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Trial record 1 of 2 for:    NATALEE | United States
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A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03701334
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Translational Research in Oncology
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

Condition or disease Intervention/treatment Phase
Early Breast Cancer Drug: Ribociclib Other: Endocrine Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : May 29, 2026
Estimated Study Completion Date : May 29, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ribociclib

Arm Intervention/treatment
Experimental: Ribociclib + Endocrine Therapy
ribociclib 400 mg once daily on days 1-21 of a 28 day cycle followed by 7 days off" and endocrine therapy (ET) once daily continuously
Drug: Ribociclib
Ribociclib + ET

Other: Endocrine Therapy
Endocrine Therapy (ET)

Active Comparator: Endocrine Therapy
endocrine therapy (ET) only once daily continuously
Other: Endocrine Therapy
Endocrine Therapy (ET)




Primary Outcome Measures :
  1. Invasive Disease-Free Survival [ Time Frame: 44 months ]
    Invasive Disease-Free Survival for ribociclib + Endocrine Therapy versus Endocrine Therapy in patients with HR-positive, HER2-negative Early Breast Cancer using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator


Secondary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 44 months ]
    using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)

  2. Distant disease-free survival [ Time Frame: 44 months ]
    using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)

  3. Overall Survival [ Time Frame: 91 months ]
    overall survival

  4. Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30 [ Time Frame: 44 months ]
    The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  5. Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30 [ Time Frame: 44 months ]
    The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

  6. PK parameter Ctrough and other applicable parameters for ribociclib [ Time Frame: 44 months ]
    Pharmacokinetics of ribociclib when given in combination with Non-Steroidal Aromatase Inhibitor (and goserelin if applicable)



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:

  • Patient is ≥ 18 years-old at the time of PICF signature
  • Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.
  • Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
  • Patient has breast cancer that is positive for ER and/or PgR
  • Patient has HER2-negative breast cancer
  • Patient has available archival tumor tissue from the surgical specimen
  • Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: anatomic stage group II or III
  • If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
  • If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years

Exclusion Criteria:

  • Patient has received any CDK4/6 inhibitor
  • Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy.
  • Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
  • Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
  • Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
  • Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
  • Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
  • Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
  • Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization
  • Patient has known HIV infection, Hepatitis B or C infection
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
  • Patient is currently receiving any of the following substances within 7 days before randomization - Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
  • is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment
  • Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
  • Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial.
  • Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial

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): NCT03701334


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Alabama
University of Alabama at Birmingham/ Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35294-0006
Principal Investigator: Ahmed Elkhanany         
United States, Arizona
Cancer Treatment Centers of America Recruiting
Goodyear, Arizona, United States, 85338
Principal Investigator: Cynthia Lynch         
United States, Arkansas
St Bernards Medical Center Recruiting
Jonesboro, Arkansas, United States, 72401
Principal Investigator: Mazen Khalil         
United States, California
Comprehensive Blood and Cancer Center SC-2 Recruiting
Bakersfield, California, United States, 93309
Contact    661-616-1619      
Principal Investigator: Ravindranath Patel         
UCLA Beverly Hills Recruiting
Beverly Hills, California, United States, 90212
Contact    310-794-6500      
Principal Investigator: Nicholas McAndrew         
UCLA Burbank Recruiting
Burbank, California, United States, 91505
Principal Investigator: Nicholas McAndrew         
Encino Research Center Recruiting
Encino, California, United States, 91436
Principal Investigator: Nicholas McAndrew         
UCLA Hematology Oncology Recruiting
Laguna Hills, California, United States, 92653
Principal Investigator: Nicholas McAndrew         
Southern California Oncology Research Alliance SCORA Recruiting
Los Angeles, California, United States, 90057
Principal Investigator: Lasika Chandradatta Seneviratne         
UCLA Central Regulatory Recruiting
Los Angeles, California, United States, 90095
Contact    214-370-1000      
Principal Investigator: Nicholas McAndrew         
Valley Breast Care and Women s Health Center Recruiting
Los Angeles, California, United States, 91405
Principal Investigator: Thomas Lomis         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304-1509
Principal Investigator: George Sledge         
UCLA Pasadena Health Care Hematology Oncology Recruiting
Pasadena, California, United States, 941105
Principal Investigator: Nicholas McAndrew         
UCLA Porter Ranch Hematology and Oncology Recruiting
Porter Ranch, California, United States, 91326
Principal Investigator: Nicholas McAndrew         
Cancer Care Associates Medical Group Recruiting
Redondo Beach, California, United States, 90277
Contact    310-750-3300      
Principal Investigator: David Chan         
Sharp Memorial Hospital Regulatory Recruiting
San Diego, California, United States, 92123
Contact    858-939-5047      
Principal Investigator: Marie Shieh         
University of California San Francisco Gynecologic Oncology Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Melanie Majure         
Central Coast Medical Oncology Corporation Onc Dept Recruiting
Santa Maria, California, United States, 93454
Principal Investigator: Robert Dichmann         
UCLA Santa Monica Hematology / Oncology Regulatory-2 Recruiting
Santa Monica, California, United States, 90404
Contact    301-206-8309      
Principal Investigator: Nicholas McAndrew         
Lundquist Inst BioMed at Harbor Recruiting
Torrance, California, United States, 90509-2910
Principal Investigator: Nicholas McAndrew         
Gene Upshaw Memorial Tahoe Forest Cancer Cntr Withdrawn
Truckee, California, United States, 96161
UCLA Valencia Recruiting
Valencia, California, United States, 91355
Principal Investigator: Nicholas McAndrew         
Wellness Oncology Hematology TRM Withdrawn
West Hills, California, United States, 91307
UCLA Cancer Center, Westlake Village Recruiting
Westlake Village, California, United States, 91361
Principal Investigator: Nicholas McAndrew         
St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr Recruiting
Yorba Linda, California, United States, 92886
Contact    714-446-5900      
Principal Investigator: William Lawler         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Elena Shagisultanova         
Rocky Mountain Cancer Centers Recruiting
Greenwood Village, Colorado, United States, 80303
Principal Investigator: Jenny R Fox         
United States, Connecticut
Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06052
Principal Investigator: Wylie Hosmer         
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Kerin Adelson         
Norwalk Hospital Pulmonary Medicine Recruiting
Norwalk, Connecticut, United States, 06856
Contact    203-852-2045      
Principal Investigator: Linda Vahdat         
Eastern Connecticut Hematology and Oncology Associates Regulatory Recruiting
Norwich, Connecticut, United States, 06360
Principal Investigator: Jie Yang         
United States, Florida
Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01 Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact    954-229-8400      
Principal Investigator: Zdenka Segota         
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33901
Contact    239-274-9930      
Principal Investigator: Lowell Hart         
Memorial Cancer Institute Recruiting
Hollywood, Florida, United States, 33021
Principal Investigator: Aurelio Castrellon         
Baptist MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
Contact    614-657-1463      
Principal Investigator: Jennifer Crozier         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact    305-243-4090      
Principal Investigator: Frances Valdes Albini         
Orlando Health, Clinical Trials Orlando Health Inc Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Ana Elisa Cuesta Fernandez         
Florida Cancer Specialists - North Recruiting
Saint Petersburg, Florida, United States, 33705
Principal Investigator: Gail L Wright         
Florida Cancer Specialists Panhandle Recruiting
Tallahassee, Florida, United States, 32308
Principal Investigator: Viralkumar Bhanderi         
Florida Cancer Specialists- East Region Recruiting
West Palm Beach, Florida, United States, 33401
Principal Investigator: Sumithra Vattigunta         
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Joan Kramer         
Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
Contact    770-400-6629      
Principal Investigator: Damien Hansra         
United States, Illinois
Cancer Treatment Centers of America Recruiting
Zion, Illinois, United States, 60099
Principal Investigator: Dennis Citrin         
United States, Indiana
Fort Wayne Medical Oncology/Hematology, Inc. Withdrawn
Fort Wayne, Indiana, United States, 46815
Cancer Care Center Recruiting
New Albany, Indiana, United States, 47150
Principal Investigator: Ifeoma Okeke         
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact    913-588-0789      
Principal Investigator: Priyanka Sharma         
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214-3728
Contact    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact    +1 410 332 1200      
Principal Investigator: David Andrew Riseberg         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact    617-724-4000      
Principal Investigator: Aditya Bardia         
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Erin Cobain         
United States, Minnesota
Fairview Health Services Recruiting
Maple Grove, Minnesota, United States, 55369
Principal Investigator: Rebecca Thomas         
Metro Minnesota CCOP Metro Minneapolis CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact    952-892-7190      
Principal Investigator: Daniel Anderson         
Park Nicollet Institute Recruiting
Saint Louis Park, Minnesota, United States, 55416
Principal Investigator: Rachel Lerner         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact    816-932-2589      
Principal Investigator: Elizabeth Cathcart-Rake         
HCA Midwest Division Recruiting
Kansas City, Missouri, United States, 64132
Principal Investigator: Stephanie Graff         
David C Pratt Cancer Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact    314-251-7057      
Principal Investigator: Bethany G. Sleckman         
United States, Montana
St Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
Contact    406-238-6290      
Principal Investigator: Patrick Cobb         
United States, Nebraska
Saint Francis Medical Center Recruiting
Grand Island, Nebraska, United States, 68803
Contact    308-398-6518      
Principal Investigator: David Crockett         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89109
Principal Investigator: Stephani Christensen         
United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Principal Investigator: Anna Litvak         
United States, New York
Perlmutter Cancer Centre Recruiting
New York, New York, United States, 10016
Principal Investigator: Yelena Novik         
United States, North Carolina
Randolph Medical Associates Recruiting
Asheboro, North Carolina, United States, 27204
Principal Investigator: Vinay Gudena         
Alamance Regional Medical Cancer Center Recruiting
Burlington, North Carolina, United States, 27215
Principal Investigator: Vinay Gudena         
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact    336-832-1100      
Principal Investigator: Vinay Gudena         
United States, Oregon
Kaiser Permanente NW Region Recruiting
Clackamas, Oregon, United States, 97015
Principal Investigator: Abdul Hai Mansoor         
United States, Pennsylvania
Penn State Hershey Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact    +1 717 531 0003 Ext 285550      
Principal Investigator: Christina Truica         
Cancer Treatment Centers of America Eastern Regional Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact    215-537-7400      
Principal Investigator: Sramila Aithal         
United States, Tennessee
The West Clinic Recruiting
Germantown, Tennessee, United States, 38138
Contact    901-683-0055      
Principal Investigator: Lee S Schwartzberg         
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-329-7274      
Principal Investigator: Denise A Yardley         
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Joyce A O Shaughnessy         
Center for Cancer and Blood Disorders Research Department Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Robin Ruble Young         
MD Anderson Cancer Center/University of Texas Recruiting
Houston, Texas, United States, 77030
Contact    713-792-2817      
Principal Investigator: Vicente Valero         
USO Central Regulatory Recruiting
The Woodlands, Texas, United States, 77380
Principal Investigator: Neelima Denduluri         
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Principal Investigator: Stephan Kendall         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Neelima Denduluri         
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Principal Investigator: James L Khatcheressian         
United States, Washington
Seattle Cancer Care Alliance Medical Oncology Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Rachel Yung         
United States, Wisconsin
University of Wisconsin / Paul P. Carbone Comp Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact    608-265-2789      
Principal Investigator: Ruth Mary O Regan         
Argentina
Novartis Investigative Site Recruiting
Rosario, Santa Fe, Argentina, S2000
Novartis Investigative Site Recruiting
Rosario, Sante Fe, Argentina, S200KZE
Novartis Investigative Site Recruiting
San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
Novartis Investigative Site Recruiting
Rio Negro, Viedma, Argentina, 8500
Novartis Investigative Site Recruiting
Caba, Argentina, C1419AHN
Novartis Investigative Site Recruiting
Cordoba, Argentina, X5004FHP
Novartis Investigative Site Recruiting
Jujuy, Argentina, 4600
Novartis Investigative Site Recruiting
La Rioja, Argentina, 5300
Novartis Investigative Site Recruiting
Santa Fe, Argentina, 3000
Australia, New South Wales
Novartis Investigative Site Recruiting
Campbelltown, New South Wales, Australia, 2560
Novartis Investigative Site Recruiting
Coffs Harbour, New South Wales, Australia, 2450
Novartis Investigative Site Recruiting
Darlinghurst, New South Wales, Australia, 2010
Novartis Investigative Site Recruiting
Kingswood, New South Wales, Australia, 2747
Novartis Investigative Site Recruiting
Kogarah, New South Wales, Australia, 2217
Novartis Investigative Site Recruiting
Liverpool, New South Wales, Australia, 2170
Novartis Investigative Site Recruiting
North Ryde, New South Wales, Australia, 2109
Novartis Investigative Site Recruiting
St Leonards, New South Wales, Australia, 2065
Novartis Investigative Site Recruiting
Wahroonga, New South Wales, Australia, 2076
Novartis Investigative Site Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Novartis Investigative Site Recruiting
Auchenflower, Queensland, Australia, 4066
Novartis Investigative Site Recruiting
Birtinya, Queensland, Australia, 4575
Novartis Investigative Site Recruiting
Wooloongabba, Queensland, Australia, 4102
Australia, South Australia
Novartis Investigative Site Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Novartis Investigative Site Recruiting
Bendigo, Victoria, Australia, 3550
Novartis Investigative Site Recruiting
East Melbourne, Victoria, Australia, 3002
Novartis Investigative Site Recruiting
Epping, Victoria, Australia, 3076
Novartis Investigative Site Recruiting
Fitzroy, Victoria, Australia, 3065
Novartis Investigative Site Recruiting
Franston, Victoria, Australia, 3199
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Heidelberg, Victoria, Australia, 3084
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Melbourne, Victoria, Australia, 3000
Novartis Investigative Site Recruiting
Shepparton, Victoria, Australia, 3630
Australia, Western Australia
Novartis Investigative Site Recruiting
Murdoch, Western Australia, Australia, 6150
Novartis Investigative Site Recruiting
Nedlands, Western Australia, Australia, 6009
Austria
Novartis Investigative Site Recruiting
Graz, Styria, Austria, 8036
Novartis Investigative Site Recruiting
Innsbruck, Tyrol, Austria, 6020
Novartis Investigative Site Recruiting
Linz, Austria, 4020
Novartis Investigative Site Recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Recruiting
Wien, Austria, 1090
Belgium
Novartis Investigative Site Recruiting
Edegem, Antwerpen, Belgium, 2650
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1090
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Recruiting
Charleroi, Belgium, 6000
Novartis Investigative Site Recruiting
Hasselt, Belgium, 3500
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Recruiting
Libramont, Belgium, 6800
Novartis Investigative Site Recruiting
Liege, Belgium, 4000
Novartis Investigative Site Recruiting
Namur, Belgium, 5000
Novartis Investigative Site Recruiting
Wilrijk, Belgium, 2610
Novartis Investigative Site Recruiting
Yvoir, Belgium, 5530
Brazil
Novartis Investigative Site Recruiting
Londrina, PR, Brazil, 86015-520
Novartis Investigative Site Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
Novartis Investigative Site Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Novartis Investigative Site Recruiting
Porto Alegre, RS, Brazil, 90035-903
Novartis Investigative Site Recruiting
Porto Alegre, RS, Brazil, 90560-030
Novartis Investigative Site Recruiting
Porto Alegre, RS, Brazil, 90880-480
Novartis Investigative Site Recruiting
Barretos, Sao Paulo, Brazil, 14784 400
Novartis Investigative Site Recruiting
Santo Andre, SP, Brazil, 09060-650
Novartis Investigative Site Recruiting
Sao Paulo, SP, Brazil, 01317 000
Novartis Investigative Site Recruiting
Sao Paulo, SP, Brazil, 03102-002
Novartis Investigative Site Recruiting
Caxias do Sul, Brazil, 95070-560
Novartis Investigative Site Recruiting
Ijui, Brazil, 98700-000
Novartis Investigative Site Recruiting
Passo Fundo, Brazil, 99010-080
Novartis Investigative Site Recruiting
Piracicaba, Brazil, 13419-155
Novartis Investigative Site Recruiting
Recife, Brazil, 50040-000
Novartis Investigative Site Recruiting
Rio De Janeiro, Brazil, 20560-120
Novartis Investigative Site Recruiting
Salvador, Brazil, 41810 570
Novartis Investigative Site Recruiting
Sao Paulo, Brazil, 01255-000
Canada, Alberta
Novartis Investigative Site Recruiting
Calgary, Alberta, Canada, T2N 4N2
Novartis Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Novartis Investigative Site Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Novartis Investigative Site Recruiting
North Vancouver, British Columbia, Canada, V7L 2L7
Novartis Investigative Site Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Novartis Investigative Site Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Novartis Investigative Site Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Novartis Investigative Site Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Novartis Investigative Site Recruiting
London, Ontario, Canada, N6A 4L6
Novartis Investigative Site Recruiting
Newmarket, Ontario, Canada, J7Y 2P9
Novartis Investigative Site Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Novartis Investigative Site Recruiting
Sault Ste Marie, Ontario, Canada, P6B 0A8
Novartis Investigative Site Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site Recruiting
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Novartis Investigative Site Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H2W 1T8
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3T 1E2
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Novartis Investigative Site Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Novartis Investigative Site Recruiting
St-Jerome, Quebec, Canada, J7Z 5T3
Canada
Novartis Investigative Site Recruiting
Quebec, Canada, G1S 4L8
China, Jilin
Novartis Investigative Site Recruiting
Chang Chun, Jilin, China, 130021
China, Zhejiang
Novartis Investigative Site Recruiting
Hangzhou, Zhejiang, China, 310016
France
Novartis Investigative Site Recruiting
Nice Cedex 2, Alpes Maritimes, France, 06189
Novartis Investigative Site Recruiting
Dijon Cedex, Cote D Or, France, 21034
Novartis Investigative Site Recruiting
Limoges cedex, Haute Vienne, France, 87000
Novartis Investigative Site Recruiting
Saint-Cloud, Hauts De Seine, France, 92210
Novartis Investigative Site Recruiting
Rennes Cedex, Ille Et Vilaine, France, 35062
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Amiens, France, 80000
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Angers Cedex 02, France, 49055
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Argenteuil, France, 95107
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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, 33076
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Caen Cedex, France, 14021
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Grenoble cedex, France, 38028
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Le Mans, France, 72000
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Lyon, France, 69317
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Lyon, France, 69677
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Marseille, France, 13008
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Montpellier Cedex 5, France, 34298
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Montpellier, France, 34070
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Nantes cedex 2, France, 44202
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Paris Cedex 13, France, 75651
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Paris, France, 75010
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Paris, France, 75015
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Paris, France, 75231
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Paris, France, 75970
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Pierre Benite Cedex, France, 69495
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Rouen Cedex 1, France, 76038
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Saint Herblain cedex, France, 44805
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Strasbourg, France, F 67085
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Toulouse Cedex 9, France, 31059
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Vandoeuvre-les-Nancy cedex, France, 54519
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Villejuif Cedex, France, 94800
Germany
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Ravensburg, Baden-Wuerttemberg, Germany, 88212
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Muenchen, Bavaria, Germany, 80637
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Georgsmarienhuette, Lower Saxony, Germany, 49124
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Hannover, Niedersachsen, Germany, 30177
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Duesseldorf, Nordrhein Westfalen, Germany, 40325
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Essen, Nordrhein-Westfalen, Germany, 45136
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Velbert, North Rhine-westphalia, Germany, 42551
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Augsburg, Germany, 86150
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Augsburg, Germany, 86179
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Bad Liebenwerda, Germany, 04924
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Berlin, Germany, 13125
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Bonn, Germany, 53111
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Bottrop, Germany, 46236
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Cottbus, Germany, 03048
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Dresden, Germany, 01307
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Erlangen, Germany, 91054
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Essen, Germany, 45147
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Esslingen, Germany, 73730
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Frankfurt, Germany, 60431
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Halle S, Germany, 06120
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Hamburg, Germany, 20246
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Hamburg, Germany, 20357
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Kiel, Germany, 24105
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Lüneburg, Germany, 21339
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Mainz, Germany, 55131
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Mannheim, Germany, 68167
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Moenchengladbach, Germany, 41061
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Muenchen, Germany, 81377
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Muenster, Germany, 48149
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Munchen, Germany, 81675
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Regensburg, Germany, 93053
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Rostock, Germany, 18059
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Schweinfurt, Germany, 97422
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Tübingen, Germany, 72076
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Ulm, Germany, 89081
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Wuerzburg, Germany, 97080
Hungary
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Zalaegerszeg, Zala, Hungary, 8900
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Budapest, Hungary, 1085
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Budapest, Hungary, 1145
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Budapest, Hungary, H-1032
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Debrecen, Hungary, 4032
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Kecskemet, Hungary, 6000
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Pecs, Hungary, 7624
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Szeged, Hungary, 6725
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Szekszard, Hungary, 7100
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Szombathely, Hungary, 9700
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Tatabanya, Hungary, H 2800
Ireland
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Wilton, Cork, Ireland
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Dublin 9, D9, Ireland
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County Limerick, Ireland, V94 F858
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Dublin 4, Ireland
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Dublin 7, Ireland
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Dublin, Ireland, 8
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Waterford, Ireland
Italy
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Torrette AN, Ancona, Italy, 60126
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Bergamo, BG, Italy, 24127
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Brindisi, BR, Italy, 72100
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Catania, CT, Italy, 95045
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Milano, MI, Italy, 20133
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Rozzano, MI, Italy, 20089
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Palermo, PA, Italy, 90146
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Aviano, PN, Italy, 33081
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Roma, RM, Italy, 00128
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Candiolo, TO, Italy, 10060
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Bologna, Italy, 40138
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Napoli, Italy, 80131
Korea, Republic of
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Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
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Seoul, Daegu, Korea, Republic of, 41404
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Wonju-si, Gangwon-do, Korea, Republic of, 26426
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Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
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Gyeonggi do, Korea, Korea, Republic of, 10408
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Seoul, Korea, Korea, Republic of, 03722
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Suwon, Kyonggi Do, Korea, Republic of, 16499
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Seoul, Seocho Gu, Korea, Republic of, 06591
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Incheon, Korea, Republic of, 22332
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Incheon, Korea, Republic of, 405 760
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Seongnam Si Gyeonggi Do, Korea, Republic of, 463-712
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Seoul, Korea, Republic of, 02841
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 158-710
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Ulsan, Korea, Republic of, 44033
Poland
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Warsaw, Ul Roentgena 5, Poland, 02 781
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Bialystok, Poland, 15 027
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Gdynia, Poland, 81 519
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Gliwice, Poland, 44 101
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Grudziadz, Poland, 86 300
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Krakow, Poland, 31 501
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Lodz, Poland, 90 242
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Lublin, Poland, 20 090
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Opole, Poland, 45 054
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Ostroleka, Poland, 07 410
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Otwock, Poland, 05 400
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Wieliszew, Poland, 05 135
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Wroclaw, Poland, 53 413
Romania
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Craiova, Dolj, Romania, 200347
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Craiova, Dolj, Romania, 200535
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Bucuresti, Romania, 010991
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Bucuresti, Romania, 011171
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Cluj-Napoca, Romania, 400124
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Iasi, Romania, 700106
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Timisoara, Romania, 300239
Russian Federation
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Leningrad Region, Russia, Russian Federation, 188663
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St Petersburg, Saint Petersburg, Russian Federation, 195271
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Chelyabinsk, Russian Federation, 454087
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Kazan, Russian Federation, 420029
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Kostroma, Russian Federation, 156005
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Krasnoyarsk, Russian Federation, 660022
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 111123
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 143423
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Nizhny Novgorod, Russian Federation, 603137
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Novosibirsk, Russian Federation
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Obninsk, Russian Federation, 249036
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Omsk, Russian Federation, 644013
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Orenburg, Russian Federation, 460021
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Rostov-na-Donu, Russian Federation, 344037
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Ryazan, Russian Federation, 390011
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St Petersburg, Russian Federation, 197758
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St- Petersburg, Russian Federation, 197022
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Tyumen, Russian Federation, 625041
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Ufa, Russian Federation, 450054
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Yaroslavl, Russian Federation, 150054
Spain
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Elche, Alicante, Spain, 03203
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Cordoba, Andalucia, Spain, 14004
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Granada, Andalucia, Spain, 18014
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Huelva, Andalucia, Spain, 21005
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Jaen, Andalucia, Spain, 23007
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Malaga, Andalucia, Spain, 29010
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Sevilla, Andalucia, Spain, 41013
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Sevilla, Andalucia, Spain, 41017
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Avila, Castilla Y Leon, Spain, 05004
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Burgos, Castilla Y Leon, Spain, 09006
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Salamanca, Castilla Y Leon, Spain, 37007
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Badalona, Cataluna, Spain, 08916
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Barcelona, Catalunya, Spain, 08036
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Manresa, Catalunya, Spain, 08240
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Barcelona, Cataluña, Spain, 08907
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Alicante, Comunidad Valenciana, Spain, 03550
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Valencia, Comunidad Valenciana, Spain, 46010
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Valencia, Comunidad Valenciana, Spain, 46014
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Badajoz, Extremadura, Spain, 06080
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Caceres, Extremadura, Spain, 10003
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A Coruna, Galicia, Spain, 15009
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La Coruna, Galicia, Spain, 15006
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Lugo, Galicia, Spain, 27003
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Fuenlabrada, Madrid, Spain, 28942
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El Palmar, Murcia, Spain, 30120
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Madrid, N Ap, Spain, 28034
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San Sebastian, Pais Vasco, Spain, 20080
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Vitoria-Gasteiz, País Vasco, Spain, 01009
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Vigo, Pontevedra, Spain, 36312
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La Laguna, Santa Cruz De Tenerife, Spain, 38320
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Barcelona, Spain, 08035
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Bilbao, Spain, 48013
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Castellon, Spain, 12002
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Girona, Spain, 17007
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Granada, Spain, 18013
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Madrid, Spain, 28009
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Madrid, Spain, 28033
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Madrid, Spain, 28040
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Madrid, Spain, 28222
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Murcia, Spain, 30008
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Navarra, Spain, 31008
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Sabadell, Spain, 08208
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Valencia, Spain, 46009
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Zaragoza, Spain, 50009
Taiwan
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Changhua, Taiwan, 50006
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Taichung, Taiwan, 40447
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Taichung, Taiwan, 407
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 10449
Novartis Investigative Site Recruiting
Taipei, Taiwan, 11217
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Taipei, Taiwan
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Taoyuan, Taiwan, 33305
United Kingdom
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Truro, Cornwall, United Kingdom, TR1 3LJ
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Maidstone, Kent, United Kingdom, M16 9QQ
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Cardiff, United Kingdom, CF14 2TL
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London, United Kingdom, NW1 2BU
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London, United Kingdom, SE1 9RT
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London, United Kingdom, SM2 5PT
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London, United Kingdom, SW3 6JJ
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Nottingham, United Kingdom, NG5 1PB
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Oxford, United Kingdom, OX3 7LJ
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Preston, United Kingdom, PR2 9HT
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Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Novartis Pharmaceuticals
Translational Research in Oncology
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03701334    
Other Study ID Numbers: CLEE011O12301C
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
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 review 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 availability is according to the criteria and process described on 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 ):
early breast cancer (EBC)
HR+/HER2-
adjuvant
LEE011
ribociclib
CDK4/6 inhibitor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases