Tutkimus, jossa arvioitiin Giredestrant Plus everolimuusin tehoa ja turvallisuutta verrattuna Exemestane Plus everolimuusiin osallistujilla, joilla on estrogeenireseptoripositiivinen, HER2-negatiivinen, paikallisesti edennyt tai metastaattinen rintasyöpä (evERA Breast Cancer)
Vaiheen III, satunnaistettu, avoin, monikeskustutkimus, jossa arvioitiin Giredestrant Plus everolimuusin tehoa ja turvallisuutta verrattuna Exemestane Plus everolimuusiin potilailla, joilla on estrogeenireseptoripositiivinen, HER2-negatiivinen, paikallisesti edennyt tai metastaattinen rintasyöpä
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Laajennettu käyttöoikeus
Yhteystiedot ja paikat
Opiskelupaikat
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Ciudad Autonoma Buenos Aires, Argentiina, C1426ABP
- Consultorios Médicos Dr. Doreski
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Mendoza, Argentiina, M5500AYB
- Fundacion Centro Oncologico de Integracion Regional (COIR)
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Rosario, Argentiina, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
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Rosario, Argentiina, S2002KDS
- Hospital Provincial del Centenario
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Rosario, Argentiina, S2013KZE
- Instituto de Oncologia de Rosario
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San Juan, Argentiina, J5402DIL
- Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
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San Nicolás, Argentiina, C1015ABO
- Organizacion Medica de Investigacion
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Viedma, Argentiina, R8500ACE
- Centro de Investigación Clínica ? Clínica Viedma
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Ciudad Autónoma de BuenosAires
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Agronomía, Ciudad Autónoma de BuenosAires, Argentiina, C1417DTB
- Instituto de Oncología Ángel H. Roffo
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentiina, C1113AAE
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
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Córdoba Province
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Córdoba, Córdoba Province, Argentiina, X5008AAC
- Centro Medico Privado CEMAIC
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BARCELONA
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Barcelona, BARCELONA, Espanja, 08028
- Hospital Dexeus
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Barcelona, BARCELONA, Espanja, 08036
- Hospital Clinic de Barcelona
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CORDOBA
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Córdoba, CORDOBA, Espanja, 14004
- C.H. Regional Reina Sofia - PPDS
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LA CORUNA
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A Coruña, LA CORUNA, Espanja, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
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Madrid
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Madrid, Madrid, Espanja, 28040
- Hospital Clinico San Carlos
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Madrid, Madrid, Espanja, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, Espanja, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Madrid, Espanja, 28007
- Hospital General Universitario Gregorio Marañon
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Murcia
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Murcia, Murcia, Espanja, 30008
- Hospital General Universitario J.M Morales Meseguer
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Valencia
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Valencia, Valencia, Espanja, 46010
- Hospital Clinico Universitario de Valencia
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Cheongju-si, Etelä -Korea, 28644
- Chungbuk National University Hospital
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Dongnam-gu, Cheonan-si, Etelä -Korea, 31151
- Soon Chun Hyang University Cheonan Hospital
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Goyang-si, Etelä -Korea, 10408
- National Cancer Center
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Seongnam-si, Etelä -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Etelä -Korea, 03080
- Seoul National University Hospital
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Seoul, Etelä -Korea, 08308
- Korea University Guro Hospital
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Seoul, Etelä -Korea, 03722
- Severance Hospital Yonsei University Health System - PPDS
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Johannesburg, Etelä-Afrikka, 2196
- Medical Oncology Centre of Rosebank
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Emilia-Romagna
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Modena, Emilia-Romagna, Italia, 41110
- Azienda Ospedaliero - Universitaria di Modena Policlinico
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Lazio
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Rome, Lazio, Italia, 00144
- Istituto Nazionale Tumori Regina Elena IRCCS
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Liguria
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Genoa, Liguria, Italia, 16132
- IRCCS AOM Azienda Ospedaliera Metropolitana
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Lombardy
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Milan, Lombardy, Italia, 20162
- Asst Grande Ospedale Metropolitano Niguarda
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The Marches
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Torrette Di Ancona, The Marches, Italia, 60126
- Azienda Ospedaliero Universitaria Ospedali Riuniti
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Veneto
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Verona, Veneto, Italia, 37124
- "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
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Aichi, Japani, 464-8681
- Aichi Cancer Center
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Aichi, Japani, 466-8560
- Nagoya University Hospital
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Chiba, Japani, 260-8717
- Chiba Cancer Center
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Chiba, Japani, 277-8577
- National Cancer Center Hospital East
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Ehime, Japani, 791-0280
- Shikoku Cancer Center
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Hiroshima, Japani, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Hiroshima, Japani, 734-8551
- Hiroshima University Hospital
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Hokkaido, Japani, 060-8648
- Hokkaido University Hospital
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Hyōgo, Japani, 673-0021
- Hyogo Cancer Center
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Ibaraki, Japani, 305-8576
- University of Tsukuba Hospital
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Kanagawa, Japani, 241-8515
- Kanagawa Cancer Center
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Kanagawa, Japani, 259-1193
- Tokai University Hospital
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Kumamoto, Japani, 860-8556
- Kumamoto University Hospital
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Niigata, Japani, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japani, 540-0006
- National Hospital Organization Osaka National Hospital
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Tokyo, Japani, 135-8550
- The Cancer Institute Hospital of JFCR
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Tokyo, Japani, 113-8431
- Juntendo University Hospital
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Athens, Kreikka, 12464
- Attikon University General Hospital
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Athens, Kreikka, 115 27
- University of Athens, Hematological Clinic,
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Cholargós, Kreikka, 155 62
- Metropolitan General Hospital
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Heraklio, Kreikka, 711 10
- University General Hospital of Heraklion
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Larissa, Kreikka, 412 21
- University General Hospital of Larissa
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Marousi, Kreikka, 151 23
- IASO Obstetrics Gynecology Clinic
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Panórama, Kreikka, 552 36
- Agios Loucas Clinic SA
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Piraeus, Kreikka, 185 37
- Metaxa Cancer Hospital of Piraeus
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Pátrai, Kreikka, 264 43
- Olympion Clinic
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Thessaloniki, Kreikka, 546 39
- Interbalkan Medical Center of Thessaloniki
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Bottrop, Saksa, 46236
- Knappschaft Kliniken Marienhospital Bottrop
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Erlangen, Saksa, 91054
- Universitatsklinikum Erlangen
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Essen, Saksa, 45136
- Kliniken Essen-Mitte
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Heidelberg, Saksa, 69120
- Universitätsklinikum Heidelberg
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Mainz, Saksa, 55101
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
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Singapore, Singapore, 117599
- National University Hospital
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Singapore, Singapore, 258500
- Oncocare Cancer Centre
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Chang-hua, Taiwan, 500
- Changhua Christian Hospital
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Kaohsiung Country, Taiwan, 833
- Chang Gung Memorial Hospital
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Tainan, Taiwan, 70457
- National Cheng Kung University Hospital
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Taipei, Taiwan, 112
- Koo Foundation Sun Yat-Sen Cancer Center
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Taipei, Taiwan, 100229
- National Taiwan University Hospital
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Taipei, Taiwan
- Chang Gung Memorial Hospital - Linkou Branch
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Ankara, Turkki (Türkiye), 06520
- Memorial Ankara Hastanesi
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Sakarya, Turkki (Türkiye), 811
- SAKARYA University Medical Faculty
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Dorchester, Yhdistynyt kuningaskunta, DT1 2JY
- Dorset County Hospital
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London, Yhdistynyt kuningaskunta, N18 1QX
- North Middlesex Uni Hospital
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Nottingham, Yhdistynyt kuningaskunta, NG5 1PB
- Nottingham City Hospital
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Manchester
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Manchester, Manchester, Yhdistynyt kuningaskunta, M20 4BX
- The Christie NHS Foundation Trust - SSC Parent
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Alaska
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Anchorage, Alaska, Yhdysvallat, 99508
- Alaska Oncology & Hematology, LLC
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Arizona
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Tucson, Arizona, Yhdysvallat, 85711
- Arizona Oncology Associates, PC-CASA
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Arkansas
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Little Rock, Arkansas, Yhdysvallat, 72205-7199
- University of Arkansas for Medical Sciences
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California
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Berkeley, California, Yhdysvallat, 94704
- Alta Bates Summit Medical Center
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Beverly Hills, California, Yhdysvallat, 90211
- Beverly Hills Cancer Center
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Cerritos, California, Yhdysvallat, 90703
- TOI Clinical Research
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Fresno, California, Yhdysvallat, 93710
- Women's Cancer Care
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La Jolla, California, Yhdysvallat, 92037
- Scripps Health
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Los Angeles, California, Yhdysvallat, 90017
- Los Angeles Hematology Oncology Medical Group
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Orange, California, Yhdysvallat, 92868
- University of California, Irvine Medical Center
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Connecticut
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New Haven, Connecticut, Yhdysvallat, 06520
- Yale Cancer Center
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Florida
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Miami Beach, Florida, Yhdysvallat, 33140
- Mount Sinai Medical Center
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Orlando, Florida, Yhdysvallat, 32806
- Orlando Health Cancer Institute
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Georgia
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Marietta, Georgia, Yhdysvallat, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Savannah, Georgia, Yhdysvallat, 31405
- Summit Cancer Care PC
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Illinois
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Chicago, Illinois, Yhdysvallat, 60611
- Northwestern University
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Springfield, Illinois, Yhdysvallat, 62702
- Springfield Clinic
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Indiana
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Indianapolis, Indiana, Yhdysvallat, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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Kansas
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Westwood, Kansas, Yhdysvallat, 66205
- University of Kansas Cancer Center
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Maine
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Brewer, Maine, Yhdysvallat, 04412
- Eastern Maine Medical Center
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Scarborough, Maine, Yhdysvallat, 04074
- New England Cancer Specialists
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Maryland
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Annapolis, Maryland, Yhdysvallat, 21401
- Anne Arundel Medical Center
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Baltimore, Maryland, Yhdysvallat, 21202
- Mercy Medical Center
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Baltimore, Maryland, Yhdysvallat, 21201
- University of Maryland Greenebaum Cancer Center
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Dana Farber Cancer Institute
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Minnesota
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Saint Louis Park, Minnesota, Yhdysvallat, 55416
- Metro-Minnesota Community Oncology Research Consortium
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68103
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
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Nevada
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Reno, Nevada, Yhdysvallat, 89502
- Renown Regional Medical Center
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New Jersey
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Basking Ridge, New Jersey, Yhdysvallat, 07920
- Memorial Sloan Kettering - Basking Ridge
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Middletown, New Jersey, Yhdysvallat, 07748
- Memorial Sloan Kettering - Monmouth
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New Mexico
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Farmington, New Mexico, Yhdysvallat, 87401
- San Juan Oncology Associates
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New York
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New York, New York, Yhdysvallat, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Yhdysvallat, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Yhdysvallat, 10011
- The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
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Stony Brook, New York, Yhdysvallat, 11794
- Stony Brook University Medical Center
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Ohio
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Columbus, Ohio, Yhdysvallat, 43219
- SCRI Mark H. Zangmeister Center
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Oklahoma
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Tulsa, Oklahoma, Yhdysvallat, 74146
- Oklahoma Cancer Specialists and Research Institute
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Oregon
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Bend, Oregon, Yhdysvallat, 97701
- St Charles Medical Center Bend
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Abramson Cancer Center
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Pittsburgh, Pennsylvania, Yhdysvallat, 15213
- UPMC Hillman Cancer Center - Magee-Women?s Hospital
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West Chester, Pennsylvania, Yhdysvallat, 19380
- Abramson Cancer Center Chester County Hospital
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West Reading, Pennsylvania, Yhdysvallat, 19611
- McGlinn Cancer Institute at Reading Hospital
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South Dakota
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Sioux Falls, South Dakota, Yhdysvallat, 57105
- Avera Cancer Institute
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Tennessee
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Germantown, Tennessee, Yhdysvallat, 38138
- West Cancer Center
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Texas
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Bedford, Texas, Yhdysvallat, 76022
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Yhdysvallat, 75246
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Denton, Texas, Yhdysvallat, 76201
- Texas Oncology-Denton South
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El Paso, Texas, Yhdysvallat, 79902
- Texas Oncology, P.A. - El Paso
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Houston, Texas, Yhdysvallat, 77030
- Houston Methodist Cancer Center
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Houston, Texas, Yhdysvallat, 77090
- Millennium Research & Clinical Development
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San Antonio, Texas, Yhdysvallat, 78229
- Texas Oncology P.A.
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Virginia
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Fairfax, Virginia, Yhdysvallat, 22031
- Virginia Cancer Specialists
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Fairfax, Virginia, Yhdysvallat, 22031
- Inova Fairfax Hospital
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Norfolk, Virginia, Yhdysvallat, 23502
- Virginia Oncology Associates
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Washington
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Tacoma, Washington, Yhdysvallat, 98405
- Northwest Medical Specialties, PLLC
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
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Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
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Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally
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Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) Estrogen Receptor 1 (ESR1) mutation status determination by central testing
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Prior endocrine therapy (ET) in combination with cyclin-dependent kinase 4/6 inhibitors in either setting as follows:
- Metastatic setting: Disease progression after ≥6 months on ET plus CDK4/6 inhibitor in the locally advanced or metastatic setting. If ET plus CDK4/6 inhibitor is not the most recent therapy, then patient must also have had disease progression after ≥4 months on most recent ET
- Adjuvant Setting: Relapse either while taking or within 12 months of exposure to combination adjuvant ET and CDK4/6 inhibitor. Patients must have taken at least 12 months of adjuvant ET, 6 months of which was in combination with a CDK4/6 inhibitor.
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Measurable disease as defined per RECIST v.1.1 or evaluable bone metastases. Patients with evaluable bone disease in the absence of measurable disease outside of the bone must have at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) which can be followed
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Eastern Cooperative Oncology Group Performance Status 0-1
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For women who are premenopausal or perimenopausal and for men: treatment with approved luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment
Exclusion Criteria:
- Prior treatment with another oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting. Prior fulvestrant is allowed if treatment was terminated at least 28 days prior to randomization. Prior treatment with tamoxifen is allowed.
- Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
- Prior chemotherapy for locally advanced unresectable or metastatic disease
- Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
- Treatment with any investigational therapy within 28 days prior to initiation of study treatment
- Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
- History of any other malignancy other than breast cancer within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer, or other non-breast cancers at very low risk of recurrence
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
- Active cardiac disease or history of cardiac dysfunction
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C including active viral or other hepatitis virus, current alcohol abuse, or cirrhosis
- Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection
- Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
- Serious infection requiring oral or intravenous (IV) antibiotics, or other clinically significant infection, within 14 days prior to randomization
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- Known allergy or hypersensitivity to any of the study drugs or any of their excipients
- For premenopausal or perimenopausal women and for men: known hypersensitivity to LHRH agonists
- Pregnant or breastfeeding
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Giredestrant plus Everolimus
|
Participants will receive treatment with giredestrant 30 milligrams (mg) orally once a day (QD) on Days 1-28 of each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
Muut nimet:
Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms. |
|
Active Comparator: Physician's Choice of Endocrine Therapy plus Everolimus
The physician's choice of endocrine therapy is defined as either exemestane, fulvestrant, or tamoxifen. |
Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms. If exemestane is chosen as the physician's choice of endocrine therapy, the participant will receive exemestane at a dose of 25 mg orally once a day (QD) on Days 1-28 of each 28-day cycle or as per local label, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1. If fulvestrant is chosen as the physician's choice of endocrine therapy, the participant will receive fulvestrant in the clinic at a dose of 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, then Day 1 of each cycle thereafter (1 cycle is 28 days) or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1. If tamoxifen is chosen as the physician's choice of endocrine therapy, the participant will receive tamoxifen at a dose of 20 mg orally QD on Days 1-28 of each 28-day cycle or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)
|
The Intent-to-Treat (ITT) population consists of all randomized participants, and the ESR1m subpopulation is defined as participants in the ITT population whose tumors harbor a detectable Estrogen Receptor 1 (ESR1) mutation at baseline as measured in circulating tumor DNA (ctDNA). |
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Kokonaiseloonjääminen ESR1m:n osapopulaatiossa ja ITT-populaatiossa
Aikaikkuna: Satunnaistamisesta kuolemaan mistä tahansa syystä (enintään 42 kuukautta)
|
Satunnaistamisesta kuolemaan mistä tahansa syystä (enintään 42 kuukautta)
|
|
|
Vastauksen kesto (DOR), jonka tutkija on määrittänyt RECIST v1.1:n mukaisesti ESR1m-alapopulaatiossa ja ITT-populaatiossa
Aikaikkuna: Ensimmäisestä dokumentoidusta objektiivisesta vasteesta taudin etenemiseen tai mistä tahansa syystä johtuvaan kuolemaan sen mukaan, kumpi tapahtuu ensin (enintään 42 kuukautta)
|
Ensimmäisestä dokumentoidusta objektiivisesta vasteesta taudin etenemiseen tai mistä tahansa syystä johtuvaan kuolemaan sen mukaan, kumpi tapahtuu ensin (enintään 42 kuukautta)
|
|
|
Osallistujien määrä, joilla on vähintään yksi haittatapahtuma, jonka vakavuus on määritetty National Cancer Instituten yleisten haitallisten tapahtumien terminologian kriteerien, version 5 (NCI CTCAE v5.0) mukaisesti
Aikaikkuna: Lähtötilanteesta 30 päivään tutkimushoidon viimeisen annoksen jälkeen (jopa 42 kuukautta)
|
Lähtötilanteesta 30 päivään tutkimushoidon viimeisen annoksen jälkeen (jopa 42 kuukautta)
|
|
|
Niiden osallistujien määrä, joilla oli poikkeavuuksia kliinisissä laboratoriotesteissä hematologisissa parametreissa tutkimuksen aikana
Aikaikkuna: Lähtötilanteesta 30 päivään tutkimushoidon viimeisen annoksen jälkeen (jopa 42 kuukautta)
|
Lähtötilanteesta 30 päivään tutkimushoidon viimeisen annoksen jälkeen (jopa 42 kuukautta)
|
|
|
Niiden osallistujien määrä, joilla oli poikkeavuuksia biokemian parametrien kliinisissä laboratoriotesteissä tutkimuksen aikana
Aikaikkuna: Lähtötilanteesta 30 päivään tutkimushoidon viimeisen annoksen jälkeen (jopa 42 kuukautta)
|
Lähtötilanteesta 30 päivään tutkimushoidon viimeisen annoksen jälkeen (jopa 42 kuukautta)
|
|
|
Giredestrantin plasmakonsentraatio määrätyissä aikapisteissä
Aikaikkuna: Ennen annostusta ja 3 tuntia annoksen ottamisen jälkeen syklin 1 päivinä 1 ja 15 ja esiannostuksena syklien 2 ja 3 päivänä 1 (1 jakso on 28 päivää)
|
Ennen annostusta ja 3 tuntia annoksen ottamisen jälkeen syklin 1 päivinä 1 ja 15 ja esiannostuksena syklien 2 ja 3 päivänä 1 (1 jakso on 28 päivää)
|
|
|
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until progressive disease or death (up to 42 months)
|
The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart. |
From randomization until progressive disease or death (up to 42 months)
|
|
Clinical Benefit Rate (CBR), as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From Baseline until progressive disease or death (up to 42 months)
|
The clinical benefit rate is defined as the percentage of participants with stable disease for at least (≥)24 weeks or a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart. |
From Baseline until progressive disease or death (up to 42 months)
|
|
Time to Confirmed Deterioration in Pain Severity, as Determined Using the Brief Pain Inventory Short-Form (BPI-SF) Worst Pain Item Score, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until 90 days after treatment discontinuation (up to 42 months)
|
Time to confirmed deterioration in pain severity is defined as the time from randomization to the first documentation of ≥2-point increase from baseline on the "worst pain" item score (scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine") held for 2 consecutive time points, or a ≥2-point increase followed by death attributable to cancer progression within 28 days from the last assessment. |
From randomization until 90 days after treatment discontinuation (up to 42 months)
|
|
Time to Confirmed Deterioration in Pain Presence and Interference, as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed Pain Scale Score, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until 90 days after treatment discontinuation (up to 42 months)
|
Time to confirmed deterioration in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score held for 2 consecutive time points, or a ≥10-point increase followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 |
From randomization until 90 days after treatment discontinuation (up to 42 months)
|
|
Time to Confirmed Deterioration in Physical Functioning (PF), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed PF Scale Score, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until 90 days after treatment discontinuation (up to 42 months)
|
Time to confirmed deterioration in physical functioning (PF) is defined as the time from randomization to the first documentation of ≥10-point decrease in PF score held for 2 consecutive time points, or a ≥10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 |
From randomization until 90 days after treatment discontinuation (up to 42 months)
|
|
Time to Confirmed Deterioration in Role Functioning (RF), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed RF Scale Score, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until 90 days after treatment discontinuation (up to 42 months)
|
Time to confirmed deterioration in role functioning (RF) is defined as the time from randomization to the first documentation of ≥10-point decrease in RF score held for 2 consecutive time points, or a ≥10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 |
From randomization until 90 days after treatment discontinuation (up to 42 months)
|
|
Time to Confirmed Deterioration in Health-Related Quality of Life (HRQoL), as Determined Using the EORTC QLQ-C30 Questionnaire Linearly Transformed Global Health Status (GHS)/QoL Scale Score, in the ESR1m Subpopulation and ITT Population
Aikaikkuna: From randomization until 90 days after treatment discontinuation (up to 42 months)
|
Time to confirmed deterioration in HRQoL is defined as the time from randomization to the first documentation of ≥10-point decrease in GHS/QoL score held for 2 consecutive time points, or a ≥10-point decrease followed by death attributable to cancer progression within 28 days from the last assessment. EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 |
From randomization until 90 days after treatment discontinuation (up to 42 months)
|
|
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Aikaikkuna: From Baseline until 30 days after the final dose of study treatment (up to 42 months)
|
Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature. |
From Baseline until 30 days after the final dose of study treatment (up to 42 months)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Trials, Genentech, Inc.
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Ihosairaudet
- Rintojen sairaudet
- Iho- ja sidekudostaudit
- Rintojen kasvaimet
- Hormonit
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Aivolisäkkeen vapauttavat hormonit
- Hypotalamuksen hormonit
- Peptidihormonit
- Neuropeptidit
- Peptidit
- Aminohapot, peptidit ja proteiinit
- Oligopeptidit
- Hermokudosproteiinit
- Proteiinit
- Orgaaniset kemikaalit
- Hiilivety
- Hiilivedyt, sykliset
- Hiilivedyt, aromaattiset
- Polisykliset yhdisteet
- Steroidit
- Sulatettu rengasyhdisteet
- Bentseenijohdannaiset
- Makrolidit
- Laktotonit
- Estradioli
- Esreenit
- Estaanit
- Estradioli -yhdistäjät
- Gonadal -steroidihormonit
- Gonadal -hormonit
- Sirolimuusi
- Stilbeenit
- Bentsyylideeniyhdisteet
- Fulvestrantti
- Everolimus
- Tamoksifeeni
- Gonadotropiinia vapauttava hormoni
- geiredestrantti
- exemestane
Muut tutkimustunnusnumerot
- ML43171
- 2022-000199-20 (EudraCT-numero)
- 2023-506821-12-00 (Rekisterin tunniste: CTIS (EU))
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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IPD-suunnitelman kuvaus
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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