Breast Cancer Clinical Trial
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
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
Full 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.
Eligibility Criteria
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
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There are 381 Locations for this study
Birmingham Alabama, 35294, United States
Goodyear Arizona, 85338, United States
Jonesboro Arkansas, 72401, United States
Bakersfield California, 93309, United States
Beverly Hills California, 90212, United States
Burbank California, 91505, United States
Encino California, 91436, United States
Laguna Hills California, 92653, United States
Los Angeles California, 90057, United States
Los Angeles California, 91405, United States
Palo Alto California, 94304, United States
Pasadena California, 94110, United States
Porter Ranch California, 91326, United States
Redondo Beach California, 90277, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Torrance California, 90509, United States
Valencia California, 91355, United States
Westlake Village California, 91361, United States
Yorba Linda California, 92886, United States
Aurora Colorado, 80045, United States
Greenwood Village Colorado, 80501, United States
New Britain Connecticut, 06052, United States
New Haven Connecticut, 06520, United States
Norwalk Connecticut, 06856, United States
Norwich Connecticut, 06360, United States
Fort Lauderdale Florida, 33308, United States
Fort Myers Florida, 33901, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30322, United States
Newnan Georgia, 30265, United States
Zion Illinois, 60099, United States
New Albany Indiana, 47150, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21202, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Maple Grove Minnesota, 55369, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63141, United States
Billings Montana, 59102, United States
Grand Island Nebraska, 68803, United States
Las Vegas Nevada, 89109, United States
Livingston New Jersey, 07039, United States
New York New York, 10016, United States
Asheboro North Carolina, 27204, United States
Burlington North Carolina, 27215, United States
Greensboro North Carolina, 27403, United States
Clackamas Oregon, 97015, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19124, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84106, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23230, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53792, United States
Rosario Santa Fe, S2000, Argentina
Rosario Sante Fe, S200K, Argentina
San Miguel De Tucuman Tucuman, T4000, Argentina
Rio Negro Viedma, 8500, Argentina
Caba , C1419, Argentina
Cordoba , X5004, Argentina
Jujuy , 4600, Argentina
La Rioja , 5300, Argentina
Campbelltown New South Wales, 2560, Australia
Coffs Harbour New South Wales, 2450, Australia
Darlinghurst New South Wales, 2010, Australia
Kingswood New South Wales, 2747, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
North Ryde New South Wales, 2109, Australia
St Leonards New South Wales, 2065, Australia
Wahroonga New South Wales, 2076, Australia
Westmead New South Wales, 2145, Australia
Auchenflower Queensland, 4066, Australia
Birtinya Queensland, 4575, Australia
Wooloongabba Queensland, 4102, Australia
Bedford Park South Australia, 5042, Australia
Bendigo Victoria, 3550, Australia
East Melbourne Victoria, 3002, Australia
Epping Victoria, 3076, Australia
Fitzroy Victoria, 3065, Australia
Franston Victoria, 3199, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Shepparton Victoria, 3630, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Graz Styria, 8036, Austria
Innsbruck Tyrol, 6020, Austria
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Edegem Antwerpen, 2650, Belgium
Bruxelles , 1000, Belgium
Bruxelles , 1090, Belgium
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Hasselt , 3500, Belgium
Leuven , 3000, Belgium
Libramont , 6800, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Yvoir , 5530, Belgium
Londrina PR, 86015, Brazil
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Ijuà RS, 98700, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 90560, Brazil
Porto Alegre RS, 90880, Brazil
Barretos Sao Paulo, 14784, Brazil
Santo Andre SP, 09060, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 03102, Brazil
Caxias do Sul , 95070, Brazil
Passo Fundo , 99010, Brazil
Piracicaba , 13419, Brazil
Recife , 50040, Brazil
Rio De Janeiro , 20560, Brazil
Salvador , 41810, Brazil
Sao Paulo , 01255, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
North Vancouver British Columbia, V7L 2, Canada
Surrey British Columbia, V3V 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Kitchener Ontario, N2G 1, Canada
London Ontario, N6A 4, Canada
Newmarket Ontario, J7Y 2, Canada
Oshawa Ontario, L1G 2, Canada
Sault Ste Marie Ontario, P6B 0, Canada
Sudbury Ontario, P3E 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Windsor Ontario, N8W 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
St-Jerome Quebec, J7Z 5, Canada
Quebec , G1S 4, Canada
Shijiazhuang Hebei, 05001, China
Harbin Heilongjiang, 15008, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Suzhou Jiangsu, 21500, China
Chang Chun Jilin, 13002, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31001, China
Beijing , 10002, China
Chongqing , 40001, China
Guangzhou , 51000, China
Nanjing , 21003, China
Shanghai , 20003, China
Zhenjiang , , China
Nice Cedex 2 Alpes Maritimes, 06189, France
Dijon Cedex Cote D Or, 21034, France
Limoges cedex Haute Vienne, 87000, France
Saint-Cloud Hauts De Seine, 92210, France
Rennes Cedex Ille Et Vilaine, 35062, France
Amiens , 80000, France
Angers Cedex 02 , 49055, France
Argenteuil , 95107, France
Avignon Cedex , 84082, France
Besancon cedex , 25030, France
Bordeaux Cedex , 33076, France
Caen Cedex , 14021, France
Grenoble cedex , 38028, France
Le Mans , 72000, France
Lyon , 69317, France
Lyon , 69677, France
Marseille , 13008, France
Montpellier Cedex 5 , 34298, France
Montpellier , 34070, France
Nantes cedex 2 , 44202, France
Paris Cedex 10 , 75475, France
Paris Cedex 13 , 75651, France
Paris , 75015, France
Paris , 75231, France
Paris , 75970, France
Pierre Benite Cedex , 69495, France
Rouen Cedex 1 , 76038, France
Saint Herblain cedex , 44805, France
Strasbourg , F 670, France
Toulouse Cedex 9 , 31059, France
Vandoeuvre-les-Nancy cedex , 54519, France
Villejuif Cedex , 94800, France
Ravensburg Baden-Wuerttemberg, 88212, Germany
Muenchen Bavaria, 80637, Germany
Georgsmarienhuette Lower Saxony, 49124, Germany
Hannover Niedersachsen, 30177, Germany
Essen Nordrhein-Westfalen, 45136, Germany
Velbert North Rhine-westphalia, 42551, Germany
Augsburg , 86150, Germany
Bad Liebenwerda , 04924, Germany
Berlin , 13125, Germany
Bonn , 53111, Germany
Bottrop , 46236, Germany
Cottbus , 03048, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Frankfurt , 60431, Germany
Hamburg , 20357, Germany
Kiel , 24105, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Moenchengladbach , 41061, Germany
Muenchen , 81377, Germany
Muenster , 48149, Germany
Munchen , 81675, Germany
Regensburg , 93053, Germany
Schweinfurt , 97422, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Wuerzburg , 97080, Germany
Zalaegerszeg Zala, 8900, Hungary
Budapest , 1085, Hungary
Budapest , 1145, Hungary
Budapest , H-103, Hungary
Debrecen , 4032, Hungary
Kecskemet , 6000, Hungary
Pecs , 7623, Hungary
Szeged , 6725, Hungary
Szekszard , 7100, Hungary
Szombathely , 9700, Hungary
Tatabanya , H 280, Hungary
Wilton Cork, , Ireland
Dublin 9 D9, , Ireland
County Limerick , V94 F, Ireland
Dublin 4 , , Ireland
Dublin 7 , , Ireland
Dublin , 8, Ireland
Waterford , , Ireland
Torrette AN Ancona, 60126, Italy
Bergamo BG, 24127, Italy
Catania CT, 95123, Italy
Milano MI, 20133, Italy
Rozzano MI, 20089, Italy
Palermo PA, 90146, Italy
Aviano PN, 33081, Italy
Roma RM, 00128, Italy
Candiolo TO, 10060, Italy
Bologna , 40138, Italy
Napoli , 80131, Italy
Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
Seoul Daegu, 41404, Korea, Republic of
Wonju-si Gangwon-do, 26426, Korea, Republic of
Bundang Gu Gyeonggi Do, 13620, Korea, Republic of
Gyeonggi do Korea, 10408, Korea, Republic of
Seoul Korea, 03722, Korea, Republic of
Suwon Kyonggi Do, 16499, Korea, Republic of
Seoul Seocho Gu, 06591, Korea, Republic of
Incheon , 22332, Korea, Republic of
Incheon , 405 7, Korea, Republic of
Seongnam Si Gyeonggi Do , 463-7, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 158-7, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Warsaw Ul Roentgena 5, 02 78, Poland
Bialystok , 15 02, Poland
Gdynia , 81 51, Poland
Gliwice , 44 10, Poland
Grudziadz , 86 30, Poland
Krakow , 31 50, Poland
Lodz , 90 24, Poland
Lublin , 20 09, Poland
Opole , 45 05, Poland
Ostroleka , 07 41, Poland
Otwock , 05 40, Poland
Wieliszew , 05 13, Poland
Wroclaw , 53 41, Poland
Craiova Dolj, 20034, Romania
Craiova Dolj, 20053, Romania
Bucuresti , 01117, Romania
Cluj-Napoca , 40012, Romania
Timisoara , 30023, Romania
Leningrad Region Russia, 18866, Russian Federation
St Petersburg Saint Petersburg, 19527, Russian Federation
Chelyabinsk , 45408, Russian Federation
Kazan , 42002, Russian Federation
Kostroma , 15600, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Moscow , 11112, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 14342, Russian Federation
Nizhny Novgorod , 60313, Russian Federation
Novosibirsk , , Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Orenburg , 46002, Russian Federation
Rostov-na-Donu , 34403, Russian Federation
Ryazan , 39001, Russian Federation
St Petersburg , 19775, Russian Federation
St- Petersburg , 19702, Russian Federation
Tyumen , 62504, Russian Federation
Ufa , 45005, Russian Federation
Yaroslavl , 15005, Russian Federation
Elche Alicante, 03203, Spain
Cordoba Andalucia, 14004, Spain
Granada Andalucia, 18014, Spain
Huelva Andalucia, 21005, Spain
Jaen Andalucia, 23007, Spain
Malaga Andalucia, 29010, Spain
Sevilla Andalucia, 41013, Spain
Sevilla Andalucia, 41017, Spain
Sabadell Barcelona, 08208, Spain
Burgos Castilla Y Leon, 09006, Spain
Salamanca Castilla Y Leon, 37007, Spain
Badalona Catalunya, 08916, Spain
Barcelona Catalunya, 08035, Spain
Barcelona Catalunya, 08036, Spain
Manresa Catalunya, 08240, Spain
Barcelona Cataluña, 08907, Spain
Alicante Comunidad Valenciana, 03550, Spain
Valencia Comunidad Valenciana, 46010, Spain
Valencia Comunidad Valenciana, 46014, Spain
Badajoz Extremadura, 06080, Spain
Caceres Extremadura, 10003, Spain
A Coruna Galicia, 15009, Spain
La Coruna Galicia, 15006, Spain
Lugo Galicia, 27003, Spain
Fuenlabrada Madrid, 28942, Spain
El Palmar Murcia, 30120, Spain
Pamplona Navarra, 31008, Spain
San Sebastian Pais Vasco, 20080, Spain
Vitoria-Gasteiz PaÃs Vasco, 01009, Spain
Vigo Pontevedra, 36312, Spain
La Laguna Santa Cruz De Tenerife, 38320, Spain
Bilbao , 48013, Spain
Castellon , 12002, Spain
Girona , 17007, Spain
Granada , 18013, Spain
Las Palmas de Gran Canaria , 35010, Spain
Madrid , 28009, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28222, Spain
Murcia , 30008, Spain
Valencia , 46009, Spain
Zaragoza , 50009, Spain
Changhua , 50006, Taiwan
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 10449, Taiwan
Taipei , 11217, Taiwan
Taipei , , Taiwan
Taoyuan , 33305, Taiwan
Truro Cornwall, TR1 3, United Kingdom
Cardiff , CF14 , United Kingdom
London , NW1 2, United Kingdom
London , SE1 9, United Kingdom
London , SM2 5, United Kingdom
London , SW3 6, United Kingdom
Nottingham , NG5 1, United Kingdom
Oxford , OX3 7, United Kingdom
Preston , PR2 9, United Kingdom
Stoke-on-Trent , ST4 6, United Kingdom
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