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 : February 26, 2021
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Early Breast Cancer | Drug: Ribociclib Other: Endocrine Therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5000 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 |

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) |
- 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
- Recurrence-free survival [ Time Frame: 44 months ]using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)
- Distant disease-free survival [ Time Frame: 44 months ]using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)
- Overall Survival [ Time Frame: 91 months ]overall survival
- 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.
- 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.
- 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)

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

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


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, South Carolina | |
Tidelands Health Oncology | Recruiting |
Murrells Inlet, South Carolina, United States, 29576 | |
Principal Investigator: Sara Adams | |
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 | |
Novartis Investigative Site | Recruiting |
Heidelberg, Victoria, Australia, 3084 | |
Novartis Investigative Site | Recruiting |
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 | |
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Windsor, Ontario, Canada, N8W 2X3 | |
Canada, Quebec | |
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Greenfield Park, Quebec, Canada, J4V 2H1 | |
Novartis Investigative Site | Withdrawn |
Montreal, Quebec, Canada, H1T 2M4 | |
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Montreal, Quebec, Canada, H2W 1T8 | |
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Montreal, Quebec, Canada, H3T 1E2 | |
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Montreal, Quebec, Canada, H4A 3J1 | |
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Sherbrooke, Quebec, Canada, J1H 5N4 | |
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St-Jerome, Quebec, Canada, J7Z 5T3 | |
Canada | |
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Quebec, Canada, G1S 4L8 | |
China, Heilongjiang | |
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Harbin, Heilongjiang, China, 150081 | |
China, Jiangsu | |
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Suzhou, Jiangsu, China, 215004 | |
China, Jilin | |
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Chang Chun, Jilin, China, 130021 | |
China, Sichuan | |
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Chengdu, Sichuan, China, 610041 | |
China, Zhejiang | |
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Hangzhou, Zhejiang, China, 310016 | |
China | |
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Zhenjiang, China | |
France | |
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Nice Cedex 2, Alpes Maritimes, France, 06189 | |
Novartis Investigative Site | Recruiting |
Dijon Cedex, Cote D Or, France, 21034 | |
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Limoges cedex, Haute Vienne, France, 87000 | |
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Saint-Cloud, Hauts De Seine, France, 92210 | |
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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, 7623 | |
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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 | |
Novartis Investigative Site | Recruiting |
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 | |
Novartis Investigative Site | Recruiting |
Seoul, Daegu, Korea, Republic of, 41404 | |
Novartis Investigative Site | Recruiting |
Wonju-si, Gangwon-do, Korea, Republic of, 26426 | |
Novartis Investigative Site | Recruiting |
Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620 | |
Novartis Investigative Site | Recruiting |
Gyeonggi do, Korea, Korea, Republic of, 10408 | |
Novartis Investigative Site | Recruiting |
Seoul, Korea, Korea, Republic of, 03722 | |
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Suwon, Kyonggi Do, Korea, Republic of, 16499 | |
Novartis Investigative Site | Recruiting |
Seoul, Seocho Gu, Korea, Republic of, 06591 | |
Novartis Investigative Site | Recruiting |
Incheon, Korea, Republic of, 22332 | |
Novartis Investigative Site | Recruiting |
Incheon, Korea, Republic of, 405 760 | |
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Seongnam Si Gyeonggi Do, Korea, Republic of, 463-712 | |
Novartis Investigative Site | Recruiting |
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 | |
Novartis Investigative Site | Recruiting |
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 | |
Novartis Investigative Site | Withdrawn |
Kursk, Russian Federation, 305035 | |
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Moscow, Russian Federation, 111123 | |
Novartis Investigative Site | Recruiting |
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 | |
Novartis Investigative Site | Recruiting |
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 | |
Novartis Investigative Site | Recruiting |
Tainan, Taiwan, 70403 | |
Novartis Investigative Site | Recruiting |
Taipei, Taiwan, 10002 | |
Novartis Investigative Site | Recruiting |
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 | |
Novartis Investigative Site | Recruiting |
London, United Kingdom, NW1 2BU | |
Novartis Investigative Site | Recruiting |
London, United Kingdom, SE1 9RT | |
Novartis Investigative Site | Recruiting |
London, United Kingdom, SM2 5PT | |
Novartis Investigative Site | Recruiting |
London, United Kingdom, SW3 6JJ | |
Novartis Investigative Site | Recruiting |
Nottingham, United Kingdom, NG5 1PB | |
Novartis Investigative Site | Recruiting |
Oxford, United Kingdom, OX3 7LJ | |
Novartis Investigative Site | Recruiting |
Preston, United Kingdom, PR2 9HT | |
Novartis Investigative Site | Recruiting |
Stoke-on-Trent, United Kingdom, ST4 6QG |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03701334 |
Other Study ID Numbers: |
CLEE011O12301C |
First Posted: | October 10, 2018 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
early breast cancer (EBC) HR+/HER2- adjuvant |
LEE011 ribociclib CDK4/6 inhibitor |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |