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

Early Breast Cancer Clinical Trial

— NATALEE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03701334
• Other study ID #: CLEE011O12301C
• Secondary ID: 2018-002998-21
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 7, 2018
• Est. completion date: May 29, 2026

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5101
• Est. completion date: May 29, 2026
• Est. primary completion date: May 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Drug:
• Ribociclib
Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

Other:
• Endocrine Therapy
ET will be administered according to the local clinical guidelines and current local prescribing information

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Jujuy
Argentina	Novartis Investigative Site	La Rioja
Argentina	Novartis Investigative Site	Rio Negro	Viedma
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Sante Fe
Argentina	Novartis Investigative Site	San Miguel De Tucuman	Tucuman
Australia	Novartis Investigative Site	Auchenflower	Queensland
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Bendigo	Victoria
Australia	Novartis Investigative Site	Birtinya	Queensland
Australia	Novartis Investigative Site	Campbelltown	New South Wales
Australia	Novartis Investigative Site	Coffs Harbour	New South Wales
Australia	Novartis Investigative Site	Darlinghurst	New South Wales
Australia	Novartis Investigative Site	East Melbourne	Victoria
Australia	Novartis Investigative Site	Epping	Victoria
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Franston	Victoria
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Kingswood	New South Wales
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Murdoch	Western Australia
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	North Ryde	New South Wales
Australia	Novartis Investigative Site	Shepparton	Victoria
Australia	Novartis Investigative Site	St Leonards	New South Wales
Australia	Novartis Investigative Site	Wahroonga	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Australia	Novartis Investigative Site	Wooloongabba	Queensland
Austria	Novartis Investigative Site	Graz	Styria
Austria	Novartis Investigative Site	Innsbruck	Tyrol
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Edegem	Antwerpen
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Libramont
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Namur
Belgium	Novartis Investigative Site	Wilrijk
Belgium	Novartis Investigative Site	Yvoir
Brazil	Novartis Investigative Site	Barretos	Sao Paulo
Brazil	Novartis Investigative Site	Caxias do Sul
Brazil	Novartis Investigative Site	Ijuí	RS
Brazil	Novartis Investigative Site	Londrina	PR
Brazil	Novartis Investigative Site	Passo Fundo
Brazil	Novartis Investigative Site	Piracicaba
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Recife
Brazil	Novartis Investigative Site	Rio De Janeiro
Brazil	Novartis Investigative Site	Salvador
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Kelowna	British Columbia
Canada	Novartis Investigative Site	Kitchener	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	North Vancouver	British Columbia
Canada	Novartis Investigative Site	Oshawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Sault Ste Marie	Ontario
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St Jerome	Quebec
Canada	Novartis Investigative Site	Sudbury	Ontario
Canada	Novartis Investigative Site	Surrey	British Columbia
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Windsor	Ontario
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Chang Chun	Jilin
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Nanjing
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Zhengzhou	Henan
China	Novartis Investigative Site	Zhenjiang
France	Novartis Investigative Site	Amiens
France	Novartis Investigative Site	Angers Cedex 02
France	Novartis Investigative Site	Argenteuil
France	Novartis Investigative Site	Avignon
France	Novartis Investigative Site	Besancon cedex
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Bron Cedex
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Dijon	Cote D Or
France	Novartis Investigative Site	Grenoble cedex
France	Novartis Investigative Site	Le Mans
France	Novartis Investigative Site	Limoges	Haute Vienne
France	Novartis Investigative Site	Lyon cedex 04	Rhone
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Montpellier Cedex 5
France	Novartis Investigative Site	Nantes cedex 2
France	Novartis Investigative Site	Nice Cedex 2	Alpes Maritimes
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris 10
France	Novartis Investigative Site	Paris 13
France	Novartis Investigative Site	Pierre Benite
France	Novartis Investigative Site	Rennes Cedex	Ille Et Vilaine
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Saint Herblain
France	Novartis Investigative Site	Saint-Cloud	Hauts De Seine
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Vandoeuvre-les-Nancy
France	Novartis Investigative Site	Villejuif
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Liebenwerda
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bottrop
Germany	Novartis Investigative Site	Cottbus
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Georgsmarienhuette	Lower Saxony
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Moenchengladbach
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen	Bavaria
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Ravensburg	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Schweinfurt
Germany	Novartis Investigative Site	Tuebingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Velbert	North Rhine-Westphalia
Germany	Novartis Investigative Site	Wuerzburg
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kecskemet
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szekszard
Hungary	Novartis Investigative Site	Szombathely
Hungary	Novartis Investigative Site	Tatabanya
Hungary	Novartis Investigative Site	Zalaegerszeg	Zala
Ireland	Novartis Investigative Site	County Limerick
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin 4
Ireland	Novartis Investigative Site	Dublin 7
Ireland	Novartis Investigative Site	Dublin 9	D9
Ireland	Novartis Investigative Site	Waterford
Ireland	Novartis Investigative Site	Wilton	Cork
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Candiolo	TO
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Torrette AN	AN
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Cheongju si	Chungcheongbuk Do
Korea, Republic of	Novartis Investigative Site	Gyeonggi do	Korea
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Seongnam Si Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Daegu
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Suwon	Kyonggi Do
Korea, Republic of	Novartis Investigative Site	Ulsan
Korea, Republic of	Novartis Investigative Site	Wonju-si	Gangwon-do
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gliwice
Poland	Novartis Investigative Site	Grudziadz
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Opole
Poland	Novartis Investigative Site	Ostroleka
Poland	Novartis Investigative Site	Otwock
Poland	Novartis Investigative Site	Warsaw	Ul Roentgena 5
Poland	Novartis Investigative Site	Wieliszew
Poland	Novartis Investigative Site	Wroclaw
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Craiova	Dolj
Romania	Novartis Investigative Site	Craiova	Dolj
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kostroma
Russian Federation	Novartis Investigative Site	Krasnoyarsk
Russian Federation	Novartis Investigative Site	Leningrad Region	Russia
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Obninsk
Russian Federation	Novartis Investigative Site	Omsk
Russian Federation	Novartis Investigative Site	Orenburg
Russian Federation	Novartis Investigative Site	Rostov-na-Donu
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg	Saint Petersburg
Russian Federation	Novartis Investigative Site	St- Petersburg
Russian Federation	Novartis Investigative Site	Tyumen
Russian Federation	Novartis Investigative Site	Ufa
Russian Federation	Novartis Investigative Site	Yaroslavl
Spain	Novartis Investigative Site	A Coruna	Galicia
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Badajoz	Extremadura
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Burgos	Castilla Y Leon
Spain	Novartis Investigative Site	Caceres	Extremadura
Spain	Novartis Investigative Site	Castellon
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	El Palmar	Murcia
Spain	Novartis Investigative Site	Elche	Alicante
Spain	Novartis Investigative Site	Fuenlabrada	Madrid
Spain	Novartis Investigative Site	Girona
Spain	Novartis Investigative Site	Granada
Spain	Novartis Investigative Site	Granada	Andalucia
Spain	Novartis Investigative Site	Huelva	Andalucia
Spain	Novartis Investigative Site	Jaen	Andalucia
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Lugo	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid	Andalucia
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Manresa	Catalunya
Spain	Novartis Investigative Site	Murcia
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	San Sebastian	Pais Vasco
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Vigo	Pontevedra
Spain	Novartis Investigative Site	Vitoria Gasteiz	Pais Vasco
Spain	Novartis Investigative Site	Zaragoza
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tainan
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Oxford
United Kingdom	Novartis Investigative Site	Preston
United Kingdom	Novartis Investigative Site	Stoke-on-Trent
United Kingdom	Novartis Investigative Site	Truro	Cornwall
United States	University of Michigan Cancer Center .	Ann Arbor	Michigan
United States	Randolph Medical Associates .	Asheboro	North Carolina
United States	Winship Cancer Institute of Emory University .	Atlanta	Georgia
United States	University of Colorado Hospital .	Aurora	Colorado
United States	Comprehensive Blood and Cancer SC-2	Bakersfield	California
United States	Mercy Medical Center .	Baltimore	Maryland
United States	UCLA Beverly Hills	Beverly Hills	California
United States	St Vincent Frontier Cancer Center .	Billings	Montana
United States	University of Alabama at Birmingham/ Kirklin Clinic .	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	UCLA Burbank	Burbank	California
United States	Kaiser Permanente NW Region .	Clackamas	Oregon
United States	Baylor Charles A. Sammons Cancer Center .	Dallas	Texas
United States	Encino Research Center .	Encino	California
United States	Virginia Cancer Specialists .	Fairfax	Virginia
United States	Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01	Fort Lauderdale	Florida
United States	Florida Cancer Specialists .	Fort Myers	Florida
United States	Center for Cancer and Blood Disorders Research Department	Fort Worth	Texas
United States	St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr	Fullerton	California
United States	The West Clinic .	Germantown	Tennessee
United States	Cancer Treatment Centers of America .	Goodyear	Arizona
United States	Saint Francis Medical Center .	Grand Island	Nebraska
United States	Cone Health Cancer Center .	Greensboro	North Carolina
United States	Comprehensive Cancer Centers of Nevada .	Henderson	Nevada
United States	Penn State Hershey Cancer Institute .	Hershey	Pennsylvania
United States	Memorial Cancer Institute .	Hollywood	Florida
United States	MD Anderson Cancer Center/University of Texas .	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	St Bernards Medical Center	Jonesboro	Arkansas
United States	HCA Midwest Division .	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	UCLA Hematology Oncology .	Laguna Hills	California
United States	Saint Barnabas Medical Center .	Livingston	New Jersey
United States	Rocky Mountain Cancer Centers .	Longmont	Colorado
United States	Southern California Oncology Research Alliance SCORA .	Los Angeles	California
United States	Valley Breast Care and Women s Health Center	Los Angeles	California
United States	Norton Cancer Institute .	Louisville	Kentucky
United States	University of Wisconsin / Paul P. Carbone Comp Cancer Center .	Madison	Wisconsin
United States	Fairview Health Services	Maple Grove	Minnesota
United States	University of Miami	Miami	Florida
United States	Sarah Cannon Research Institute .	Nashville	Tennessee
United States	Cancer Care Center .	New Albany	Indiana
United States	Hospital of Central Connecticut .	New Britain	Connecticut
United States	Yale University School Of Medicine .	New Haven	Connecticut
United States	Perlmutter Cancer Centre	New York	New York
United States	Southeastern Regional Medical Center	Newnan	Georgia
United States	Norwalk Hospital Pulmonary Medicine	Norwalk	Connecticut
United States	Eastern Connecticut Hematology and Oncology Associates Regulatory	Norwich	Connecticut
United States	Orlando Health Clinical Trials Orlando Health Inc	Orlando	Florida
United States	Stanford University Medical Center .	Palo Alto	California
United States	UCLA Pasadena Health Care Hematology Oncology .	Pasadena	California
United States	Cancer Treatment Centers of America Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	UCLA Porter Ranch Hematology and Oncology .	Porter Ranch	California
United States	Cancer Care Associates Medical Group	Redondo Beach	California
United States	Virginia Cancer Institute .	Richmond	Virginia
United States	David C Pratt Cancer Center	Saint Louis	Missouri
United States	Metro Minnesota CCOP Metro Minneapolis CCOP	Saint Louis Park	Minnesota
United States	Park Nicollet Institute .	Saint Louis Park	Minnesota
United States	Florida Cancer Specialists-North .	Saint Petersburg	Florida
United States	Utah Cancer Specialists .	Salt Lake City	Utah
United States	Sharp Memorial Hospital Regulatory	San Diego	California
United States	University of California San Francisco .	San Francisco	California
United States	Central Coast Medical Oncology Corporation Onc Dept	Santa Maria	California
United States	UCLA Santa Monica Hematology / Oncology Regulatory-2	Santa Monica	California
United States	Fred Hutchinson Cancer Center Medical Oncology	Seattle	Washington
United States	Florida Cancer Specialists Pan	Tallahassee	Florida
United States	Lundquist Inst BioMed at Harbor .	Torrance	California
United States	UCLA Valencia	Valencia	California
United States	Florida Cancer Specialists- East Region .	West Palm Beach	Florida
United States	UCLA Cancer Center, Westlake Village .	Westlake Village	California
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Cancer Treatment Centers of America .	Zion	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Translational Research in Oncology

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  France,  Germany,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-Free Survival (iDFS)	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).	Up to approximately 91 months
Secondary	Recurrence-free survival (RFS)	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).	Up to approximately 91 months
Secondary	Distant disease-free survival (DDFS)	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).	Up to approximately 91 months
Secondary	Overall Survival (OS)	OS is defined as the time from date of randomization to date of death due to any cause.	Up to approximately 91 months
Secondary	Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30	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.	Up to approximately 91 months
Secondary	Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30	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.	Up to approximately 91 months
Secondary	PK parameters: Ctrough and other applicable parameters for ribociclib	Pharmacokinetics of ribociclib: Ctrough and other applicable parameters	Cycle 1 Day 15