Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Phase 3 – large-scale trial before approval
Conditions:
Breast Cancer
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Who can participate
Inclusion Criteria:
* Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
* The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
* The participant must have undergone definitive surgery of the primary breast tumor.
* The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
* Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:
* 4 or more positive axillary lymph nodes
* Tumor size of at least 5 centimeters
* Grade 3 defined as at least 8 points on the Bloom Richardson grading system
* Ki-67 index by central analysis of ≥20% on untreated breast tissue
* The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
* The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
* Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
* Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
* The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* The participant has adequate organ function.
* The participant is able to swallow oral medications.
Exclusion Criteria:
* Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease.
* Participants with inflammatory breast cancer.
* Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded.
* Females who are pregnant or lactating.
* The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
* The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
* The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene.
* The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
* The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE).
* The participant has active systemic infections or viral load.
* The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
Interventions
Abemaciclib
DRUG
Standard Adjuvant Endocrine Therapy
DRUG
Locations
619
Argentina (15)
Centro de Oncologia e Investigacion Buenos Aires
Berazategui , Buenos Aires
Hospital Aleman
Buenos Aires , Buenos Aires F.D.
Instituto Alexander Fleming
Buenos Aires
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas
Buenos Aires
Fundacion CENIT para la Investigacion en Neurociencias
CABA , Ciudad Autonoma Buenos Aires
Clinica Adventista de Belgrano
Ciudad Autonoma Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata , Buenos Aires
Hospital Universitario Austral
Pilar , Buenos Aires
Instituto de Oncologia de Rosario
Rosario , Santa Fe Province
Consultorio Dr. Miguel Ángel Escudero
Salta
CER San Juan
San Juan
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
San Miguel de Tucumán , Tucumán Province
Centro Medico San Roque
San Miguel de Tucumán
Clinica Viedma
Viedma , Río Negro Province
Australia (20)
Box Hill Hospital
Box Hill , Victoria
Mater Misericordiae Limited
Brisbane , Queensland
Chris O'Brien Lifehouse
Camperdown , New South Wales
St Vincent's Hospital
Darlinghurst , New South Wales
Epworth Hospital
East Melbourne , Victoria
Lyell McEwin Hospital
Elizabeth Vale , South Australia
Ashford Cancer Centre Research
Kurralta Park , South Australia
Launceston General Hospital
Launceston , Tasmania
Lismore Base Hospital
Lismore , New South Wales
Liverpool Hospital
Liverpool , New South Wales
Peter MacCallum Cancer Centre
Melbourne , Victoria
Maroondah Hospital
Melbourne , Victoria
Breast Cancer Research Centre WA
Nedlands , Western Australia
Gold Coast University Hospital
Southport , Queensland
St John of God Subiaco Hospital
Subiaco , Western Australia
Mater Hospital Sydney
Sydney , New South Wales
The Townsville Hospital
Townsville , Queensland
Calvary Mater Newcastle
Waratah , New South Wales
Westmead Hospital
Westmead , New South Wales
Southern Medical Day Care Centre
Wollongong , New South Wales
Austria (7)
Medizinische Universität Graz
Graz , Styria
Medizinische Universitaet Innsbruck
Innsbruck , Tyrol
Universitätsklinikum Salzburg
Salzburg
Private Practice - Dr. Hubalek
Schwaz , Tyrol
Medizinische Universität Wien
Vienna , State of Vienna
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna , State of Vienna
Klinik Hietzing
Vienna , State of Vienna
Belgium (17)
Algemeen Ziekenhuis klina
Brasschaat , Antwerpen
AZ Sint-Jan Brugge-Oostende AV
Bruges , West-Vlaanderen
Cliniques Universitaires Saint-Luc
Brussels , Bruxelles-Capitale, Région de
Antwerp University Hospital
Edegem , Antwerpen
Jessa Ziekenhuis
Hasselt , Limburg
Jan Yperman ziekenhuis
Ieper , West-Vlaanderen
AZ Groeninge Campus Kennedylaan
Kortrijk , West-Vlaanderen
Groupe Jolimont
La Louvière , Wallonne, Région
UZ Leuven
Leuven , Vlaams-Brabant
Centre Hospitalier D'Ardenne - Forget
Libramont , Luxembourg
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège , Liège
Clinical Chc Montlégia
Liège , Wallonne, Région
CHU de Charleroi - Hopital Civil Marie Curie
Lodelinsart , Hainaut
CHU UCL Namur/Site Sainte Elisabeth
Namur
Clinique Saint Pierre
Ottignies , Wallonne, Région
AZ Nikolaas
Sint-Niklaas , Oost-Vlaanderen
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir , Namur
Brazil (20)
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos , São Paulo
Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
Brasília , Federal District
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba , Paraná
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza , Ceará
Hospital Araújo Jorge
Goiânia , Goiás
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí , Rio Grande do Sul
Hospital Bruno Born
Lajeado , Rio Grande do Sul
Hospital de Cancer de Londrina
Londrina , Paraná
Hospital São Lucas da PUCRS
Porto Alegre , Rio Grande do Sul
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto , São Paulo
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro , Rio de Janeiro
INCA - Instituto Nacional Do Cancer
Rio de Janeiro
Faculdade de Medicina do ABC
Santo André , São Paulo
Hospital de Base de São José do Rio Preto
Sao Jose Rio Preto , São Paulo
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo , São Paulo
Hospital Sírio Libanês
São Paulo
Pérola Centro de Pesquisa em Oncologia
São Paulo
IBCC - Núcleo de Pesquisa e Ensino
São Paulo
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
São Paulo
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo
Canada (9)
Centre Hospitalier de l'Universite de Montreal
Montreal , Quebec
Jewish General Hospital
Montreal , Quebec
Hopital du Sacre-Coeur de Montreal
Montreal , Quebec
The Ottawa Hospital - General Campus
Ottawa , Ontario
CHU de Quebec-Hopital de Saint-Sacrement
Québec , Quebec
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitair -T
Sherbrooke , Quebec
North York General Hospital
Toronto , Ontario
Humber River Hospital
Toronto , Ontario
Unity Health Toronto, St. Michael's Hospital
Toronto , Ontario
China (16)
The Fifth Medical Center of PLA General Hospital
Beijing , Beijing Municipality
Beijing Cancer Hospital
Beijing , Beijing Municipality
Hunan Cancer Hospital
Changsha , Hunan
Fujian Medical University Union Hospital-1 Bingfanglou
Fuzhou , Fujian
Guangdong Provincial People's Hospital
Guangzhou , Guangdong
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou , Guangdong
Sun Yat-Sen University
Guangzhou , Guangdong
Zhejiang Cancer Hospital
Hangzhou , Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou , Zhejiang
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Shandong Cancer Hospital
Jinan , Shandong
Jiangsu Cancer Hospital
Nanjing , Jiangsu
Jiangsu Province Hospital
Nanjing , Nanjing
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai , Shanghai Municipality
Fudan University Shanghai Cancer Center
Shanghai , Shanghai Municipality
Henan Cancer Hospital
Zhengzhou , Henan
Czech Republic (6)
Masarykuv onkologicky ustav
Brno , Brno-město
Nemocnice Horovice
Hořovice , Beroun
Fakultni Nemocnice Ostrava
Ostrava , Moravian-Silesian Region
Multiscan
Pardubice , Pardubice Region
FN Plzen Lochotin
Pilsen
Fakultni Thomayerova nemocnice
Prague , Praha 4
Denmark (10)
Aalborg Universitetshospital, Syd
Aalborg , North Denmark
Aarhus Universitetshospital, Skejby
Aarhus , Central Jutland
Herlev and Gentofte Hospital
Copenhagen , Capital Region
Sydvestjysk Sygehus Esbjerg
Esbjerg , Region Syddanmark
Regionshospitalet Herning
Herning , Central Jutland
Rigshospitalet
København Ø , Capital Region
Næstved Sygehus
Næstved , Region Sjælland
Odense Universitetshospital
Odense , Region Syddanmark
Sygehus Soenderjylland
Sønderborg , Region Syddanmark
Vejle Sygehus
Vejle , Region Syddanmark
Finland (9)
Docrates Syöpäsairaala
Helsinki , Uusimaa
Keski-Suomen Keskussairaala
Jyväskylä , Central Finland
Kuopion Yliopistollinen Sairaala
Kuopio , Northern Savonia
Päijät-Häme Central hospital
Lahti
Oulun yliopistollinen sairaala
Oulu , North Ostrobothnia
Satakunnan Keskussairaala
Pori , Satakunta
Tampereen yliopistollinen sairaala
Tampere , Pirkanmaa
Turku University Central Hospital
Turku , Southwest Finland
Vaasan Keskussairaala
Vaasa , Pohjanmaa
France (17)
Sainte Catherine Institut du Cancer Avignon Provence
Avignon , Vaucluse
CHU de Besancon Hopital Jean Minjoz
Besançon , Doubs
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest , Brittany Region
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand , Puy-de-Dôme
Henri Mondor Hospital
Créteil , Seine-et-Marne
Centre Georges Francois Leclerc
Dijon , Côte-d'Or
Polyclinique De Blois
La Chaussée-Saint-Victor , Centre-Val de Loire
Centre Hospitalier de Vendee Les Oudairies
La Roche-sur-Yon , Vendée
Clinique Victor Hugo Le Mans
Le Mans , Pays de la Loire Region
Centre Leon Berard
Lyon , Auvergne-Rhône-Alpes
Centre de Cancérologie du Grand Montpellier
Montpellier , Languedoc-Roussillon
Polyclinique de Gentilly
Nancy , Meurthe-et-Moselle
Institut Curie
Paris
Hôpital Privé des Côtes d'Armor- HPCA
Plérin , Côtes-d'Armor
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Rennes , Ille-et-Vilaine
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen , Seine-Maritime
Institut de Cancérologie de l'Ouest
Saint-Herblain , Loire-Atlantique
Germany (33)
Klinikum St. Marien Amberg
Amberg , Bavaria
Gemeinschaftspraxis hop-augsburg
Augsburg , Bavaria
Helios Klinikum Berlin-Buch
Berlin
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim
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