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Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

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: NCT02941926
Recruitment Status : Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ribociclib Drug: Letrozole Drug: Goserelin Drug: Leuprolide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3256 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : September 5, 2019
Estimated Study Completion Date : May 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Ribociclib + letrozole
Ribociclib oral (3 weeks on/1 week off) in combination with oral once daily letrozole: 600 mg ribociclib QD + 2.5 mg letrozole QD
Drug: Ribociclib
Ribociclib oral (3 weeks on/1 week off) in combination with oral once daily letrozole: 600 mg ribociclib QD + 2.5 mg letrozole QD
Other Name: LEE011

Drug: Letrozole
Ribociclib oral (3 weeks on/1 week off) in combination with oral once daily letrozole: 600 mg ribociclib QD + 2.5 mg letrozole QD

Drug: Goserelin
Only for men and premenopausal women: administered as an injectable subcutaneous implant once every 28 days

Drug: Leuprolide
Only for men and premenopausal women: administered as an injectable intramuscular depot once every 28 days




Primary Outcome Measures :
  1. The number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to approximately 36 months ]
    AEs, Grade 3/4 AEs & SAEs during treatment with ribociclib + letrozole


Secondary Outcome Measures :
  1. Time-to-Progression (TTP) [ Time Frame: Up to approximately 36 months ]
    Time to progression (TTP) is defined as time from date of start of treatment to the date of event defined as the first documented progression or death due to underlying cancer.

  2. Overall response rate (ORR) for patients with measurable disease [ Time Frame: Up to approximately 36 months ]
    Overall response rate (ORR) is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

  3. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 36 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 an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1.

  4. Patient Reported Outcome (PRO) using scores from FACT-B questionaire [ Time Frame: Up to approximately 36 months ]
    FACT-B questionnaire will be used to collect patient reported outcome data in this trial. Descriptive statistics will be used to summarize the subscale and overall scores at each scheduled assessment time point. Additionally, change from baseline at the time of each assessment will be summarized. PRO data may be summarized by country/region.


Other Outcome Measures:
  1. The number of participants with adverse events as a measure of safety and tolerability during Extension Phase [ Time Frame: Up to approximatley 30 months ]
    Frequency and severity of AEs and SAEs

  2. Percentage of patients with clinical benefit during Extension Phase [ Time Frame: Up to approximately 30 months ]
    Clinical benefit is assessed by investigator



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  • In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.

    1. Postmenopausal status is defined either by:

      I). Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). 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. If patient is taking tamoxifen or toremifene and age < 60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range.

      Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure menopausal status.

    2. Premenopausal status is defined as either:

      I). Patient had last menstrual period within the last 12 months, OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.

    3. Perimenopausal status is define as neither premenopausal nor postmenopausal Note: Throughout this document, perimenopausal and premenopausal status is grouped together and referred as "Premenopausal"
  • 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 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.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):

    • Absolute neutrophil count ≥ 1.5 × 10^9/L
    • Platelets ≥ 100 × 10^9/L
    • Hemoglobin ≥ 9.0 g/dL
    • Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
    • INR ≤1.5
    • Serum creatinine <1.5 mg/dl or creatinine clearance≥50 mL/min
    • In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN.
    • Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
  • Patient must have a 12-lead ECG with ALL of the following parameters at screening:

    • QTcF interval at screening <450 msec (using Fridericia's correction)
    • Resting heart rate ≥ 50 bpm

Exclusion Criteria:

  • Patient who received any CDK4/6 inhibitor
  • Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted

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 study entry.
  • Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
  • Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic disease must be stopped at least 5 half-lives or 7 days, whichever is longer, before study inclusion.

    • Patient is concurrently using other anti-cancer therapy.

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): NCT02941926


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Locations
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United States, Alaska
Alaska Cancer Research & Education Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
Arizona Oncology Associates
Phoenix, Arizona, United States
Arizona Oncology Associates Arizona Oncology Assoc. (2)
Tucson, Arizona, United States, 85745
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Pacific Shores Medical Group SC
Long Beach, California, United States, 90813
USC Norris Cancer Center
Los Angeles, California, United States, 90033
University of California Irvine UC Irvine (11)
Orange, California, United States, 92868
Ventura County Hematology and Oncology
Oxnard, California, United States, 93030
PCR Oncology
Pismo Beach, California, United States, 93449
California Pacific Medical Center Onc Dept
San Francisco, California, United States, 94120-7999
United States, Colorado
Centura Health Research Center Centura Health Research Center
Denver, Colorado, United States, 80210
Poudre Valley Hospital Poudre Valley Health System
Fort Collins, Colorado, United States, 80528
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, United States, 81601
United States, Florida
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, United States, 33328
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States, 33021
Watson Clinic Center for Research 1730 Location
Lakeland, Florida, United States, 33805
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
United States, Georgia
Summit Cancer Care Summit Cancer Care (SC)
Savannah, Georgia, United States, 31405
John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
Thomasville, Georgia, United States, 31792
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, United States, 60612
Joliet Oncology-Hematology Associates Presence Cancer Center
Joliet, Illinois, United States, 60435
Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
Normal, Illinois, United States, 61761
Alpha Med Physician Group, LLC
Tinley Park, Illinois, United States, 60487
United States, Indiana
Indiana University Health Goshen Center for Cancer SC
Goshen, Indiana, United States, 46526
Northwest Oncology
Munster, Indiana, United States, 46321
United States, Iowa
June E. Nylan Cancer Center
Sioux City, Iowa, United States, 51101
United States, Kansas
University of Kansas Cancer Center University of Kansas Med Ctr 9
Kansas City, Kansas, United States, 66160
Sarah Cannon at Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66209
United States, Louisiana
John Ochsner Heart and Vascular Institute Clinical Trials
New Orleans, Louisiana, United States, 70121
United States, Maine
Mercy Oncology / Hematology Center SC
Portand, Maine, United States, 04102
United States, Maryland
Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
Baltimore, Maryland, United States, 21204-6831
Maryland Oncology Hematology, P.A. Columbia
Rockville, Maryland, United States, 20850
Kaiser Permanente
Rockville, Maryland, United States, 20879
Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
Washington DC, Maryland, United States, 20037
United States, Mississippi
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
United States, Nebraska
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, United States, 68506
Nebraska Cancer Specialists Oncology Hematology West
Omaha, Nebraska, United States, 68154
United States, Nevada
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey, United States, 07652
Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
Somerset, New Jersey, United States, 08873
United States, New Mexico
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87106
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
Clinical Research Alliance
Lake Success, New York, United States, 11042
United States, North Carolina
Oncology Speciialists of Charlotte
Charlotte, North Carolina, United States, 28207
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
The Christ Hospital Cancer Center Research Program Linder Research Center
Cincinnati, Ohio, United States, 45219
University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cleveland Clinic (5)
Cleveland, Ohio, United States, 44195
Dayton Physicians
Kettering, Ohio, United States, 45409
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute SC-2
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Oregon Health and Science University SC-5
Portland, Oregon, United States, 97239
United States, South Carolina
McLeod Center for Cancer Treatment and Research
Florence, South Carolina, United States, 29506
Carolina Blood and Cancer Care of South Carolina
Rock Hill, South Carolina, United States, 29732
United States, Texas
Oncology Consultants Oncology Consultants
Houston, Texas, United States, 77024
Millennium Oncology Millennium Oncology - FL
Houston, Texas, United States, 77090
Millennium Oncology
Houston, Texas, United States, 77090
Cancer Therapy & Research Center UT Health Science Center
San Antonio, Texas, United States, 78229
Hope Cancer Center of East Texas
Tyler, Texas, United States, 75701
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
PeaceHealth St Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Medical Centre of Everett
Everett, Washington, United States, 98201
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Valley Medical Center Research Valley Medical Center
Renton, Washington, United States, 98055
Virginia Mason Medical Center-Oncology SC
Seattle, Washington, United States, 98101
Northwest Medical Specialties Dept.ofNW Med. Specialties
Tacoma, Washington, United States, 98405
United States, Wisconsin
Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
Milwaukee, Wisconsin, United States, 53211
United States, Wyoming
Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
Cheyenne, Wyoming, United States, 82001
Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1125ABD
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1426ANZ
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000KZE
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San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
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La Rioja, Argentina, 5300
Austria
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Innsbruck, Tyrol, Austria, 6020
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Graz, Austria, 8036
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Leoben, Austria, A 8700
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Linz, Austria, 4010
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Rankweil, Austria, A-6830
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Salzburg, Austria, 5020
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Vienna, Austria, 1090
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Vienna, Austria, A-1090
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Wien, Austria, A-1130
Belgium
Novartis Investigative Site
Sint Niklaas, Vlaams Brabant, Belgium, 9100
Novartis Investigative Site
Antwerp, Belgium, 2020
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Bonheiden, Belgium, 2820
Novartis Investigative Site
Brugge, Belgium, 8000
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Brussels, Belgium, BE-B-1200
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1000
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Charleroi, Belgium, 6000
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Hasselt, Belgium, 3500
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Luxembourg, Belgium, 1210
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Mons, Belgium, 7000
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Namur, Belgium, 5000
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Roeselare, Belgium, 8800
Novartis Investigative Site
Verviers, Belgium, 4800
Novartis Investigative Site
Wilrijk, Belgium, 2610
Bulgaria
Novartis Investigative Site
Sofia, Sofia-Grad, Bulgaria, 1784
Novartis Investigative Site
Gabrovo, Bulgaria, 5300
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Plovdiv, Bulgaria, 4004
Novartis Investigative Site
Sofia, Bulgaria, 1303
Novartis Investigative Site
Sofia, Bulgaria, 1527
Novartis Investigative Site
Sofia, Bulgaria, 1606
Novartis Investigative Site
Sofia, Bulgaria, 1756
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4N2
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Novartis Investigative Site
Kelowna, British Columbia, Canada, V1Y 5L3
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Surrey, British Columbia, Canada, V3V 1Z2
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Novartis Investigative Site
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Novartis Investigative Site
Barrie, Ontario, Canada, L4M 6M2
Novartis Investigative Site
Cambridge, Ontario, Canada, N1R 3G2
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Hamilton, Ontario, Canada, L8V 5C2
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Kingston, Ontario, Canada, K7L 5P9
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Kitchener, Ontario, Canada, N2G 1G3
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London, Ontario, Canada, N6A 4G4
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Newmarket, Ontario, Canada, L3Y 2P9
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North York, Ontario, Canada, M2K1E1
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Oshawa, Ontario, Canada, L1G 2B9
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Ottawa, Ontario, Canada, KIH 7W9
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Sault Ste Marie, Ontario, Canada, P6B 0A8
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Sudbury, Ontario, Canada, P3E 5J1
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Toronto, Ontario, Canada, M3M 0B2
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2H1
Novartis Investigative Site
Laval, Quebec, Canada, H7M 3L9
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1M5
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Montreal, Quebec, Canada, H4A 3J1
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Montreal, Quebec, Canada, H4J 1C5
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Novartis Investigative Site
Regina, Saskatchewan, Canada, S4T 7T1
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
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Quebec, Canada, G1S 4L8
Chile
Novartis Investigative Site
Santiago, Chile, 8420383
Czechia
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Brno, Czech Republic, Czechia, 656 53
Novartis Investigative Site
Liberec, Czech Republic, Czechia, 46063
Novartis Investigative Site
Prague 8, Czech Republic, Czechia, 180 00
Novartis Investigative Site
Zlin, Czech Republic, Czechia, 76275
Novartis Investigative Site
Hradec Kralove, CZE, Czechia, 500 05
Novartis Investigative Site
Olomouc, CZE, Czechia, 775 20
Novartis Investigative Site
Brno, Czechia, 625 00
Novartis Investigative Site
Ceske Budejovice, Czechia, 370 87
Novartis Investigative Site
Pardubice, Czechia, 532 03
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Prague 5, Czechia, 150 00
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Praha 10, Czechia, 100 34
Novartis Investigative Site
Praha 4, Czechia, 140 59
Novartis Investigative Site
Praha, Czechia, 12808
Denmark
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Novartis Investigative Site
Vejle, Denmark, 7100
Finland
Novartis Investigative Site
Helsinki, Finland, 00029
Novartis Investigative Site
Oulu, Finland, FIN-90220
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Tampere, Finland, FIN-33521
France
Novartis Investigative Site
Nice Cedex 2, Alpes Maritimes, France, 06189
Novartis Investigative Site
Dijon Cedex, Cote D Or, France, 21034
Novartis Investigative Site
Limoges cedex, Haute Vienne, France, 87000
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Saint-Cloud, Hauts De Seine, France, 92210
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Tours Cedex 9, Indre Et Loire, France, 37044
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Reims Cedex, Marne, France, 51056
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Albi, France, 81000
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Angers Cedex 02, France, 49055
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Avignon Cedex, France, 84082
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Besancon Cedex, France, 25030
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Bobigny Cedex, France, 93009
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Bordeaux Cedex, France, 33000
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Bordeaux, France, 33076
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Caen Cedex, France, 14021
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Clermont-Ferrand, France, 63011
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Colmar Cedex, France, 68024
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Corbeil Essonnes, France, 91100
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Creteil, France, 94010
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Le Mans Cedex, France, 72015
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Lille Cedex, France, 59020
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Limoges, France, 87000
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Lyon Cedex 08, France, 69373
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Lyon Cedex, France, 69373
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Marseille, France, 13273
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Mont de Marsan cedex, France, 40024
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Montpellier Cedex 5, France, 34298
Novartis Investigative Site
Montpellier, France, 34070
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Nancy, France, 54000
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Nantes Cedex, France, 44277
Novartis Investigative Site
Neuilly sur Seine, France, 92200
Novartis Investigative Site
Paris Cedex 13, France, 75651
Novartis Investigative Site
Paris, France, 75010
Novartis Investigative Site
Paris, France, 75012
Novartis Investigative Site
Paris, France, 75231
Novartis Investigative Site
Paris, France, 75970
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Pierre Benite, France, 69310
Novartis Investigative Site
Plerin Sur Mer, France, 22190
Novartis Investigative Site
Périgueux Cédex, France, 24004
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Reims, France, 51100
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Rouen Cedex 1, France, 76038
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Saint Herblain cedex, France, 44805
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Strasbourg Cedex, France, 67010
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Strasbourg Cedex, France, 67091
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Toulon La Seyne Sur Mer, France, 83056
Novartis Investigative Site
Troyes, France, 10003
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Vandoeuvre-les-Nancy cedex, France, 54519
Greece
Novartis Investigative Site
Ioannina, GR, Greece, 455 00
Novartis Investigative Site
Thessaloniki, GR, Greece, 54645
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Athens, Greece, 115 28
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Athens, Greece, 18547
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Athens, Greece, GR 115 22
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Athens, Greece, GR14564
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Patras, Greece, 265 00
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Thessaloniki, Greece, 540 07
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Pokfulam, Hong Kong
Hungary
Novartis Investigative Site
Budapest, Hungary, 1134
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Budapest, Hungary, H 1122
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Budapest, Hungary, H-1032
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Debrecen, Hungary, 4032
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Szeged, Hungary, 6725
India
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Hyderabad, Andhra Pradesh, India, 500 034
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Tamil Nadu, Chennai, India, 600035
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New Delhi, Delhi, India, 110092
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Admedabad, Gujarat, India, 380060
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Bangalore, Karnataka, India, 560 020
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Nashik, Maharashtra, India, 422 004
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Pune, Maharashtra, India, 411013
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Jaipur, Rajasthan, India, 302017
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Vellore, Tamil Nadu, India, 632 004
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Kolkata, West Bengal, India, 700160
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Delhi, India, 110 085
Israel
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Beer-Sheva, Israel, 8457108
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Haifa, Israel, 3525408
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Jerusalem, Israel, 91120
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Petach Tikva, Israel, 49100
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Ramat Gan, Israel, 5265601
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Tel Aviv, Israel, 6423906
Italy
Novartis Investigative Site
Alessandria, AL, Italy, 15100
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Ancona, AN, Italy, 60126
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L'Aquila, AQ, Italy, 67100
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Arezzo, AR, Italy, 52100
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Asti, AT, Italy, 14100
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Avellino, AV, Italy, 83100
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Bari, BA, Italy, 70124
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Bergamo, BG, Italy, 24127
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Treviglio, BG, Italy, 24047
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02941926     History of Changes
Other Study ID Numbers: CLEE011A2404
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HR-positive HER2-negative
advanced breast cancer
LEE011
ribociclib
letrozole
goserelin
CDK
CDK4
CDK6
CDK4/6
Phase IIIb
ER-positive
PR-positive
premenopausal
postmenopausal
men with advanced breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Leuprolide
Goserelin
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
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal