A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
NATALEE
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)
3 other identifiers
interventional
5,101
19 countries
363
Brief Summary
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2018
Longer than P75 for phase_3
363 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2018
CompletedFirst Posted
Study publicly available on registry
October 10, 2018
CompletedStudy Start
First participant enrolled
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 29, 2030
April 1, 2026
March 1, 2026
11.5 years
September 21, 2018
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Invasive Disease-Free Survival (iDFS)
Invasive Disease-Free Survival (iDFS) is defined as the time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed locally using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
Up to approximately 139 months
Secondary Outcomes (6)
Recurrence-free survival (RFS)
Up to approximately 139 months
Distant disease-free survival (DDFS)
Up to approximately 139 months
Overall Survival (OS)
Up to approximately 139 months
Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30
Up to approximately 139 months
Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30
Up to approximately 139 months
- +1 more secondary outcomes
Study Arms (2)
Ribociclib + Endocrine Therapy (ET)
EXPERIMENTALEligible participants will receive Ribociclib 400 mg once daily on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28). And Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks.
Endocrine Therapy (ET)
ACTIVE COMPARATOREligible participants will receive Endocrine Therapy (ET) consisting of: * For postmenopausal women: \- Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. * For premenopausal women and men: * Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with: * Goserelin 3.6 mg subcutaneously once every 4 weeks.
Interventions
Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle
Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information
Eligibility Criteria
You may qualify if:
- Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.
- 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.
- Postmenopausal status is defined as:
- Patient underwent bilateral oophorectomy, or
- Age ≥ 60 years, or
- Age \< 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.
- If taking tamoxifen or toremifene and age \<60 years, then FSH and plasma estradiol level in postmenopausal ranges.
- Notes
- In women who are premenopausal at the beginning of adjuvant chemotherapy, amenorrhea is not a reliable indicator of menopausal status as ovarian function may still be intact or resume despite anovulation/amenorrhea. For these women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status.
- All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.
- Patient has breast cancer that is positive for ER and/or PgR according to the local laboratory as determined on the most recently analyzed tissue sample.
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory).
- Patient (except those enrolled in China) has available archival tumor tissue from the surgical specimen, for submission to a central laboratory (Note: in patients that underwent neoadjuvant systemic therapy and had a pathologic complete response, archival tumor tissue at the time of the initial diagnosis or before the administration of neoadjuvant therapy is mandatory).
- 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:
- +44 more criteria
You may not qualify if:
- 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 (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy).
- 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 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 to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03 Grade ≤1 at day of randomization. Exceptions to this criterion: patients with any grade of alopecia, amenorrhea, grade 2 neuropathy are allowed to enter the trial or other toxicities not considered a safety risk for the patient as per Investigator's discretion, are allowed to enter the trial.
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible.
- Patient has known history of human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local regulation).
- Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (testing is not mandatory, unless required by local regulation).
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
- History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.
- Documented cardiomyopathy.
- Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- Translational Research in Oncologycollaborator
Study Sites (387)
University of Alabama at Birmingham-Kirklin Clinic
Birmingham, Alabama, 35294-0006, United States
Cancer Treatment Centers of America
Goodyear, Arizona, 85338, United States
St Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
Comprehensive Blood and Cancer
Bakersfield, California, 93309, United States
UCLA Beverly Hills
Beverly Hills, California, 90212, United States
UCLA Burbank
Burbank, California, 91505, United States
Encino Research Center
Encino, California, 91436, United States
St. Jude Heritage Medical Group
Fullerton, California, 92835, United States
UCLA Hematology Oncology
Laguna Hills, California, 92653, United States
Southern CA Oncology Rsrch Alliance
Los Angeles, California, 90057, United States
Stanford University Medical Center
Palo Alto, California, 94304-1509, United States
UCLA Pasadena HC Hemato Onco
Pasadena, California, 941105, United States
UCLA Porter Ranch Hemato and Onco
Porter Ranch, California, 91326, United States
Cancer Care Associates Medical Grp
Redondo Beach, California, 90277, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
UCSF
San Francisco, California, 94115, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
UCLA Santa Monica Hematology Oncology
Santa Monica, California, 90404, United States
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910, United States
UCLA Valencia
Valencia, California, 91355, United States
Valley Breast Care
Van Nuys, California, 91405, United States
UCLA Cancer Center Westlake Village
Westlake Village, California, 91361, United States
University Of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Hospital of Central Connecticut
New Britain, Connecticut, 06052, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Holy Cross Hospital-Ft. Lauderdale
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Health Clinical Trials
Orlando, Florida, 32806, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists Pan
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
Cancer Treatment Centers of America
Zion, Illinois, 60099, United States
Cancer Care Center
New Albany, Indiana, 47150, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Cancer Center of Kansas
Wichita, Kansas, 67214-3728, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
Fairview Health Services
Maple Grove, Minnesota, 55369, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 64111, United States
HCA Midwest Division
Kansas City, Missouri, 64132, United States
David C Pratt Cancer Center
St Louis, Missouri, 63141, United States
St Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Saint Francis Medical Center
Grand Island, Nebraska, 68803, United States
Comprehensive Cancer Cntr Of Nevada
Henderson, Nevada, 89052, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Perlmutter Cancer Centre
New York, New York, 10016, United States
Randolph Medical Associates
Asheboro, North Carolina, 27204, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Kaiser Permanente NW Region
Clackamas, Oregon, 97015, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
Cancer Treatment Centers of America Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
The West Clinic
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Baylor Charles A Sammons Cancer Cnt
Dallas, Texas, 75246, United States
Ctr For Cancer And Blood Disorders
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center University of Texas
Houston, Texas, 77030, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Wisconsin Paul P Carbone Comp Cancer Center
Madison, Wisconsin, 53792 6164, United States
Novartis Investigative Site
San Salvador de Jujuy, Jujuy Province, 4600, Argentina
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Rosario, Santa Fe Province, S2000, Argentina
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Rosario, Sante Fe, S200KZE, Argentina
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San Miguel Tucuman, Tucumán Province, T4000IAK, Argentina
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Rio Negro, Viedma, 8500, Argentina
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CABA, C1419AHN, Argentina
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Córdoba, X5004FHP, Argentina
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La Rioja, 5300, Argentina
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Campbelltown, New South Wales, 2560, Australia
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Coffs Harbour, New South Wales, 2450, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Kingswood, New South Wales, 2747, Australia
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Kogarah, New South Wales, 2217, Australia
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North Ryde, New South Wales, 2109, Australia
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St Leonards, New South Wales, 2065, Australia
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Wahroonga, New South Wales, 2076, Australia
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Westmead, New South Wales, 2145, Australia
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Auchenflower, Queensland, 4066, Australia
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Birtinya, Queensland, 4575, Australia
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Wooloongabba, Queensland, 4102, Australia
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Bedford Park, South Australia, 5041, Australia
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Bendigo, Victoria, 3550, Australia
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East Melbourne, Victoria, 3002, Australia
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Epping, Victoria, 3076, Australia
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Fitzroy, Victoria, 3065, Australia
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Franston, Victoria, 3199, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3000, Australia
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Shepparton, Victoria, 3630, Australia
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Murdoch, Western Australia, 6150, Australia
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Nedlands, Western Australia, 6009, Australia
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Liverpool, 2170, Australia
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Innsbruck, Tyrol, 6020, Austria
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Graz, 8036, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Hasselt, Limburg, 3500, Belgium
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Leuven, Vlaams Brabant, 3000, Belgium
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Brussels, 1000, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Jette, 1090, Belgium
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Libramont, 6800, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Wilrijk, 2610, Belgium
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Yvoir, 5530, Belgium
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Londrina, Paraná, 86015-520, Brazil
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Ijuí, Rio Grande do Sul, 98700-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
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Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
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Barretos, São Paulo, 14784 400, Brazil
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Santo André, São Paulo, 09060-650, Brazil
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São Paulo, São Paulo, 01317 000, Brazil
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São Paulo, São Paulo, 04014-002, Brazil
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Caxias do Sul, 95070-560, Brazil
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Passo Fundo, 99010-080, Brazil
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Piracicaba, 13419-155, Brazil
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Recife, 50040-000, Brazil
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Rio de Janeiro, 20560-120, Brazil
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Salvador, 41810 570, Brazil
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São Paulo, 01255-000, Brazil
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Calgary, Alberta, T2N4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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North Vancouver, British Columbia, V7L 2L7, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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London, Ontario, N6A 5W9, Canada
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Newmarket, Ontario, J7Y 2P9, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Sault Ste. Marie, Ontario, P6B 0A8, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Windsor, Ontario, N8W 2X3, Canada
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Fleurimont, Quebec, J1H 5N4, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Guangzhou, Guangdong, 510000, China
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Shijiazhuang, Hebei, 050011, China
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Harbin, Heilongjiang, 150081, China
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Zhengzhou, Henan, 450008, China
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Wuhan, Hubei, 430022, China
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Nanjing, Jiangsu, 210029, China
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Suzhou, Jiangsu, 215004, China
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Changchun, Jilin, 130021, China
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Chengdu, Sichuan, 610041, China
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Hangzhou, Zhejiang, 310016, China
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Beijing, 100021, China
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Chongqing, 400016, China
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Shanghai, 200032, China
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Tianjin, 300480, China
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Zhenjiang, 310009, China
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Nice, Alpes Maritimes, 06189, France
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Dijon, Cote D Or, 21034, France
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Limoges, Haute Vienne, 87000, France
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Saint-Cloud, Hauts De Seine, 92210, France
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Rennes, Ille Et Vilaine, 35062, France
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Grenoble, Isere, 38028, France
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Lyon, Rhone, 69004, France
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Amiens, 80000, France
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Angers, 49055, France
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Argenteuil, 95107, France
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Avignon, 84082, France
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Besançon, 25030, France
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Bordeaux, 33076, France
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Bron, 69677, France
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Caen, 14021, France
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Le Mans, 72000, France
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Marseille, 13008, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Nantes, 44202, France
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Paris, 75013, France
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Paris, 75015, France
Novartis Investigative Site
Paris, 75231, France
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Paris, 75475, France
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Paris, 75970, France
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Pierre-Bénite, 69495, France
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Rouen, 76038, France
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Saint-Herblain, 44805, France
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Strasbourg, F 67085, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54519, France
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Villejuif, 94800, France
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Ravensburg, Baden-Wurttemberg, 88212, Germany
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Munich, Bavaria, 80637, Germany
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Munich, Bavaria, 81377, Germany
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Munich, Bavaria, 81675, Germany
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Würzburg, Bavaria, 97080, Germany
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Cottbus, Brandenburg, 03048, Germany
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Frankfurt am Main, Hesse, 60431, Germany
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Georgsmarienhütte, Lower Saxony, 49124, Germany
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Hanover, Lower Saxony, 30177, Germany
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Essen, North Rhine-Westphalia, 45136, Germany
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Mönchengladbach, North Rhine-Westphalia, 41061, Germany
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Velbert, North Rhine-Westphalia, 42551, Germany
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Dresden, Saxony, 01307, Germany
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Augsburg, 86150, Germany
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Bad Liebenwerda, 04924, Germany
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Berlin, 13125, Germany
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Bonn, 53111, Germany
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Bottrop, 46236, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Hamburg, 20357, Germany
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Kiel, 24105, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Münster, 48149, Germany
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Regensburg, 93053, Germany
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Schweinfurt, 97422, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Pécs, Baranya, 7623, Hungary
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Debrecen, Hajdu Bihar Megye, 4032, Hungary
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Zalaegerszeg, Zala County, 8900, Hungary
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Budapest, H-1032, Hungary
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Budapest, H-1083, Hungary
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Budapest, H-1145, Hungary
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Kecskemét, 6001, Hungary
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Szeged, 6725, Hungary
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Szekszárd, 7100, Hungary
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Szombathely, H-9700, Hungary
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Tatabánya, H 2800, Hungary
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Wilton, Cork, T12 DC4A, Ireland
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County Limerick, V94 F858, Ireland
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Dublin, 533615, Ireland
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Dublin, D03 VX82, Ireland
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Dublin, DO4, Ireland
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Dublin, DUBLIN 9, Ireland
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Waterford, 48346, Ireland
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Ancona, AN, 60126, Italy
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Bergamo, BG, 24127, Italy
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Bologna, BO, 40138, Italy
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Catania, CT, 95123, Italy
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Milan, MI, 20133, Italy
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Rozzano, MI, 20089, Italy
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Palermo, PA, 90146, Italy
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Aviano, PN, 33081, Italy
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Roma, RM, 00128, Italy
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Candiolo, TO, 10060, Italy
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Naples, 80131, Italy
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Warsaw, Ul Roentgena 5, 02 781, Poland
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Bialystok, 15-027, Poland
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Gdynia, 81 519, Poland
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Gliwice, 44 101, Poland
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Grudziądz, 86 300, Poland
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Krakow, 31501, Poland
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Lodz, 90-338, Poland
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Lublin, 20 090, Poland
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Opole, 45 054, Poland
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Ostrołęka, 07-410, Poland
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Otwock, 05 400, Poland
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Wieliszew, 05-135, Poland
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Wroclaw, 02-781, Poland
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Cluj-Napoca, Cluj, 400015, Romania
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Craiova, Dolj, 200347, Romania
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Craiova, Dolj, 200535, Romania
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Bucharest, 011171, Romania
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Timișoara, 300425, Romania
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Kazan', Russian Federation, 420029, Russia
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Related Publications (3)
Fasching PA, Stroyakovskiy D, Yardley DA, Huang CS, Crown J, Bardia A, Chia S, Im SA, Martin M, Xu B, Loi S, Barrios C, Untch M, Moroose R, Visco F, Hortobagyi GN, Slamon DJ, Fresco R, Zarate JP, Li Z, Waters S, Hurvitz SA. Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1364-1372. doi: 10.1001/jamaoncol.2025.3700.
PMID: 40996773DERIVEDSlamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching PA, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091. doi: 10.1056/NEJMoa2305488.
PMID: 38507751DERIVEDSlamon DJ, Fasching PA, Hurvitz S, Chia S, Crown J, Martin M, Barrios CH, Bardia A, Im SA, Yardley DA, Untch M, Huang CS, Stroyakovskiy D, Xu B, Moroose RL, Loi S, Visco F, Bee-Munteanu V, Afenjar K, Fresco R, Taran T, Chakravartty A, Zarate JP, Lteif A, Hortobagyi GN. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol. 2023 May 29;15:17588359231178125. doi: 10.1177/17588359231178125. eCollection 2023.
PMID: 37275963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 21, 2018
First Posted
October 10, 2018
Study Start
December 7, 2018
Primary Completion (Estimated)
May 29, 2030
Study Completion (Estimated)
May 29, 2030
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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