Spots Global Cancer Trial Database for A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
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Trial Identification
Brief Title: A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
Official Title: A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer
Study ID: NCT02273973
Conditions
Study Description
Brief Summary: This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Breastlink Med Group Inc, Santa Ana, California, United States
MGH Cancer Center, Boston, Massachusetts, United States
MSKCC at Basking Ridge, Basking Ridge, New Jersey, United States
MSKCC @ Commack, Commack, New York, United States
MSKCC @ West Harrison, Harrison, New York, United States
Memorial Sloan-Kettering Cancer Center; Hematology/Oncology, New York, New York, United States
MSKC @ Rockville, Rockville Centre, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Kinghorn Cancer Centre; St Vincents Hospital, Darlinghurst, New South Wales, Australia
Newcastle Mater Misericordiae Hospital; Oncology, Waratah, New South Wales, Australia
Victorian Breast and Oncology Care, East Melbourne, Victoria, Australia
Cabrini Medical Centre; Oncology, Malvern, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie, Graz, , Austria
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie, Graz, , Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie, Innsbruck, , Austria
Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie, Linz, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Brustzentrum - Ordination Dr. Wette, St. Veit/Glan, , Austria
Klinikum Kreuzschwestern Wels; Iii. Interne Abt., Wels, , Austria
Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie, Wien, , Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie, Wien, , Austria
Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe, Wien, , Austria
Institut Jules Bordet, Brussels, , Belgium
CHU Brugmann (Victor Horta), Bruxelles, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Antwerpen, Edegem, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Clinica de Neoplasias Litoral, Itajai, SC, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia, São Paulo, SP, Brazil
Hospital Clinico Vina del Mar, Viña del Mar, , Chile
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
MULTISCAN, s.r.o., Radiologicke centrum Pardubice, Pardubice, , Czechia
Oblastni nemocnice Pribram, Pribram, , Czechia
Hospital Oncologia; Oncology, Salvador, , El Salvador
Centre Jean Perrin; Division De Recherche Clinique, Clermont Ferrand, , France
Centre Jean Bernard, Le Mans, , France
Institut Curie; Oncologie Medicale, Paris, , France
Hopital Saint Louis; Service Onco Thoracique, Paris, , France
Centre Rene Huguenin; ONCOLOGIE GENETIQUE, Saint Cloud, , France
CHI de Toulon - Hôpital Sainte Musse, Toulon, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, , France
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare), Berlin, , Germany
Studienzentrum Berlin City, Berlin, , Germany
Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum, Gelsenkirchen, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie, Hamburg, , Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hannover, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, , Germany
Rotkreuzklinikum München; Frauenklinik, Muenchen, , Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe, Münster, , Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik, Ulm, , Germany
Marien-Hospital Witten; Frauenklinik Brustzentrum, Witten, , Germany
Grupo Angeles, Guatemala City, , Guatemala
Centro Oncológico Sixtino / Centro Oncológico SA, Guatemala, , Guatemala
Szent Margit Hospital; Dept. of Oncology, Budapest, , Hungary
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika, Debrecen, , Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont, Kecskemet, , Hungary
B-A-Z County Hospital, Miskolc, , Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged, , Hungary
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna, Emilia-Romagna, Italy
Ospedale degli Infermi, Rimini, Emilia-Romagna, Italy
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico, Genova, Liguria, Italy
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia, Cremona, Lombardia, Italy
Ospedale Per Acuti Mater Salutis Di Legnago, Legnago, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica, Milano, Lombardia, Italy
National Cancer Center; Medical Oncology, Gyeonggi-do, , Korea, Republic of
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul, , Korea, Republic of
Yonsei University Severance Hospital; Medical Oncology, Seoul, , Korea, Republic of
Samsung Medical Centre; Division of Hematology/Oncology, Seoul, , Korea, Republic of
Centro Estatal de Cancerología, Chihuahua, , Mexico
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios, Distrito Federal, , Mexico
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco, Mexico City, , Mexico
Centro Oncologico America, Panama, , Panama
Hospital Nacional Cayetano Heredia; Hematology - Oncology, Lima, , Peru
Oncosalud Sac; Oncología, Lima, , Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional, Lima, , Peru
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii, Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdańsk, , Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii, Lodz, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii, Otwock, , Poland
Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie, Poznan, , Poland
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon, Warszawa, , Poland
IPO de Lisboa; Servico de Oncologia Medica, Lisboa, , Portugal
Centro Clinico Champalimaud; Oncologia Medica, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Instituto Universitario Dexeus; Servicio de Oncología, Barcelona, , Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia, Caceres, , Spain
Hospital Provincial de Castellon; Servicio de Oncologia, Castellon, , Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia, Girona, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lerida, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Clinico Universitario; Oncologia, Valencia, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia, , Spain
Fundación IVO, Valencia, , Spain
Kantonsspital Baden; Frauenklinik, Baden, , Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie, Chur, , Switzerland
Fondazione Oncologia Lago Maggiore, Locarno, , Switzerland
Royal Bournemouth General Hospital; Oncology, Bournemouth, , United Kingdom
Frimley Park Hospital; Breast Resaerch Team, Camberley, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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