Clinical Trial - NCT03701334

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Recruiting

Sponsor: Novartis Pharmaceuticals

Collaborators: Translational Research in Oncology

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03701334

Protocol Info

Short Description: Ribociclib + Endocrine Therapy In Breast Cancer
Long Description: A Phase III, Multicenter, 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 (NATALEE)
MGH Status: Open
Sponsor: Novartis
Disease Program: Breast

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Early Breast Cancer Ribociclib Endocrine Therapy Phase 3
Study Type Interventional
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-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Primary Outcome Measures

Invasive Disease-Free Survival [Time Frame: 3.5 years] [Designated as safety issue: ]


Secondary Outcome Measures

Recurrence-free survival [Time Frame: 3.5 years] [Designated as safety issue: ]

Distant disease-free survival [Time Frame: 3.5 years] [Designated as safety issue: ]

Overall Survival [Time Frame: 7.5 years] [Designated as safety issue: ]

Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30 [Time Frame: 3.5 years] [Designated as safety issue: ]

Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30 [Time Frame: 3.5 years] [Designated as safety issue: ]

PK parameter Ctrough and other applicable parameters for ribociclib [Time Frame: 3.5 years] [Designated as safety issue: ]

Estimated Enrollment: 4000
Study Start Date: December 2018
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025
Arms Assigned Interventions

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

Active Comparator:Endocrine Therapy

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

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03701334

Locations

  • United States, Alabama
    • University of Alabama at Birmingham/ Kirklin Clinic Birmingham, Alabama, United States, 35294-0006
  • United States, Arizona
    • Cancer Treatment Centers of America Goodyear, Arizona, United States, 85338
  • United States, Arkansas
    • St Bernards Medical Center Jonesboro, Arkansas, United States, 72401
  • United States, California
    • Comprehensive Blood and Cancer Center SC-2 Bakersfield, California, United States, 93309
    • UCLA Beverly Hills Beverly Hills, California, United States, 90212
    • UCLA Burbank Burbank, California, United States, 91505
    • Encino Research Center Encino, California, United States, 91436
    • UCLA Hematology Oncology Laguna Hills, California, United States, 92653
    • Southern California Oncology Research Alliance SCORA Los Angeles, California, United States, 90057
    • UCLA Central Regulatory Los Angeles, California, United States, 90095
    • Valley Breast Care and Women s Health Center Los Angeles, California, United States, 91405
    • Stanford University Medical Center Palo Alto, California, United States, 94304-1509
    • UCLA Pasadena Health Care Hematology Oncology Pasadena, California, United States, 941105
    • UCLA Porter Ranch Hematology and Oncology Porter Ranch, California, United States, 91326
    • Cancer Care Associates Medical Group Redondo Beach, California, United States, 90277
    • Sharp Memorial Hospital Regulatory San Diego, California, United States, 92123
    • University of California San Francisco Gynecologic Oncology San Francisco, California, United States, 94115
    • Central Coast Medical Oncology Corporation Onc Dept Santa Maria, California, United States, 93454
    • UCLA Santa Monica Hematology / Oncology Regulatory-2 Santa Monica, California, United States, 90404
    • Lundquist Inst BioMed at Harbor Torrance, California, United States, 90509-2910
    • Gene Upshaw Memorial Tahoe Forest Cancer Cntr Truckee, California, United States, 96161
    • UCLA Valencia Valencia, California, United States, 91355
    • Wellness Oncology Hematology TRM West Hills, California, United States, 91307
    • UCLA Cancer Center, Westlake Village Westlake Village, California, United States, 91361
    • St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr Yorba Linda, California, United States, 92886
  • United States, Colorado
    • University of Colorado Hospital Aurora, Colorado, United States, 80045
    • Rocky Mountain Cancer Centers Greenwood Village, Colorado, United States, 80303
  • United States, Connecticut
    • Hospital of Central Connecticut New Britain, Connecticut, United States, 06052
    • Yale University School of Medicine New Haven, Connecticut, United States, 06520
    • Norwalk Hospital Pulmonary Medicine Norwalk, Connecticut, United States, 06856
    • Eastern Connecticut Hematology and Oncology Associates Regulatory Norwich, Connecticut, United States, 06360
  • United States, Florida
    • Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01 Fort Lauderdale, Florida, United States, 33308
    • Florida Cancer Specialists Fort Myers, Florida, United States, 33901
    • Memorial Cancer Institute Hollywood, Florida, United States, 33021
    • University of Miami Miami, Florida, United States, 33136
    • Orlando Health, Clinical Trials Orlando Health Inc Orlando, Florida, United States, 32806
    • Florida Cancer Specialists - North Saint Petersburg, Florida, United States, 33705
    • Florida Cancer Specialists Panhandle Tallahassee, Florida, United States, 32308
    • Florida Cancer Specialists- East Region West Palm Beach, Florida, United States, 33401
  • United States, Georgia
    • Southeastern Regional Medical Center Newnan, Georgia, United States, 30265
  • United States, Illinois
    • Cancer Treatment Centers of America Zion, Illinois, United States, 60099
  • United States, Indiana
    • Fort Wayne Medical Oncology/Hematology, Inc. Fort Wayne, Indiana, United States, 46815
    • Cancer Care Center New Albany, Indiana, United States, 47150
  • United States, Kansas
    • University of Kansas Cancer Center Westwood, Kansas, United States, 66205
    • Cancer Center of Kansas Wichita, Kansas, United States, 67214-3728
  • United States, Maryland
    • Mercy Medical Center Baltimore, Maryland, United States, 21202
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • University of Michigan Cancer Center Ann Arbor, Michigan, United States, 48109
  • United States, Minnesota
    • Fairview Health Services Maple Grove, Minnesota, United States, 55369
    • Metro Minnesota CCOP Metro Minneapolis CCOP Saint Louis Park, Minnesota, United States, 55416
    • Park Nicollet Institute Saint Louis Park, Minnesota, United States, 55416
  • United States, Missouri
    • Saint Luke's Hospital of Kansas City Kansas City, Missouri, United States, 64111
    • HCA Midwest Division Kansas City, Missouri, United States, 64132
    • David C Pratt Cancer Center Saint Louis, Missouri, United States, 63141
  • United States, Montana
    • St Vincent Frontier Cancer Center Billings, Montana, United States, 59102
  • United States, Nebraska
    • Saint Francis Medical Center Grand Island, Nebraska, United States, 68803
  • United States, Nevada
    • Comprehensive Cancer Centers of Nevada Las Vegas, Nevada, United States, 89109
  • United States, New Jersey
    • Saint Barnabas Medical Center Livingston, New Jersey, United States, 07039
  • United States, New York
    • Perlmutter Cancer Centre New York, New York, United States, 10016
  • United States, North Carolina
    • Randolph Medical Associates Asheboro, North Carolina, United States, 27204
    • Alamance Regional Medical Cancer Center Burlington, North Carolina, United States, 27215
    • Cone Health Cancer Center Greensboro, North Carolina, United States, 27403
  • United States, Oregon
    • Kaiser Permanente NW Region Clackamas, Oregon, United States, 97015
  • United States, Pennsylvania
    • Penn State Hershey Cancer Institute Hershey, Pennsylvania, United States, 17033
    • Cancer Treatment Centers of America Eastern Regional Medical Center Philadelphia, Pennsylvania, United States, 19124
  • United States, Tennessee
    • The West Clinic Germantown, Tennessee, United States, 38138
    • Sarah Cannon Research Institute Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Baylor Charles A. Sammons Cancer Center Dallas, Texas, United States, 75246
    • Center for Cancer and Blood Disorders Research Department Fort Worth, Texas, United States, 76104
    • MD Anderson Cancer Center/University of Texas Houston, Texas, United States, 77030
  • United States, Utah
    • Utah Cancer Specialists Salt Lake City, Utah, United States, 84106
  • United States, Virginia
    • Virginia Cancer Specialists Fairfax, Virginia, United States, 22031
    • Virginia Cancer Institute Richmond, Virginia, United States, 23230
  • United States, Washington
    • Seattle Cancer Care Alliance Medical Oncology Seattle, Washington, United States, 98109
  • United States, Wisconsin
    • University of Wisconsin / Paul P. Carbone Comp Cancer Center Madison, Wisconsin, United States, 53792-6164
  • Argentina, Santa Fe
    • Novartis Investigative Site Rosario, Santa Fe, Argentina, S2000
  • Argentina, Sante Fe
    • Novartis Investigative Site Rosario, Sante Fe, Argentina, S200KZE
  • Argentina, Tucuman
    • Novartis Investigative Site San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
  • Argentina, Viedma
    • Novartis Investigative Site Rio Negro, Viedma, Argentina, 8500
  • Argentina,
    • Novartis Investigative Site Caba, , Argentina, C1419AHN
    • Novartis Investigative Site Jujuy, , Argentina, 4600
    • Novartis Investigative Site La Rioja, , Argentina, 5300
    • Novartis Investigative Site Santa Fe, , Argentina, 3000
  • Australia, New South Wales
    • Novartis Investigative Site Campbelltown, New South Wales, Australia, 2560
    • Novartis Investigative Site Coffs Harbour, New South Wales, Australia, 2450
    • Novartis Investigative Site Darlinghurst, New South Wales, Australia, 2010
    • Novartis Investigative Site Kingswood, New South Wales, Australia, 2747
    • Novartis Investigative Site Kogarah, New South Wales, Australia, 2217
    • Novartis Investigative Site Liverpool, New South Wales, Australia, 2170
    • Novartis Investigative Site North Ryde, New South Wales, Australia, 2109
    • Novartis Investigative Site St Leonards, New South Wales, Australia, 2065
    • Novartis Investigative Site Wahroonga, New South Wales, Australia, 2076
    • Novartis Investigative Site Westmead, New South Wales, Australia, 2145
  • Australia, Queensland
    • Novartis Investigative Site Auchenflower, Queensland, Australia, 4066
    • Novartis Investigative Site Birtinya, Queensland, Australia, 4575
    • Novartis Investigative Site Wooloongabba, Queensland, Australia, 4102
  • Australia, South Australia
    • Novartis Investigative Site Bedford Park, South Australia, Australia, 5042
  • Australia, Victoria
    • Novartis Investigative Site Bendigo, Victoria, Australia, 3550
    • Novartis Investigative Site East Melbourne, Victoria, Australia, 3002
    • Novartis Investigative Site Epping, Victoria, Australia, 3076
    • Novartis Investigative Site Fitzroy, Victoria, Australia, 3065
    • Novartis Investigative Site Franston, Victoria, Australia, 3199
    • Novartis Investigative Site Heidelberg, Victoria, Australia, 3084
    • Novartis Investigative Site Melbourne, Victoria, Australia, 3000
    • Novartis Investigative Site Shepparton, Victoria, Australia, 3630
  • Australia, Western Australia
    • Novartis Investigative Site Murdoch, Western Australia, Australia, 6150
    • Novartis Investigative Site Nedlands, Western Australia, Australia, 6009
  • Austria, Styria
    • Novartis Investigative Site Graz, Styria, Austria, 8036
  • Austria, Tyrol
    • Novartis Investigative Site Innsbruck, Tyrol, Austria, 6020
  • Austria,
    • Novartis Investigative Site Linz, , Austria, 4020
    • Novartis Investigative Site Salzburg, , Austria, 5020
    • Novartis Investigative Site Wien, , Austria, 1090
  • Belgium, Antwerpen
    • Novartis Investigative Site Edegem, Antwerpen, Belgium, 2650
  • Belgium,
    • Novartis Investigative Site Bruxelles, , Belgium, 1000
    • Novartis Investigative Site Bruxelles, , Belgium, 1090
    • Novartis Investigative Site Bruxelles, , Belgium, 1200
    • Novartis Investigative Site Charleroi, , Belgium, 6000
    • Novartis Investigative Site Hasselt, , Belgium, 3500
    • Novartis Investigative Site Leuven, , Belgium, 3000
    • Novartis Investigative Site Libramont, , Belgium, 6800
    • Novartis Investigative Site Liege, , Belgium, 4000
    • Novartis Investigative Site Namur, , Belgium, 5000
    • Novartis Investigative Site Wilrijk, , Belgium, 2610
    • Novartis Investigative Site Yvoir, , Belgium, 5530
  • Brazil, PR
    • Novartis Investigative Site Londrina, PR, Brazil, 86015-520
  • Brazil, Rio Grande Do Sul
    • Novartis Investigative Site Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
  • Brazil, RS
    • Novartis Investigative Site Porto Alegre, RS, Brazil, 90035-903
    • Novartis Investigative Site Porto Alegre, RS, Brazil, 90560-030
    • Novartis Investigative Site Porto Alegre, RS, Brazil, 90880-480
  • Brazil, Sao Paulo
    • Novartis Investigative Site Barretos, Sao Paulo, Brazil, 14784 400
  • Brazil, SP
    • Novartis Investigative Site Santo Andre, SP, Brazil, 09060-650
    • Novartis Investigative Site Sao Paulo, SP, Brazil, 01317 000
    • Novartis Investigative Site Sao Paulo, SP, Brazil, 03102-002
  • Brazil,
    • Novartis Investigative Site Caxias do Sul, , Brazil, 95070-560
    • Novartis Investigative Site Ijui, , Brazil, 98700-000
    • Novartis Investigative Site Passo Fundo, , Brazil, 99010-080
    • Novartis Investigative Site Piracicaba, , Brazil, 13419-155
    • Novartis Investigative Site Recife, , Brazil, 50040-000
    • Novartis Investigative Site Rio De Janeiro, , Brazil, 20560-120
    • Novartis Investigative Site Salvador, , Brazil, 41810 570
  • Canada, Alberta
    • Novartis Investigative Site Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, British Columbia
    • Novartis Investigative Site Kelowna, British Columbia, Canada, V1Y 5L3
    • Novartis Investigative Site North Vancouver, British Columbia, Canada, V7L 2L7
    • Novartis Investigative Site Surrey, British Columbia, Canada, V3V 1Z2
    • Novartis Investigative Site Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Nova Scotia
    • Novartis Investigative Site Halifax, Nova Scotia, Canada, B3H 1V7
  • Canada, Ontario
    • Novartis Investigative Site Kitchener, Ontario, Canada, N2G 1G3
    • Novartis Investigative Site London, Ontario, Canada, N6A 4L6
    • Novartis Investigative Site Newmarket, Ontario, Canada, J7Y 2P9
    • Novartis Investigative Site Oshawa, Ontario, Canada, L1G 2B9
    • Novartis Investigative Site Sault Ste Marie, Ontario, Canada, P6B 0A8
    • Novartis Investigative Site Sudbury, Ontario, Canada, P3E 5J1
    • Novartis Investigative Site Toronto, Ontario, Canada, M4N 3M5
    • Novartis Investigative Site Toronto, Ontario, Canada, M5G 2M9
    • Novartis Investigative Site Windsor, Ontario, Canada, N8W 2X3
  • Canada, Quebec
    • Novartis Investigative Site Greenfield Park, Quebec, Canada, J4V 2H1
    • Novartis Investigative Site Montreal, Quebec, Canada, H1T 2M4
    • Novartis Investigative Site Montreal, Quebec, Canada, H2W 1T8
    • Novartis Investigative Site Montreal, Quebec, Canada, H3T 1E2
    • Novartis Investigative Site Montreal, Quebec, Canada, H4A 3J1
    • Novartis Investigative Site Sherbrooke, Quebec, Canada, J1H 5N4
    • Novartis Investigative Site St-Jerome, Quebec, Canada, J7Z 5T3
  • Canada,
    • Novartis Investigative Site Quebec, , Canada, G1S 4L8
  • France, Alpes Maritimes
    • Novartis Investigative Site Nice Cedex 2, Alpes Maritimes, France, 06189
  • France, Cote D Or
    • Novartis Investigative Site Dijon Cedex, Cote D Or, France, 21034
  • France, Haute Vienne
    • Novartis Investigative Site Limoges cedex, Haute Vienne, France, 87000
  • France, Hauts De Seine
    • Novartis Investigative Site Saint-Cloud, Hauts De Seine, France, 92210
  • France, Ille Et Vilaine
    • Novartis Investigative Site Rennes Cedex, Ille Et Vilaine, France, 35062
  • France,
    • Novartis Investigative Site Amiens, , France, 80000
    • Novartis Investigative Site Angers Cedex 02, , France, 49055
    • Novartis Investigative Site Argenteuil, , France, 95107
    • Novartis Investigative Site Avignon Cedex, , France, 84082
    • Novartis Investigative Site Besancon cedex, , France, 25030
    • Novartis Investigative Site Bobigny Cedex, , France, 93009
    • Novartis Investigative Site Bordeaux Cedex, , France, 33076
    • Novartis Investigative Site Caen Cedex, , France, 14021
    • Novartis Investigative Site Grenoble cedex, , France, 38028
    • Novartis Investigative Site Le Mans, , France, 72000
    • Novartis Investigative Site Lyon, , France, 69317
    • Novartis Investigative Site Lyon, , France, 69677
    • Novartis Investigative Site Marseille, , France, 13008
    • Novartis Investigative Site Montpellier Cedex 5, , France, 34298
    • Novartis Investigative Site Montpellier, , France, 34070
    • Novartis Investigative Site Nantes cedex 2, , France, 44202
    • Novartis Investigative Site Paris Cedex 13, , France, 75651
    • Novartis Investigative Site Paris, , France, 75010
    • Novartis Investigative Site Paris, , France, 75015
    • Novartis Investigative Site Paris, , France, 75231
    • Novartis Investigative Site Paris, , France, 75970
    • Novartis Investigative Site Pierre Benite Cedex, , France, 69495
    • Novartis Investigative Site Rouen Cedex 1, , France, 76038
    • Novartis Investigative Site Saint Herblain cedex, , France, 44805
    • Novartis Investigative Site Strasbourg, , France, F 67085
    • Novartis Investigative Site Toulouse Cedex 9, , France, 31059
    • Novartis Investigative Site Vandoeuvre-les-Nancy cedex, , France, 54519
    • Novartis Investigative Site Villejuif Cedex, , France, 94805
  • Germany, Baden-Wuerttemberg
    • Novartis Investigative Site Ravensburg, Baden-Wuerttemberg, Germany, 88212
  • Germany, Bavaria
    • Novartis Investigative Site Muenchen, Bavaria, Germany, 80637
  • Germany, Lower Saxony
    • Novartis Investigative Site Georgsmarienhuette, Lower Saxony, Germany, 49124
  • Germany, Niedersachsen
    • Novartis Investigative Site Hannover, Niedersachsen, Germany, 30177
  • Germany, Nordrhein Westfalen
    • Novartis Investigative Site Duesseldorf, Nordrhein Westfalen, Germany, 40325
  • Germany, Nordrhein-Westfalen
    • Novartis Investigative Site Essen, Nordrhein-Westfalen, Germany, 45136
  • Germany, North Rhine-westphalia
    • Novartis Investigative Site Velbert, North Rhine-westphalia, Germany, 42551
  • Germany,
    • Novartis Investigative Site Augsburg, , Germany, 86150
    • Novartis Investigative Site Augsburg, , Germany, 86179
    • Novartis Investigative Site Bad Liebenwerda, , Germany, 04924
    • Novartis Investigative Site Berlin, , Germany, 13125
    • Novartis Investigative Site Bonn, , Germany, 53111
    • Novartis Investigative Site Bottrop, , Germany, 46236
    • Novartis Investigative Site Cottbus, , Germany, 03048
    • Novartis Investigative Site Dresden, , Germany, 01307
    • Novartis Investigative Site Erlangen, , Germany, 91054
    • Novartis Investigative Site Esslingen, , Germany, 73730
    • Novartis Investigative Site Frankfurt, , Germany, 60431
    • Novartis Investigative Site Halle S, , Germany, 06120
    • Novartis Investigative Site Hamburg, , Germany, 20357
    • Novartis Investigative Site Mannheim, , Germany, 68167
    • Novartis Investigative Site Muenchen, , Germany, 81377
    • Novartis Investigative Site Muenster, , Germany, 48149
    • Novartis Investigative Site Munchen, , Germany, 81675
    • Novartis Investigative Site Regensburg, , Germany, 93053
    • Novartis Investigative Site Rostock, , Germany, 18059
    • Novartis Investigative Site Schweinfurt, , Germany, 97422
    • Novartis Investigative Site Tübingen, , Germany, 72076
    • Novartis Investigative Site Ulm, , Germany, 89081
  • Hungary, Zala
    • Novartis Investigative Site Zalaegerszeg, Zala, Hungary, 8900
  • Hungary,
    • Novartis Investigative Site Budapest, , Hungary, 1145
    • Novartis Investigative Site Budapest, , Hungary, H-1032
    • Novartis Investigative Site Budapest, , Hungary, H-1082
    • Novartis Investigative Site Debrecen, , Hungary, 4032
    • Novartis Investigative Site Kecskemet, , Hungary, 6000
    • Novartis Investigative Site Pecs, , Hungary, 7624
    • Novartis Investigative Site Szeged, , Hungary, 6725
    • Novartis Investigative Site Szekszard, , Hungary, 7100
    • Novartis Investigative Site Szombathely, , Hungary, 9700
    • Novartis Investigative Site Tatabanya, , Hungary, H 2800
  • Ireland, Cork
    • Novartis Investigative Site Wilton, Cork, Ireland,
  • Ireland, D9
    • Novartis Investigative Site Dublin 9, D9, Ireland,
  • Ireland,
    • Novartis Investigative Site County Limerick, , Ireland, V94 F858
    • Novartis Investigative Site Dublin 4, , Ireland,
    • Novartis Investigative Site Dublin 7, , Ireland,
    • Novartis Investigative Site Dublin, , Ireland, 8
    • Novartis Investigative Site Waterford, , Ireland,
  • Italy, Ancona
    • Novartis Investigative Site Torrette AN, Ancona, Italy, 60126
  • Italy, BG
    • Novartis Investigative Site Bergamo, BG, Italy, 24127
  • Italy, BR
    • Novartis Investigative Site Brindisi, BR, Italy, 72100
  • Italy, MI
    • Novartis Investigative Site Milano, MI, Italy, 20133
    • Novartis Investigative Site Rozzano, MI, Italy, 20089
  • Italy, PA
    • Novartis Investigative Site Palermo, PA, Italy, 90146
  • Italy, PN
    • Novartis Investigative Site Aviano, PN, Italy, 33081
  • Italy, RM
    • Novartis Investigative Site Roma, RM, Italy, 00128
  • Italy,
    • Novartis Investigative Site Bologna, , Italy, 40138
    • Novartis Investigative Site Napoli, , Italy, 80131
  • Korea, Republic of, Chungcheongbuk Do
    • Novartis Investigative Site Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
  • Korea, Republic of, Daegu
    • Novartis Investigative Site Seoul, Daegu, Korea, Republic of, 41404
  • Korea, Republic of, Gangwon-do
    • Novartis Investigative Site Wonju-si, Gangwon-do, Korea, Republic of, 26426
  • Korea, Republic of, Gyeonggi Do
    • Novartis Investigative Site Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
  • Korea, Republic of, Korea
    • Novartis Investigative Site Gyeonggi do, Korea, Korea, Republic of, 10408
    • Novartis Investigative Site Seoul, Korea, Korea, Republic of, 03722
  • Korea, Republic of, Kyonggi Do
    • Novartis Investigative Site Suwon, Kyonggi Do, Korea, Republic of, 16499
  • Korea, Republic of, Seocho Gu
    • Novartis Investigative Site Seoul, Seocho Gu, Korea, Republic of, 06591
  • Korea, Republic of,
    • Novartis Investigative Site Incheon, , Korea, Republic of, 22332
    • Novartis Investigative Site Incheon, , Korea, Republic of, 405 760
    • Novartis Investigative Site Seongnam Si Gyeonggi Do, , Korea, Republic of, 463-712
    • Novartis Investigative Site Seoul, , Korea, Republic of, 02841
    • Novartis Investigative Site Seoul, , Korea, Republic of, 03080
    • Novartis Investigative Site Seoul, , Korea, Republic of, 05505
    • Novartis Investigative Site Seoul, , Korea, Republic of, 06351
    • Novartis Investigative Site Seoul, , Korea, Republic of, 158-710
    • Novartis Investigative Site Ulsan, , Korea, Republic of, 44033
  • Poland, Ul Roentgena 5
    • Novartis Investigative Site Warsaw, Ul Roentgena 5, Poland, 02 781
  • Poland,
    • Novartis Investigative Site Bialystok, , Poland, 15 027
    • Novartis Investigative Site Gdynia, , Poland, 81 519
    • Novartis Investigative Site Grudziadz, , Poland, 86 300
    • Novartis Investigative Site Krakow, , Poland, 31 501
    • Novartis Investigative Site Lodz, , Poland, 90 242
    • Novartis Investigative Site Lublin, , Poland, 20 090
    • Novartis Investigative Site Opole, , Poland, 45 054
    • Novartis Investigative Site Ostroleka, , Poland, 07 410
    • Novartis Investigative Site Otwock, , Poland, 05 400
    • Novartis Investigative Site Wieliszew, , Poland, 05 135
    • Novartis Investigative Site Wroclaw, , Poland, 53 413
  • Russian Federation, Russia
    • Novartis Investigative Site Leningrad Region, Russia, Russian Federation, 188663
  • Russian Federation, Saint Petersburg
    • Novartis Investigative Site St Petersburg, Saint Petersburg, Russian Federation, 195271
  • Russian Federation,
    • Novartis Investigative Site Chelyabinsk, , Russian Federation, 454087
    • Novartis Investigative Site Kazan, , Russian Federation, 420029
    • Novartis Investigative Site Kostroma, , Russian Federation, 156005
    • Novartis Investigative Site Krasnoyarsk, , Russian Federation, 660022
    • Novartis Investigative Site Kursk, , Russian Federation, 305035
    • Novartis Investigative Site Moscow, , Russian Federation, 111123
    • Novartis Investigative Site Moscow, , Russian Federation, 115478
    • Novartis Investigative Site Moscow, , Russian Federation, 143423
    • Novartis Investigative Site Nizhny Novgorod, , Russian Federation, 603137
    • Novartis Investigative Site Novosibirsk, , Russian Federation,
    • Novartis Investigative Site Obninsk, , Russian Federation, 249036
    • Novartis Investigative Site Omsk, , Russian Federation, 644013
    • Novartis Investigative Site Orenburg, , Russian Federation, 460021
    • Novartis Investigative Site Rostov-na-Donu, , Russian Federation, 344037
    • Novartis Investigative Site Ryazan, , Russian Federation, 390011
    • Novartis Investigative Site St Petersburg, , Russian Federation, 197758
    • Novartis Investigative Site St- Petersburg, , Russian Federation, 197022
    • Novartis Investigative Site Tyumen, , Russian Federation, 625041
    • Novartis Investigative Site Ufa, , Russian Federation, 450054
    • Novartis Investigative Site Yaroslavl, , Russian Federation, 150054
  • Spain, Alicante
    • Novartis Investigative Site Elche, Alicante, Spain, 03203
  • Spain, Andalucia
    • Novartis Investigative Site Cordoba, Andalucia, Spain, 14004
    • Novartis Investigative Site Granada, Andalucia, Spain, 18014
    • Novartis Investigative Site Huelva, Andalucia, Spain, 21005
    • Novartis Investigative Site Jaen, Andalucia, Spain, 23007
    • Novartis Investigative Site Malaga, Andalucia, Spain, 29010
    • Novartis Investigative Site Sevilla, Andalucia, Spain, 41013
    • Novartis Investigative Site Sevilla, Andalucia, Spain, 41017
  • Spain, Castilla Y Leon
    • Novartis Investigative Site Avila, Castilla Y Leon, Spain, 05004
    • Novartis Investigative Site Burgos, Castilla Y Leon, Spain, 09006
    • Novartis Investigative Site Salamanca, Castilla Y Leon, Spain, 37007
  • Spain, Cataluna
    • Novartis Investigative Site Badalona, Cataluna, Spain, 08916
  • Spain, Catalunya
    • Novartis Investigative Site Barcelona, Catalunya, Spain, 08036
    • Novartis Investigative Site Manresa, Catalunya, Spain, 08240
  • Spain, Cataluña
    • Novartis Investigative Site Barcelona, Cataluña, Spain, 08907
  • Spain, Comunidad Valenciana
    • Novartis Investigative Site Alicante, Comunidad Valenciana, Spain, 03550
    • Novartis Investigative Site Valencia, Comunidad Valenciana, Spain, 46010
    • Novartis Investigative Site Valencia, Comunidad Valenciana, Spain, 46014
  • Spain, Extremadura
    • Novartis Investigative Site Badajoz, Extremadura, Spain, 06080
    • Novartis Investigative Site Caceres, Extremadura, Spain, 10003
  • Spain, Galicia
    • Novartis Investigative Site A Coruna, Galicia, Spain, 15009
    • Novartis Investigative Site La Coruna, Galicia, Spain, 15006
    • Novartis Investigative Site Lugo, Galicia, Spain, 27003
  • Spain, Madrid
    • Novartis Investigative Site Fuenlabrada, Madrid, Spain, 28942
  • Spain, Murcia
    • Novartis Investigative Site El Palmar, Murcia, Spain, 30120
  • Spain, N Ap
    • Novartis Investigative Site Madrid, N Ap, Spain, 28034
  • Spain, Pais Vasco
    • Novartis Investigative Site San Sebastian, Pais Vasco, Spain, 20080
  • Spain, País Vasco
    • Novartis Investigative Site Vitoria-Gasteiz, País Vasco, Spain, 01009
  • Spain, Pontevedra
    • Novartis Investigative Site Vigo, Pontevedra, Spain, 36312
  • Spain, Santa Cruz De Tenerife
    • Novartis Investigative Site La Laguna, Santa Cruz De Tenerife, Spain, 38320
  • Spain,
    • Novartis Investigative Site Barcelona, , Spain, 08035
    • Novartis Investigative Site Bilbao, , Spain, 48013
    • Novartis Investigative Site Castellon, , Spain, 12002
    • Novartis Investigative Site Girona, , Spain, 17007
    • Novartis Investigative Site Granada, , Spain, 18013
    • Novartis Investigative Site Madrid, , Spain, 28009
    • Novartis Investigative Site Madrid, , Spain, 28033
    • Novartis Investigative Site Madrid, , Spain, 28040
    • Novartis Investigative Site Madrid, , Spain, 28222
    • Novartis Investigative Site Murcia, , Spain, 30008
    • Novartis Investigative Site Navarra, , Spain, 31008
    • Novartis Investigative Site Sabadell, , Spain, 08208
    • Novartis Investigative Site Valencia, , Spain, 46009
    • Novartis Investigative Site Zaragoza, , Spain, 50009
  • Taiwan,
    • Novartis Investigative Site Changhua, , Taiwan, 50006
    • Novartis Investigative Site Taichung, , Taiwan, 40447
    • Novartis Investigative Site Taichung, , Taiwan, 407
    • Novartis Investigative Site Tainan, , Taiwan, 70403
    • Novartis Investigative Site Taipei, , Taiwan, 10002
    • Novartis Investigative Site Taipei, , Taiwan, 10449
    • Novartis Investigative Site Taipei, , Taiwan, 11217
    • Novartis Investigative Site Taipei, , Taiwan,
    • Novartis Investigative Site Taoyuan, , Taiwan, 33305
  • United Kingdom, Cornwall
    • Novartis Investigative Site Truro, Cornwall, United Kingdom, TR1 3LJ
  • United Kingdom, Kent
    • Novartis Investigative Site Maidstone, Kent, United Kingdom, M16 9QQ
  • United Kingdom,
    • Novartis Investigative Site Cardiff, , United Kingdom, CF14 2TL
    • Novartis Investigative Site London, , United Kingdom, SE1 9RT
    • Novartis Investigative Site London, , United Kingdom, SM2 5PT
    • Novartis Investigative Site London, , United Kingdom, SW3 6JJ
    • Novartis Investigative Site Nottingham, , United Kingdom, NG5 1PB
    • Novartis Investigative Site Oxford, , United Kingdom, OX3 7LJ
    • Novartis Investigative Site Preston, , United Kingdom, PR2 9HT
    • Novartis Investigative Site Stoke-on-Trent, , United Kingdom, ST4 6QG

Sponsors and Collaborators

Novartis Pharmaceuticals

Translational Research in Oncology

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03701334
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Novartis:

early breast cancer (EBC)

HR+/HER2-

adjuvant

LEE011

ribociclib

CDK4/6 inhibitor

Additional relevant MeSH terms:

Breast Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020