Study Description

The trial will include pre and postmenopausal women and men with HR-positive, HER2-negative EBC, with an Anatomic Stage Group III, IIB or a subset of Stage IIA cases, after adequate surgical resection, radiotherapy (if indicated), adjuvant or neoadjuvant chemotherapy (if indicated), and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.

Approximately 5,000 patients will be randomized (using an Interactive Response Technology system [IRT]) into two treatment arms in a 1:1 ratio.

The trial will include screening, treatment, and follow up phases.

Condition or Disease	Intervention/Treatment
Early Breast Cancer	Drug: Ribociclib Other: Endocrine Therapy

Study Design

Study Type	Interventional
Actual Enrollment	5101 participants
Design Allocation	Randomized
Interventional 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)
Study Start Date	December 7, 2018
Anticipated Primary Completion Date	May 29, 2026
Anticipated Study Completion Date	May 29, 2026

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Ribociclib + Endocrine Therapy Participants will receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously	Drug: Ribociclib Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle Other: Endocrine Therapy
Endocrine Therapy Participants will receive endocrine therapy only once daily continuously	Other: Endocrine Therapy

Outcome Measures

Primary Outcome Measures

1. Invasive Disease-Free Survival (iDFS) [Up to approximately 91 months]
   iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. iDFS is defined as 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).

Secondary Outcome Measures

1. Recurrence-free survival (RFS) [Up to approximately 91 months]
   RFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials). RFS is defined as the time from date of randomization to date of first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, or death (any cause).
2. Distant disease-free survival (DDFS) [Up to approximately 91 months]
   DDFS using STEEP criteria. DDFS is defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
3. Overall Survival (OS) [Up to approximately 91 months]
   OS is defined as the time from date of randomization to date of death due to any cause.
4. Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30 [Up to approximately 91 months]
   The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
5. Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30 [Up to approximately 91 months]
   The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
6. PK parameters: Ctrough and other applicable parameters for ribociclib [Cycle 1 Day 15]
   Pharmacokinetics of ribociclib: Ctrough and other applicable parameters

Eligibility Criteria

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

Contacts and Locations

Sponsors and Collaborators	Novartis Pharmaceuticals, Translational Research in Oncology
	Translational Research in Oncology
Locations	University of Alabama at Birmingham-Kirklin Clinic | Birmingham, Alabama, United States, 35294-0006 Cancer Treatment Centers of America | Goodyear, Arizona, United States, 85338 St Bernards Medical Center | Jonesboro, Arkansas, United States, 72401 Comprehensive Blood and Cancer | 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 St. Jude Heritage Medical Group | Fullerton, California, United States, 92835 UCLA Hematology Oncology | Laguna Hills, California, United States, 92653 Southern CA Oncology Rsrch Alliance | Los Angeles, California, United States, 90057 Stanford University Medical Center | Palo Alto, California, United States, 94304-1509 UCLA Pasadena HC Hemato Onco | Pasadena, California, United States, 941105 UCLA Porter Ranch Hemato and Onco | Porter Ranch, California, United States, 91326 Cancer Care Associates Medical Grp | Redondo Beach, California, United States, 90277 Sharp Memorial Hospital | San Diego, California, United States, 92123 UCSF | San Francisco, California, United States, 94115 Central Coast Medical Oncology Corporation | Santa Maria, California, United States, 93454 UCLA Santa Monica Hematology Oncology | Santa Monica, California, United States, 90404 Lundquist Inst BioMed at Harbor | Torrance, California, United States, 90509-2910 UCLA Valencia | Valencia, California, United States, 91355 Valley Breast Care | Van Nuys, California, United States, 91405 UCLA Cancer Center Westlake Village | Westlake Village, California, United States, 91361 University Of Colorado Hospital | Aurora, Colorado, United States, 80045 Rocky Mountain Cancer Centers | Longmont, Colorado, United States, 80501 Hospital of Central Connecticut | New Britain, Connecticut, United States, 06052 Yale University School Of Medicine | New Haven, Connecticut, United States, 06520 Norwalk Hospital | Norwalk, Connecticut, United States, 06856 Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut, United States, 06360 Holy Cross Hospital-Ft. Lauderdale | Fort Lauderdale, Florida, United States, 33308 Florida Cancer Specialists | Fort Myers, Florida, United States, 33901 Memorial Cancer Institute | Hollywood, Florida, United States, 33021 Baptist MD Anderson Cancer Center | Jacksonville, Florida, United States, 32207 University of Miami | Miami, Florida, United States, 33136 Orlando Health Clinical Trials | Orlando, Florida, United States, 32806 Florida Cancer Specialists-North | Saint Petersburg, Florida, United States, 33705 Florida Cancer Specialists Pan | Tallahassee, Florida, United States, 32308 Florida Cancer Specialists | West Palm Beach, Florida, United States, 33401 Winship Cancer Institute of Emory University | Atlanta, Georgia, United States, 30322 Southeastern Regional Medical Center | Newnan, Georgia, United States, 30265 Cancer Treatment Centers of America | Zion, Illinois, United States, 60099 Cancer Care Center | New Albany, Indiana, United States, 47150 University of Kansas Cancer Center | Westwood, Kansas, United States, 66205 Cancer Center of Kansas | Wichita, Kansas, United States, 67214-3728 Norton Cancer Institute | Louisville, Kentucky, United States, 40202 Mercy Medical Center | Baltimore, Maryland, United States, 21202 Massachusetts General Hospital | Boston, Massachusetts, United States, 02114 University of Michigan Cancer Center | Ann Arbor, Michigan, United States, 48109 Fairview Health Services | Maple Grove, Minnesota, United States, 55369 Metro Minnesota CCOP | Saint Louis Park, Minnesota, United States, 55416 Park Nicollet Institute | Saint Louis Park, Minnesota, United States, 55416 Saint Lukes 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 St Vincent Frontier Cancer Center | Billings, Montana, United States, 59102 Saint Francis Medical Center | Grand Island, Nebraska, United States, 68803 Comprehensive Cancer Cntr Of Nevada | Henderson, Nevada, United States, 89052 Saint Barnabas Medical Center | Livingston, New Jersey, United States, 07039 Perlmutter Cancer Centre | New York, New York, United States, 10016 Randolph Medical Associates | Asheboro, North Carolina, United States, 27204 Cone Health Cancer Center | Greensboro, North Carolina, United States, 27403 Kaiser Permanente NW Region | Clackamas, Oregon, United States, 97015 Penn State Hershey Cancer Institute | Hershey, Pennsylvania, United States, 17033 Cancer Treatment Centers of America Eastern Regional Medical Center | Philadelphia, Pennsylvania, United States, 19124 The West Clinic | Germantown, Tennessee, United States, 38138 Sarah Cannon Research Institute | Nashville, Tennessee, United States, 37203 Baylor Charles A Sammons Cancer Cnt | Dallas, Texas, United States, 75246 Ctr For Cancer And Blood Disorders | Fort Worth, Texas, United States, 76104 MD Anderson Cancer Center University of Texas | Houston, Texas, United States, 77030 Utah Cancer Specialists | Salt Lake City, Utah, United States, 84106 Virginia Cancer Specialists | Fairfax, Virginia, United States, 22031 Virginia Cancer Institute | Richmond, Virginia, United States, 23230 Fred Hutchinson Cancer Center | Seattle, Washington, United States, 98109 University of Wisconsin Paul P Carbone Comp Cancer Center | Madison, Wisconsin, United States, 53792 6164 Novartis Investigative Site | Rosario, Santa Fe, Argentina, S2000 Novartis Investigative Site | Rosario, Sante Fe, Argentina, S200KZE Novartis Investigative Site | San Miguel De Tucuman, Tucuman, Argentina, T4000IAK Novartis Investigative Site | Rio Negro, Viedma, Argentina, 8500 Novartis Investigative Site | Caba, Argentina, C1419AHN Novartis Investigative Site | Cordoba, Argentina, X5004FHP Novartis Investigative Site | Jujuy, Argentina, 4600 Novartis Investigative Site | La Rioja, Argentina, 5300 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 | 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 Novartis Investigative Site | Auchenflower, Queensland, Australia, 4066 Novartis Investigative Site | Birtinya, Queensland, Australia, 4575 Novartis Investigative Site | Wooloongabba, Queensland, Australia, 4102 Novartis Investigative Site | Bedford Park, South Australia, Australia, 5041 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 Novartis Investigative Site | Murdoch, Western Australia, Australia, 6150 Novartis Investigative Site | Nedlands, Western Australia, Australia, 6009 Novartis Investigative Site | Liverpool, Australia, 2170 Novartis Investigative Site | Innsbruck, Tyrol, Austria, 6020 Novartis Investigative Site | Graz, Austria, 8036 Novartis Investigative Site | Linz, Austria, 4020 Novartis Investigative Site | Salzburg, Austria, 5020 Novartis Investigative Site | Wien, Austria, 1090 Novartis Investigative Site | Bruxelles, Belgium, 1000 Novartis Investigative Site | Bruxelles, Belgium, 1200 Novartis Investigative Site | Charleroi, Belgium, 6000 Novartis Investigative Site | Edegem, Belgium, 2650 Novartis Investigative Site | Hasselt, Belgium, 3500 Novartis Investigative Site | Jette, Belgium, 1090 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 Novartis Investigative Site | Londrina, PR, Brazil, 86015-520 Novartis Investigative Site | Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170 Novartis Investigative Site | Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 Novartis Investigative Site | Ijui, RS, Brazil, 98700-000 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 Novartis Investigative Site | Barretos, Sao Paulo, Brazil, 14784 400 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, 04014-002 Novartis Investigative Site | Caxias do Sul, Brazil, 95070-560 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 Novartis Investigative Site | Sao Paulo, Brazil, 01255-000 Novartis Investigative Site | Calgary, Alberta, Canada, T2N 4N2 Novartis Investigative Site | Edmonton, Alberta, Canada, T6G 1Z2 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 Novartis Investigative Site | Halifax, Nova Scotia, Canada, B3H 2Y9 Novartis Investigative Site | Kitchener, Ontario, Canada, N2G 1G3 Novartis Investigative Site | London, Ontario, Canada, N6A 5W9 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 Novartis Investigative Site | Fleurimont, Quebec, Canada, J1H 5N4 Novartis Investigative Site | Greenfield Park, Quebec, Canada, J4V 2H1 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 | St Jerome, Quebec, Canada, J7Z 5T3 Novartis Investigative Site | Quebec, Canada, G1S 4L8 Novartis Investigative Site | Guangzhou, Guangdong, China, 510000 Novartis Investigative Site | Shijiazhuang, Hebei, China, 050011 Novartis Investigative Site | Harbin, Heilongjiang, China, 150081 Novartis Investigative Site | Zhengzhou, Henan, China, 450008 Novartis Investigative Site | Wuhan, Hubei, China, 430022 Novartis Investigative Site | Nanjing, Jiangsu, China, 210029 Novartis Investigative Site | Suzhou, Jiangsu, China, 215004 Novartis Investigative Site | Chang Chun, Jilin, China, 130021 Novartis Investigative Site | Chengdu, Sichuan, China, 610041 Novartis Investigative Site | Hangzhou, Zhejiang, China, 310016 Novartis Investigative Site | Beijing, China, 100021 Novartis Investigative Site | Chongqing, China, 400016 Novartis Investigative Site | Shanghai, China, 200032 Novartis Investigative Site | Tianjin, China, 300480 Novartis Investigative Site | Zhenjiang, China, 310009 Novartis Investigative Site | Nice, Alpes Maritimes, France, 06189 Novartis Investigative Site | Dijon, Cote D Or, France, 21034 Novartis Investigative Site | Limoges, Haute Vienne, France, 87000 Novartis Investigative Site | Saint-Cloud, Hauts De Seine, France, 92210 Novartis Investigative Site | Rennes, Ille Et Vilaine, France, 35062 Novartis Investigative Site | Grenoble, Isere, France, 38028 Novartis Investigative Site | Lyon cedex 04, Rhone, France, 69317 Novartis Investigative Site | Amiens, France, 80000 Novartis Investigative Site | Angers 02, France, 49055 Novartis Investigative Site | Argenteuil, France, 95107 Novartis Investigative Site | Avignon, France, 84082 Novartis Investigative Site | Besancon Cedex, France, 25030 Novartis Investigative Site | Bordeaux, France, 33076 Novartis Investigative Site | Bron Cedex, France, 69677 Novartis Investigative Site | Caen, France, 14021 Novartis Investigative Site | Le Mans, France, 72000 Novartis Investigative Site | Marseille, France, 13008 Novartis Investigative Site | Montpellier, France, 34070 Novartis Investigative Site | Montpellier, France, 34298 Novartis Investigative Site | Nantes 2, France, 44202 Novartis Investigative Site | Paris 10, France, 75475 Novartis Investigative Site | Paris 13, France, 75651 Novartis Investigative Site | Paris, France, 75015 Novartis Investigative Site | Paris, France, 75231 Novartis Investigative Site | Paris, France, 75970 Novartis Investigative Site | Pierre Benite, France, 69495 Novartis Investigative Site | Rouen, France, 76038 Novartis Investigative Site | Saint Herblain, France, 44805 Novartis Investigative Site | Strasbourg, France, F 67085 Novartis Investigative Site | Toulouse, France, 31059 Novartis Investigative Site | Vandoeuvre-les-Nancy, France, 54519 Novartis Investigative Site | Villejuif, France, 94800 Novartis Investigative Site | Ravensburg, Baden Wuerttemberg, Germany, 88212 Novartis Investigative Site | Muenchen, Bavaria, Germany, 80637 Novartis Investigative Site | Georgsmarienhuette, Lower Saxony, Germany, 49124 Novartis Investigative Site | Hannover, Niedersachsen, Germany, 30177 Novartis Investigative Site | Essen, Nordrhein Westfalen, Germany, 45136 Novartis Investigative Site | Velbert, North Rhine-Westphalia, Germany, 42551 Novartis Investigative Site | Augsburg, Germany, 86150 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 | Essen, Germany, 45147 Novartis Investigative Site | Frankfurt, Germany, 60431 Novartis Investigative Site | Hamburg, Germany, 20357 Novartis Investigative Site | Kiel, Germany, 24105 Novartis Investigative Site | Mainz, Germany, 55131 Novartis Investigative Site | Mannheim, Germany, 68167 Novartis Investigative Site | Moenchengladbach, Germany, 41061 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 | Schweinfurt, Germany, 97422 Novartis Investigative Site | Tuebingen, Germany, 72076 Novartis Investigative Site | Ulm, Germany, 89081 Novartis Investigative Site | Wuerzburg, Germany, 97080 Novartis Investigative Site | Zalaegerszeg, Zala, Hungary, 8900 Novartis Investigative Site | Budapest, Hungary, H-1032 Novartis Investigative Site | Budapest, Hungary, H-1083 Novartis Investigative Site | Budapest, Hungary, H-1145 Novartis Investigative Site | Debrecen, Hungary, 4032 Novartis Investigative Site | Kecskemet, Hungary, 6001 Novartis Investigative Site | Pecs, Hungary, 7623 Novartis Investigative Site | Szeged, Hungary, 6720 Novartis Investigative Site | Szekszard, Hungary, 7100 Novartis Investigative Site | Szombathely, Hungary, H-9700 Novartis Investigative Site | Tatabanya, Hungary, H 2800 Novartis Investigative Site | Wilton, Cork, Ireland, T12 DC4A Novartis Investigative Site | County Limerick, Ireland, V94 F858 Novartis Investigative Site | Dublin 4, Ireland, DO4 Novartis Investigative Site | Dublin 7, Ireland, 533615 Novartis Investigative Site | Dublin, Ireland, D03 VX82 Novartis Investigative Site | Dublin, Ireland, DUBLIN 9 Novartis Investigative Site | Waterford, Ireland, 48346 Novartis Investigative Site | Ancona, AN, Italy, 60126 Novartis Investigative Site | Bergamo, BG, Italy, 24127 Novartis Investigative Site | Bologna, BO, Italy, 40138 Novartis Investigative Site | Catania, CT, Italy, 95123 Novartis Investigative Site | Milano, MI, Italy, 20133 Novartis Investigative Site | Rozzano, MI, Italy, 20089 Novartis Investigative Site | Palermo, PA, Italy, 90146 Novartis Investigative Site | Aviano, PN, Italy, 33081 Novartis Investigative Site | Roma, RM, Italy, 00128 Novartis Investigative Site | Candiolo, TO, Italy, 10060 Novartis Investigative Site | Napoli, Italy, 80131 Novartis Investigative Site | Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644 Novartis Investigative Site | Seoul, Daegu, Korea, Republic of, 41404 Novartis Investigative Site | Wonju-si, Gangwon-do, Korea, Republic of, 26426 Novartis Investigative Site | Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620 Novartis Investigative Site | Suwon si, Gyeonggi Do, Korea, Republic of, 16499 Novartis Investigative Site | Gyeonggi do, Korea, Korea, Republic of, 10408 Novartis Investigative Site | Seoul, Seocho Gu, Korea, Republic of, 06591 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, 03722 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 Novartis Investigative Site | Warsaw, Ul Roentgena 5, Poland, 02 781 Novartis Investigative Site | Bialystok, Poland, 15 027 Novartis Investigative Site | Gdynia, Poland, 81 519 Novartis Investigative Site | Gliwice, Poland, 44 101 Novartis Investigative Site | Grudziadz, Poland, 86 300 Novartis Investigative Site | Krakow, Poland, 31 501 Novartis Investigative Site | Lodz, Poland, 90-338 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 Novartis Investigative Site | Craiova, Dolj, Romania, 200347 Novartis Investigative Site | Craiova, Dolj, Romania, 200535 Novartis Investigative Site | Bucuresti, Romania, 011171 Novartis Investigative Site | Cluj-Napoca, Romania, 400124 Novartis Investigative Site | Timisoara, Romania, 300425 Novartis Investigative Site | St Petersburg, Saint Petersburg, Russian Federation, 195271 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 | Moscow, Russian Federation, 111123 Novartis Investigative Site | Moscow, Russian Federation, 115478 Novartis Investigative Site | Moscow, Russian Federation, 143423 Novartis Investigative Site | Nizhniy Novgorod, Russian Federation, 603137 Novartis Investigative Site | Novosibirsk, Russian Federation, 630000 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 | Saint Petersburg, Russian Federation, 191104 Novartis Investigative Site | St Petersburg, Russian Federation, 197758 Novartis Investigative Site | St Petersburg, Russian Federation, 198255 Novartis Investigative Site | Tyumen, Russian Federation, 625041 Novartis Investigative Site | Ufa, Russian Federation, 450054 Novartis Investigative Site | Yaroslavl, Russian Federation, 150054 Novartis Investigative Site | Elche, Alicante, Spain, 03203 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, 41009 Novartis Investigative Site | Sevilla, Andalucia, Spain, 41013 Novartis Investigative Site | Sabadell, Barcelona, Spain, 08208 Novartis Investigative Site | Salamanca, Castilla Y Leon, Spain, 37007 Novartis Investigative Site | Badalona, Catalunya, Spain, 08916 Novartis Investigative Site | Barcelona, Catalunya, Spain, 08035 Novartis Investigative Site | Barcelona, Catalunya, Spain, 08036 Novartis Investigative Site | Hospitalet de LLobregat, Catalunya, Spain, 08907 Novartis Investigative Site | Manresa, Catalunya, Spain, 08240 Novartis Investigative Site | Alicante, Comunidad Valenciana, Spain, 03550 Novartis Investigative Site | Castellon, Comunidad Valenciana, Spain, 12002 Novartis Investigative Site | Valencia, Comunidad Valenciana, Spain, 46009 Novartis Investigative Site | Valencia, Comunidad Valenciana, Spain, 46010 Novartis Investigative Site | Valencia, Comunidad Valenciana, Spain, 46014 Novartis Investigative Site | Badajoz, Extremadura, Spain, 06080 Novartis Investigative Site | Caceres, Extremadura, Spain, 10003 Novartis Investigative Site | A Coruna, Galicia, Spain, 15009 Novartis Investigative Site | La Coruna, Galicia, Spain, 15006 Novartis Investigative Site | Lugo, Galicia, Spain, 27003 Novartis Investigative Site | Fuenlabrada, Madrid, Spain, 28942 Novartis Investigative Site | El Palmar, Murcia, Spain, 30120 Novartis Investigative Site | Pamplona, Navarra, Spain, 31008 Novartis Investigative Site | Bilbao, Pais Vasco, Spain, 48013 Novartis Investigative Site | San Sebastian, Pais Vasco, Spain, 20080 Novartis Investigative Site | Vitoria Gasteiz, Pais Vasco, Spain, 01009 Novartis Investigative Site | Vigo, Pontevedra, Spain, 36212 Novartis Investigative Site | La Laguna, Santa Cruz De Tenerife, Spain, 38320 Novartis Investigative Site | Burgos, Spain, 09006 Novartis Investigative Site | Girona, Spain, 17007 Novartis Investigative Site | Granada, Spain, 18016 Novartis Investigative Site | Las Palmas de Gran Canaria, Spain, 35010 Novartis Investigative Site | Madrid, Spain, 28009 Novartis Investigative Site | Madrid, Spain, 28033 Novartis Investigative Site | Madrid, Spain, 28034 Novartis Investigative Site | Madrid, Spain, 28040 Novartis Investigative Site | Madrid, Spain, 28222 Novartis Investigative Site | Murcia, Spain, 30008 Novartis Investigative Site | Zaragoza, Spain, 50009 Novartis Investigative Site | Changhua, Taiwan, 50006 Novartis Investigative Site | Taichung, Taiwan, 40447 Novartis Investigative Site | Taichung, Taiwan, 407219 Novartis Investigative Site | Tainan, Taiwan, 70403 Novartis Investigative Site | Taipei, Taiwan, 10002 Novartis Investigative Site | Taipei, Taiwan, 103616 Novartis Investigative Site | Taipei, Taiwan, 10449 Novartis Investigative Site | Taipei, Taiwan, 11217 Novartis Investigative Site | Taoyuan, Taiwan, 33305 Novartis Investigative Site | Truro, Cornwall, United Kingdom, TR1 3LJ Novartis Investigative Site | Sutton, Surrey, United Kingdom, SM2 5PT Novartis Investigative Site | Cardiff, United Kingdom, CF14 2TL Novartis Investigative Site | London, United Kingdom, NW1 2BU Novartis Investigative Site | London, United Kingdom, SE1 9RT Novartis Investigative Site | London, United Kingdom, SW3 6JJ Novartis Investigative Site | Nottingham, United Kingdom, NG5 1PB Novartis Investigative Site | Oxford, United Kingdom, OX3 7LE Novartis Investigative Site | Preston, United Kingdom, PR2 9HT Novartis Investigative Site | Stoke-on-Trent, United Kingdom, ST4 6QG
Investigators

More Information

Additional Relevant MeSH Terms

• Breast Neoplasms
• Neoplasms by Site
• Neoplasms
• Breast Diseases
• Skin Diseases