Locations
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United States, Alabama
Clearview Cancer Institute Onc Dept
Huntsville, Alabama, United States, 35805
United States, Arizona
Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States, 85224
Arizona Oncology Associates PC HAL
Sedona, Arizona, United States, 86336
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
NEA Baptist Cancer Center
Jonesboro, Arkansas, United States, 72401
United States, California
Alta Bates Cancer Center Oncology Dept.
Berkeley, California, United States, 94704
City of Hope National Medical Center SC-5
Duarte, California, United States, 91010 3000
Glendale-Adventist Medical Center Dept of Oncology
Glendale, California, United States, 91206
Beaver Medical Group, L.P.
Highland, California, United States, 92346
The Angeles Clinic and Research Institute SC-3
Los Angeles, California, United States, 90025
Cedars Sinai Medical Center SC-5
Los Angeles, California, United States, 90048
UC Davis Comprehensive Cancer Center SC-2
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado School of Medicine Onc Dept.
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
United States, Florida
University Cancer Institute SC
Boynton Beach, Florida, United States, 33426
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, United States, 33328
Florida Cancer Specialists FL Cancer Specialists
Fort Myers, Florida, United States, 33901
Memorial Hospital SC
Hollywood, Florida, United States, 33021
University of Miami Univ Miami 2
Miami, Florida, United States, 33136
Florida Cancer Institute SC-3
Orlando, Florida, United States, 32804
Florida Cancer Institute SC-5
Orlando, Florida, United States, 32804
Sacred Heart Medical Oncology SC
Pensacola, Florida, United States, 32504
Florida Cancer Specialists - North
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Georgia Cancer Specialists Georgia Cancer Spec
Decatur, Georgia, United States, 30033
Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. Onc Dept
Thomasville, Georgia, United States, 31792
United States, Hawaii
Moanalua Medical Center. Attn: Oncology Dept
Honolulu, Hawaii, United States, 96817
United States, Illinois
University of Illinois Cancer Center at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Dept. of Oncology
Chicago, Illinois, United States, 60637
North Shore University Health System
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital Ingalls Mem Hosp
Harvey, Illinois, United States, 60426
Edward Hospital Dept of Oncology
Naperville, Illinois, United States, 60540
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med SC-3
Baltimore, Maryland, United States, 21231
Frederick Memorial Hospital SC
Frederick, Maryland, United States, 21701
United States, Massachusetts
Tufts Medical Center SC
Boston, Massachusetts, United States, 02111
Dana Farber Cancer Institute Dana Farber-9
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute Onc. Dept.
Detroit, Michigan, United States, 48201
United States, Minnesota
Virginia Piper Cancer Institute, Allina Health
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
United States, Missouri
Saint Luke's Hospital/Marion Bloch Neuroscience Institute Oncology Dept
Kansas City, Missouri, United States, 64111
Mercy Medical Research Institute SC-1
Manchester, Missouri, United States, 63021
United States, New Hampshire
Foundation Medical Partners
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Hackensack Meridian Health
Brick, New Jersey, United States, 08724
Cooper Cancer Center Cooper Cancer Center
Camden, New Jersey, United States, 08103
Regional Cancer Care Associates Regional Cancer Care
Cherry Hill, New Jersey, United States, 08003
Cancer Institute of New Jersey Onc Dept
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Medical Center SC-8
Bronx, New York, United States, 10467
CR Wood Cancer Center
Glens Falls, New York, United States, 12801
Clinical Research Alliance
Lake Success, New York, United States, 11042
Winthrop University Hospital Onc Dept
Mineola, New York, United States, 11501
NYU Langone Medical Center CV Research center SC-2
New York, New York, United States, 10016
Mount Sinai School of Medicine SC
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center SC-8
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care Inc Oncology Hematology Care (3)
Cincinnati, Ohio, United States, 45242
The Ohio State University Comprehensive Cancer Center Ohio State-2
Columbus, Ohio, United States, 43221
United States, Oklahoma
Mercy Clinic Oklahoma Communities Mercy Oncology
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Lehigh Valley Hospital Onc Dept
Allentown, Pennsylvania, United States, 18103
Penn State University Milton S Hershey Medical Center SC-3
Hershey, Pennsylvania, United States, 17033
United States, South Dakota
Avera Cancer SC-2
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Research Institute SC-2
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center SC-4
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Texas Oncology P A SC-3
Dallas, Texas, United States, 75251
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Center for Cancer and Blood Disorders SC
Fort Worth, Texas, United States, 76104
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
Texas Oncology Houston Memorial City SC
Houston, Texas, United States, 77024
University of Texas MD Anderson Cancer Center UT MDAnderson
Houston, Texas, United States, 77030
Millennium Oncology SC
Houston, Texas, United States, 77090
Texas Oncology
McAllen, Texas, United States, 78503
Richardson Hematology Oncology Associates
Richardson, Texas, United States, 75082
Texas Oncology P A
San Antonio, Texas, United States, 78217
US Oncology P A
Tyler, Texas, United States, 75702
United States, Utah
Utah Cancer Specialists Utah Cancer Specialists (11)
Salt Lake City, Utah, United States, 84106
United States, Virginia
Virginia Cancer Specialists Fairfax Northern Virginia
Fairfax, Virginia, United States, 22031
Oncology and Hematology Associates of Southwest Virginia Inc
Salem, Virginia, United States, 24153
Shenandoah Oncology Shenadoah Oncology (2)
Winchester, Virginia, United States, 22601
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, United States, 98405
United States, Wisconsin
Dean Health System Onc Dept
Madison, Wisconsin, United States, 53717
Argentina
Novartis Investigative Site
San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
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Cordoba, Argentina, X5002AOQ
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La Rioja, Argentina, 5300
Australia, South Australia
Novartis Investigative Site
Kurralta Park, South Australia, Australia, 5037
Novartis Investigative Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Austria
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Salzburg, Austria, 5020
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Vienna, Austria, A-1100
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Wels, Austria, A-4600
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Wien, Austria, A-1090
Belgium
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Sint Niklaas, Vlaams Brabant, Belgium, 9100
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Hasselt, Belgium, 3500
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Leuven, Belgium, 3000
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Namur, Belgium, 5000
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Wilrijk, Belgium, 2610
Brazil
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Barretos, SP, Brazil, 14784 400
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Ribeirao Preto, SP, Brazil, 14048-900
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Sao Paulo, SP, Brazil, 01246 000
Novartis Investigative Site
Sao Paulo, SP, Brazil, 01317-002
Canada, British Columbia
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Burnaby, British Columbia, Canada, V5G 2X6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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Kitchener, Ontario, Canada, N2G 1G3
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montreal, Quebec, Canada, H2W 1T8
Canada
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Quebec, Canada, G1S 4L8
Czechia
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Brno Bohunice, Czech Republic, Czechia, 625 00
Novartis Investigative Site
Brno, Czech Republic, Czechia, 656 53
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Liberec, Czech Republic, Czechia, 46063
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Olomouc, CZE, Czechia, 775 20
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Chomutov, Czechia, 430 01
Denmark
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Aalborg, Denmark, DK 9000
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Aarhus, Denmark, DK-8000
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Copenhagen, Denmark, DK-2100
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Odense C, Denmark, DK 5000
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Roskilde, Denmark, 4000
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Vejle, Denmark, 7100
Finland
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Helsinki, Finland, 00029
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Turku, Finland, FIN-20520
France
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Nice Cedex 2, Alpes Maritimes, France, 06189
Novartis Investigative Site
Angers Cedex 02, France, 49055
Novartis Investigative Site
Avignon Cedex, France, 84082
Novartis Investigative Site
Besancon Cedex, France, 25030
Novartis Investigative Site
Bordeaux Cedex, France, 33000
Novartis Investigative Site
Creteil, France, 94000
Novartis Investigative Site
Le Mans Cedex, France, 72015
Novartis Investigative Site
Lyon Cedex, France, 69373
Novartis Investigative Site
Pierre Benite Cedex, France, 69495
Novartis Investigative Site
Rouen Cedex 1, France, 76038
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site
Villejuif Cedex, France, 94805
Germany
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Recklinghausen, North Rhine-westphalia, Germany, 45657
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Berlin, Germany, 14169
Novartis Investigative Site
Berlin, Germany, 14195
Novartis Investigative Site
Bielefeld, Germany, 33604
Novartis Investigative Site
Bonn, Germany, 53111
Novartis Investigative Site
Bottrop, Germany, 46236
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Erlangen, Germany, 91054
Novartis Investigative Site
Essen, Germany, 45136
Novartis Investigative Site
Freiburg, Germany, 79110
Novartis Investigative Site
Fuerth, Germany, 90766
Novartis Investigative Site
Goslar, Germany, 38642
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Muenchen, Germany, 80335
Novartis Investigative Site
Offenbach, Germany, 63069
Novartis Investigative Site
Ravensburg, Germany, 88214
Novartis Investigative Site
Tübingen, Germany, 72076
Novartis Investigative Site
Ulm, Germany, 89081
Novartis Investigative Site
Velbert, Germany, 42551
Hungary
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Kecskemet, Bacs Kiskun, Hungary, 6000
Novartis Investigative Site
Budapest, Hungary, 1134
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Budapest, Hungary, H 1122
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Debrecen, Hungary, 4032
Novartis Investigative Site
Gyor, Hungary, H-9023
Novartis Investigative Site
Gyula, Hungary, 5700
Novartis Investigative Site
Miskolc, Hungary, 3529
Novartis Investigative Site
Tatabanya, Hungary, 2800
Ireland
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Cork, Ireland
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Dublin 4, Ireland, 4
Israel
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Italy
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Brescia, BS, Italy, 25123
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Genova, GE, Italy, 16132
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Lecco, LC, Italy, 23900
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Macerata, MC, Italy, 62100
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Messina, ME, Italy, 98158
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Milano, MI, Italy, 20133
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Padova, PD, Italy, 35100
Novartis Investigative Site
Perugia, PG, Italy, 06129
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Pisa, PI, Italy, 56126
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Aviano, PN, Italy, 33081
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Reggio Calabria, RC, Italy, 89124
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Roma, RM, Italy, 00155
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Roma, RM, Italy, 00168
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Candiolo, TO, Italy, 10060
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Terni, TR, Italy, 05100
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Viterbo, VT, Italy, 01100
Novartis Investigative Site
Napoli, Italy, 80131
Korea, Republic of
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Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
Novartis Investigative Site
Gyeonggi do, Korea, Korea, Republic of, 10408
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Republic of, 03722
Lebanon
Novartis Investigative Site
Ashrafieh, Lebanon, 166830
Novartis Investigative Site
Beirut, Lebanon, 1107 2020
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Beirut, Lebanon
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Saida, Lebanon, 652
Netherlands
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Maastricht, AZ, Netherlands, 5800
Novartis Investigative Site
Alkmaar, Netherlands, 1815 JD
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site
Deventer, Netherlands, 7416 SE
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site
Groningen, Netherlands, 9728 NZ
Novartis Investigative Site
Hoofddorp, Netherlands, 2134 TM
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Leiden, Netherlands, 2300 RC
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Sittard-Geleen, Netherlands, 6162 BG
Novartis Investigative Site
Tilburg, Netherlands, 5042 AD
Novartis Investigative Site
Zwolle, Netherlands, 8025 AB
Norway
Novartis Investigative Site
Bergen, Norway, 5021
Novartis Investigative Site
Oslo, Norway, 0407
Russian Federation
Novartis Investigative Site
Arkhangelsk, Russian Federation, 163045
Novartis Investigative Site
Nizhniy Novgorod, Russian Federation
Novartis Investigative Site
Ryazan, Russian Federation, 390011
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
South Africa
Novartis Investigative Site
Pretoria, Gauteng, South Africa, 0081
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08024
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Novartis Investigative Site
Madrid, Spain, 28009
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28046
Sweden
Novartis Investigative Site
Eskilstuna, Sweden, SE-631 88
Novartis Investigative Site
Goteborg, Sweden, 413 45
Novartis Investigative Site
Joenkoeping, Sweden, 551 85
Novartis Investigative Site
Lund, Sweden, 221 85
Novartis Investigative Site
Uppsala, Sweden, SE-751 85
Novartis Investigative Site
Vaxjo, Sweden, SE-351 85
Taiwan
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan, 33305
Novartis Investigative Site
New Taipei City, TWN, Taiwan, 23561
Novartis Investigative Site
Kaohsiung, Taiwan, 80756
Novartis Investigative Site
Taichung City, Taiwan, 407
Novartis Investigative Site
Taipei, Taiwan, 10048
Novartis Investigative Site
Taipei, Taiwan, 11217
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10330
Novartis Investigative Site
Bangkok, Thailand, 10400
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06590
Novartis Investigative Site
Diyarbakir, Turkey, 21000
Novartis Investigative Site
Istanbul, Turkey, 34303
Novartis Investigative Site
Izmir, Turkey, 35040
United Kingdom
Novartis Investigative Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01958021     History of Changes
Other Study ID Numbers: CLEE011A2301
2013-003084-61 ( EudraCT Number )
First Posted: October 8, 2013    Key Record Dates
Results First Posted: May 12, 2017
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HR-positive
HER2-negative
Advanced breast cancer
LEE011
Letrozole
CDK
CDK4
CDK6
CDK4/6
Phase III
ER-positive
PR-positive
Postmenopausal

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs