En undersøgelse for at evaluere effektiviteten og sikkerheden af Giredestrant i kombination med Phesgo (Pertuzumab, Trastuzumab og Hyaluronidase-zzxf) versus Phesgo hos deltagere med lokalt avanceret eller metastatisk brystkræft (heredERA brystkræft)
30. september 2026 opdateret af: Hoffmann-La Roche
En fase III, randomiseret, åben-label undersøgelse, der evaluerer effektiviteten og sikkerheden af Giredestrant i kombination med Phesgo versus Phesgo efter induktionsterapi med Phesgo + Taxane hos patienter med tidligere ubehandlet HER2-positiv, østrogenreceptor-positiv lokalt avanceret eller metastatisk brystkræft
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
922
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
- Centro Oncologico Korben
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (CORI)
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Mendoza, Argentina, M5500AYB
- Fundacion Centro Oncologico de Integracion Regional (COIR)
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Rosario, Argentina, S2002KDS
- Hospital Provincial del Centenario
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Rosario, Argentina, S2000KZE
- Instituto de Oncología de Rosario
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San Juan, Argentina, J5400DIL
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
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Ciudad Autónoma de BuenosAires
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
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Charleroi, Belgien, 6000
- GHdC Site Les Viviers
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Ghent, Belgien, 9000
- UZ Gent
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Hasselt, Belgien, 3500
- Jessa Zkh (Campus Virga Jesse)
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Leuven, Belgien, 3000
- UZ Leuven Gasthuisberg
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Namur, Belgien, 5000
- Clinique Ste-Elisabeth
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Ceará
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Fortaleza, Ceará, Brasilien, 60810-180
- Pronutrir - suporte nutricional e quimioterapia ltda.
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 41253-190
- Hospital Sao Rafael - HSR
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Goiás
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Goiânia, Goiás, Brasilien, 74605-070
- Hospital Araujo Jorge
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Paraná
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Londrina, Paraná, Brasilien, 86015-520
- Hospital do Câncer de Londrina
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Pernambuco
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Recife, Pernambuco, Brasilien, 50040-000
- Hospital do Cancer de Pernambuco - HCP
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brasilien, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brasilien, 91350-200
- Hospital Nossa Senhora da Conceicao
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Rondônia
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Porto Velho, Rondônia, Brasilien, 76834-899
- Hospital de Amor Amazônia
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São Paulo
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Barretos, São Paulo, Brasilien, 14784-400
- Fundação Pio XII Hospital de Câncer de Barretos
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São Paulo, São Paulo, Brasilien, 01317-001
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
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Barranquilla, Colombia, 080020
- Clinica De La Costa
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Bogota, D.C., Colombia, 110131
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
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Bogotá, Colombia, 111321
- Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
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Montería, Colombia, 230002
- Oncomedica S.A.
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Pereira, Colombia, 600004
- Oncólogos de Occidente
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Bath, Det Forenede Kongerige, BA1 3NG
- Royal United Hospital
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Blackpool, Det Forenede Kongerige, FY3 8NR
- Blackpool Victoria Hospital
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Cleveland, Det Forenede Kongerige, TS19 8PE
- University Hospital North Tees
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London, Det Forenede Kongerige, W6 8RF
- Charing Cross Hospital
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Maidstone, Det Forenede Kongerige, ME16 9QQ
- Maidstone Hospital
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Nottingham, Det Forenede Kongerige, NG5 1PB
- Nottingham University Hospitals NHS Trust - City Hospital
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Preston, Det Forenede Kongerige, PR2 9HT
- Royal Preston Hosp
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Rhyl, Det Forenede Kongerige, LL18 5UJ
- North Wales Cancer Treatment Centre, Glan Clwyd Hospital
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Swansea, Det Forenede Kongerige, SA2 8QA
- Singleton Hospital
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Truro, Det Forenede Kongerige, TR1 3LJ
- Royal Cornwall Hospital
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Cairo, Egypten
- Sohag Oncology Center
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Cairo, Egypten
- Dar El salam Cancer Centre
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Cairo, Egypten
- National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement
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Abu Dhabi, Forenede Arabiske Emirater
- Burjeel Medical City-Abu Dhabi
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Al Ain City, Forenede Arabiske Emirater, 15258
- Tawam Hospital
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Arizona
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Tucson, Arizona, Forenede Stater, 85715
- Arizona Clinical Research Center, Inc
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California
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Los Angeles, California, Forenede Stater, 90017
- Los Angeles Hematology Oncology Medical Group
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Cancer Specialists of North Florida
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Maryland Oncology Hematology - Annapolis
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- West Cancer Center
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Texas Oncology - DFW
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El Paso, Texas, Forenede Stater, 79902
- Texas Oncology - El Paso
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Washington
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Edmonds, Washington, Forenede Stater, 98026
- Swedish Cancer Institute - Edmonds Campus
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Issaquah, Washington, Forenede Stater, 98029
- Swedish Cancer Institute - Issaquah
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Avignon, Frankrig, 84918
- Institut Sainte Catherine
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Bayonne, Frankrig, 64109
- CH de la Côte Basque - Hôpital de Bayonne
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Besançon, Frankrig, 25030
- CHU Besançon - Hôpital Jean Minjoz
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Bordeaux, Frankrig, 33077
- Polyclinique Bordeaux Nord Aquitaine
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Grenoble, Frankrig, 38043
- CHU de GRENOBLE
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La Roche-sur-Yon, Frankrig, 85025
- CHD Vendée
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Lyon, Frankrig, 69373
- Hopital Prive Jean Mermoz
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Paris, Frankrig, 75005
- INSTITUT CURIE_Site Paris
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Perpignan, Frankrig, 66000
- Centre Catalan D' Oncologie
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Karnataka
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Bangalore, Karnataka, Indien, 560017
- Manipal Hospital
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Maharashtra
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Mumbai, Maharashtra, Indien, 400012
- Tata Memorial Hospital
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Pune, Maharashtra, Indien, 411028
- Sahyadri Super Specialty Hospital Hadapsar
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indien, 110085
- Rajiv Gandhi Cancer Inst.&Research Center
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New Delhi, National Capital Territory of Delhi, Indien, 110088
- Fortis Hospital
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West Bengal
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Kolkata, West Bengal, Indien, 700156
- TATA Medical Centre
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Kolkata, West Bengal, Indien, 700094
- Netaji Subhas Chandra Bose Cancer Hospital
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Campania
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Naples, Campania, Italien, 80131
- Azienda Ospedaliera Universitaria Federico II
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Naples, Campania, Italien, 80131
- Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
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Emilia-Romagna
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Reggio Emilia, Emilia-Romagna, Italien, 42123
- Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
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Rimini, Emilia-Romagna, Italien, 47900
- Ospedale Infermi AUSL della Romagna
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Lazio
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Rome, Lazio, Italien, 00168
- Policlinico Universitario Agostino Gemelli
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Lombardy
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Brescia, Lombardy, Italien, 25123
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Italien, 20141
- Istituto Europeo Di Oncologia
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Rozzano, Lombardy, Italien, 20089
- Istituto Clinico Humanitas
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Sicily
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Misterbianco (CT), Sicily, Italien, 95045
- Humanitas Centro Catanese Di Oncologia
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Tuscany
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Livorno, Tuscany, Italien, 57100
- Ospedale Civile
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Veneto
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Padova, Veneto, Italien, 35128
- IOV - Istituto Oncologico Veneto - IRCCS
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Amman, Jordan, 1269
- King Hussein Cancer Center
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Eldoret, Kenya, 30100
- International Cancer Institute (ICI)
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Nairobi, Kenya, 00100
- The Aga Khan University-Kenya.
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Baoding, Kina, 071000
- Affiliated Hospital of Hebei University
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Beijing, Kina, 100044
- Peking University People's Hospital
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Bengbu, Kina, 233000
- the First Affiliated Hospital of Bengbu Medical College
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Changchun, Kina, 130021
- The First Hospital of Jilin University
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Changsha, Kina, 410013
- Hunan Cancer Hospital
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Chengdu, Kina, 610041
- Sichuan Cancer Hospital
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Chengdu, Kina, 610047
- West China Hospital - Sichuan University
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Fuzhou, Kina, 350014
- Fujian Cancer Hospital
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Fuzhou, Kina, 350009
- No. 900 Hospital (Fuzhou General Hospital)
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Hangzhou, Kina, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Kina, 310014
- Zhejiang Provincial People?s Hospital
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Jinan, Kina, 250117
- Shandong Cancer Hospital
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Jinzhou, Kina, 121001
- The First Affiliated Hospital Of Jinzhou Medical University
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Kunming, Kina, 650118
- Yunnan Cancer Hospital
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Nanchang, Kina, 330006
- Jiangxi Cancer Hospital
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Nanjing, Kina, 210009
- Jiangsu Cancer Hospital
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Nanjing, Kina, 210029
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
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Nanning, Kina, 530021
- Guangxi Cancer Hospital of Guangxi Medical University
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Shenyang, Kina, 110001
- The First Affiliated Hospital of China Medical University
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Tianjin, Kina, 300060
- Tianjin Cancer Hospital
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Wuhan, Kina, 430023
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Xi'an, Kina, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Ürümqi, Kina, 830000
- The Tumor Hospital of Xinjiang Medical University
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Beirut, Libanon, 1107 2020
- American University of Beirut - Medical Center
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Beirut, Libanon
- Rizk Hospital
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Chihuahua City, Mexico, 31000
- Centro Estatal de Cancerologia de Chihuahua
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Baja California Sur
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La Paz, Baja California Sur, Mexico, 23040
- Investigacion Oncofarmaceutica
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Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Mexico CITY (federal District)
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D.F., Mexico CITY (federal District), Mexico, 04980
- Iem-Fucam
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Mexico City, Mexico CITY (federal District), Mexico, 03100
- Health Pharma Professional Research
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario
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Monterrey, Nuevo León, Mexico, 64460
- Filios Alta Medicina
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Monterrey, Nuevo León, Mexico
- Hospital Zambrano Hellion TecSalud
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Querétaro
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Querétaro City, Querétaro, Mexico, 76000
- Cuidados oncologicos
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San Luis Potosí
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San Luis Potosí City, San Luis Potosí, Mexico, 78209
- Oncologico Potosino
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Muscat, Oman
- Sultan Qaboos Comprehensive Cancer Care & Research Center
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Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
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Konin, Polen, 62-500
- Przychodnia Lekarska KOMED, Roman Karaszewski
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Koszalin, Polen, 75-581
- Szpital Wojewódzki im. Miko?aja Kopernika
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Opole, Polen, 45-060
- Opolskie Centrum Onkologii
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Pi?a, Polen, 64-920
- Ars Medical Sp. z o. o.
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Późna, Polen, 60-569
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
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Rzeszów, Polen, 35-021
- MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
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Warsaw, Polen, 02-781
- Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
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Coimbra, Portugal, 3000-075
- IPO de Coimbra
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Lisbon, Portugal, 1495-005
- Hospital de S. Francisco Xavier
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Loures, Portugal, 2674-514
- Hospital Beatriz Angelo
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Porto, Portugal, 4200-072
- IPO do Porto
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Riyadh, Saudi Arabien, 11525
- King Fahad Medical City
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Riyadh, Saudi Arabien, 11211
- King Faisal Specialist Hospital & Research Centre
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Riyadh, Saudi Arabien, 11426
- National Guard King Abdulaziz Medical City
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Barcelona, Spanien, 08036
- Hospital Clínic i Provincial
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Granada, Spanien, 18016
- Hospital Universitario Clínico San Cecilio
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Huelva, Spanien, 21005
- Hospital Juan Ramon Jimenez
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Madrid, Spanien, 28033
- Centro Oncologico MD Anderson Internacional
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Málaga, Spanien, 29010
- Hospital Clinico Universitario Virgen de la Victoria
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Valencia, Spanien, 46015
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
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Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
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Barcelona
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Sant Andreu de la Barca, Barcelona, Spanien, 08740
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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LA Coruna
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Santiago de Compostela, LA Coruna, Spanien, 15706
- Complejo Hospitalario Universitario de Santiago (CHUS)
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Tenerife
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San Cristóbal de La Laguna, Tenerife, Spanien, 38320
- Hospital Universitario de Canarias
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Parktown, Johannesburg, Sydafrika, 2193
- Wits Donald Gordon Clinical Trial Centre
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Daegu, Sydkorea, 41404
- Kyungpook National University Chilgok Hospital
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Goyang-si, Sydkorea, 10408
- National Cancer Center
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Seoul, Sydkorea, 05505
- Asan Medical Center
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Seoul, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Sydkorea, 06273
- Gangnam Severance Hospital
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Seoul, Sydkorea, 06591
- Seoul St Mary's Hospital
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Taichung, Taiwan, 404
- China Medical University Hospital
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Tainan, Taiwan, 00704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital Office of General Surgery
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Bangkok, Thailand, 10400
- Rajavithi Hospital
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Bangkok, Thailand, 10400
- Ramathibodi Hospital
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Chiang Mai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Songkhla, Thailand, 90110
- Songklanagarind Hospital
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Adana, Tyrkiet (Türkiye), 01120
- Adana Baskent University Hospital
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Ankara, Tyrkiet (Türkiye), 06500
- Gazi Uni Medical Faculty Hospital
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara City Hospital
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Ankara, Tyrkiet (Türkiye), 06200
- Ankara Oncology Hospital
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Diyarbakır, Tyrkiet (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Tyrkiet (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Erzurum, Tyrkiet (Türkiye), 25240
- Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
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Istanbul, Tyrkiet (Türkiye), 34384
- Prof. Dr. Cemil Tascioglu City Hospital
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Istanbul, Tyrkiet (Türkiye), 34662
- Ac?badem Altunizade Hastanesi
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Izmir, Tyrkiet (Türkiye), 35100
- Ege Uni Medical Faculty
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Izmir, Tyrkiet (Türkiye), 35360
- Izmir Ataturk Training and Research Hospital
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Kayseri, Tyrkiet (Türkiye), 38039
- Erciyes Uni
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Kepez, Tyrkiet (Türkiye), 07020
- Antalya Memorial Hastanesi
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Mersin, Tyrkiet (Türkiye), 33240
- Mersin City Education and Research Hospital
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Samsun, Tyrkiet (Türkiye), 55139
- Ondokuz Mayis Univ. Med. Fac.
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Seyhan, Tyrkiet (Türkiye), 01140
- Medical Park Seyhan Hospital
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Tekirdağ, Tyrkiet (Türkiye), 59030
- Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
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İzmit, Tyrkiet (Türkiye), 31380
- Kocaeli University Faculty of Medicine
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Bad Nauheim, Tyskland, 61231
- Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim
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Bamberg, Tyskland, 96049
- Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
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Essen, Tyskland, 45136
- Kliniken Essen-Mitte
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Freiburg im Breisgau, Tyskland, 79106
- Universitätsklinikum Freiburg
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Heidelberg, Tyskland, 69120
- Nationales Centrum für Tumorerkrankungen (NCT)
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Hildesheim, Tyskland, 31134
- Ärztehaus am Bahnhofsplatz
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Homburg/Saar, Tyskland, 66424
- Universitätsklinikum des Saarlandes
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Langen, Tyskland, 63225
- Dres. Andreas Köhler und Roswitha Fuchs
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Ravensburg, Tyskland, 88212
- MVZ für Hämatologie und Onkologie Ravensburg GmBH
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Regensburg, Tyskland, 93053
- Caritas-Krankenhaus St. Josef
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Trier, Tyskland, 54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH;Gynäkologie
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Tübingen, Tyskland, 72076
- Universitätsklinik Tübingen
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Kampala, Uganda, 88560
- Uganda Cancer Institute
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Budapest, Ungarn, 1032
- Budapesti Szent Margit Korhaz
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Budapest, Ungarn, 1082
- Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
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Gyula, Ungarn, 5700
- Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz
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Kaposvár, Ungarn, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
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Szolnok, Ungarn, 5004
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
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Tatabánya, Ungarn, 2800
- Komarom-Eszergom Varmegyei Szent Borbala Korhaz
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
- At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Left ventricular ejection fraction (LVEF) of at least (≥)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Adequate hematologic and end-organ function
- For women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of Phesgo
- For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo
Maintenance Phase Inclusion Criteria
- Complete a minimum of four cycles to a maximum of eight cycles of induction therapy; the minimum cycles are defined as either: Phesgo injections + 4 docetaxel infusions, or Phesgo injections + 12 paclitaxel infusions
- Achieve a minimum of stable disease (SD) (or Non-complete response [CR]/Non-progressive disease [PD] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
- LVEF of ≥50% at the last assessment during the induction therapy phase
Exclusion Criteria:
- Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
- Prior treatment with a selective estrogen receptor degrader (SERD)
- Previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant setting
- Disease progression within 6 months of receiving adjuvant anti-HER2 therapy (such as trastuzumab, with or without pertuzumab [IV, SC, or fixed-dose combination], or ado-trastuzumab emtansine, or neratinib)
- Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
- History of persistent Grade ≥2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy
- History of exposure to the following cumulative doses of anthracyclines; Doxorubicin >360 mg/m2; Liposomal doxorubicin >500 mg/m2; Epirubucin >720 mg/m2; Mitoxantrone >120 mg/m2; Idarubicin >90 mg/m2.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
- Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of Phesgo (Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of induction therapy).
- Treated with investigational therapy within 28 days prior to initiation of induction therapy
- Treated with localized palliative radiotherapy within 14 days prior to initiation of induction therapy
- Concurrent participation in any other therapeutic clinical trial
- Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies
- Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent)
- Poorly controlled hypertension
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, active liver disease including active viral or other hepatitis virus, autoimmune hepatic disorders, or sclerosing cholangitis, current alcohol abuse, or cirrhosis
- Active cardiac disease or history of cardiac dysfunction
- Major surgical procedure or significant traumatic injury within 14 days prior to enrollment or anticipation of need for major surgery during induction therapy
- Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery
- Concurrent, serious, uncontrolled infections, or known infection with HIV with the following exception: Individuals who are HIV positive are eligible provided they are stable on anti-retroviral therapy for ≥4 weeks, have a CD4 count ≥350 cells/uL, and have an undetectable viral load and no history of AIDS-defining opportunistic infections within 12 months prior to enrollment.
- Serious COVID-19 infection within 14 days prior to enrollment; however, no screening testing for SARS-CoV-2 is required
- Serious infection requiring oral or IV antibiotics within 7 days prior to screening
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in the study
- History of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
- For pre- and perimenopausal women, and men: Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa); Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy that requires gonadal function suppression
- Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm B
- A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism, including deep vein thrombosis, unless the condition is adequately treated and under control
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Induktionsterapi: Phesgo plus taxan-baseret kemoterapi
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Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase [rHuPH20]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W).
Andre navne:
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Docetaxel will be administered at 75 milligrams per metre squared of body surface area (mg/m2) intravenously over 60 (±10) minutes on Day 1 of each cycle for 4 to 8 cycles (a cycle is 21 days); this dose may be escalated to 100 mg/m2 if the initial dose was well tolerated. During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Paclitaxel will be administered at 80 milligrams per metre squared of body surface area (mg/m2) intravenously over a minimum of 1 hour on Days 1, 8, and 15 of each cycle for 4 to 8 cycles (a cycle is 21 days); this weekly regimen is considered as one complete cycle whenever 3 weekly doses are given. |
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Aktiv komparator: Arm A, Vedligeholdelsesterapi: Phesgo
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Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase [rHuPH20]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W).
Andre navne:
A luteinizing hormone-releasing hormone (LHRH) agonist will be administered every 28 days to pre- and peri-menopausal women and all male participants while receiving giredestrant in Arm B. An LHRH agonist may be administered to male participants and pre- and peri-menopausal female participants receiving tamoxifen in Arm A, and should be administered to those receiving an aromatase inhibitor in Arm A. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information. For participants in Arm A, optional endocrine therapy of investigator's choice is allowed based on the standard of care, and it can include an aromatase inhibitor or tamoxifen with or without an LHRH agonist, or gonadal ablation. The decision to include or exclude this option must be made prior to randomization. |
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Eksperimentel: Arm B, Vedligeholdelsesterapi: Giredestrant plus Phesgo
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Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase [rHuPH20]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W).
Andre navne:
A luteinizing hormone-releasing hormone (LHRH) agonist will be administered every 28 days to pre- and peri-menopausal women and all male participants while receiving giredestrant in Arm B. An LHRH agonist may be administered to male participants and pre- and peri-menopausal female participants receiving tamoxifen in Arm A, and should be administered to those receiving an aromatase inhibitor in Arm A. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information. A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Progression-fri overlevelse, som bestemt af efterforskeren ifølge RECIST v1.1
Tidsramme: Fra randomisering til vedligeholdelsesbehandling til den første forekomst af sygdomsprogression eller død af enhver årsag, alt efter hvad der sker først (op til 53 måneder)
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Fra randomisering til vedligeholdelsesbehandling til den første forekomst af sygdomsprogression eller død af enhver årsag, alt efter hvad der sker først (op til 53 måneder)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Samlet overlevelse
Tidsramme: Fra randomisering til vedligeholdelsesbehandling til døden fra enhver årsag (op til 98 måneder)
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Fra randomisering til vedligeholdelsesbehandling til døden fra enhver årsag (op til 98 måneder)
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Responsens varighed, som bestemt af efterforskeren i henhold til RECIST v1.1
Tidsramme: Fra første forekomst af dokumenteret objektiv respons efter randomisering til vedligeholdelsesbehandling til sygdomsprogression eller død af enhver årsag, alt efter hvad der sker først (op til 53 måneder)
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Fra første forekomst af dokumenteret objektiv respons efter randomisering til vedligeholdelsesbehandling til sygdomsprogression eller død af enhver årsag, alt efter hvad der sker først (op til 53 måneder)
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Gennemsnitlig rollefunktionsscore over tid, som vurderet ved hjælp af den europæiske organisation for forskning og behandling af kræftkvalitet i livskore 30 (EORTC QLQ-C30) spørgeskema
Tidsramme: Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Gennemsnitlig ændring fra baseline i den rollefunktionsscore over tid, som vurderet ved hjælp af den europæiske organisation for forskning og behandling af kræftkvalitet i livskore 30 (EORTC QLQ-C30) spørgeskema
Tidsramme: Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Gennemsnitlig fysisk funktionsscore over tid, som vurderet ved hjælp af den europæiske organisation for forskning og behandling af kræftkvalitet i livskore 30 (EORTC QLQ-C30) spørgeskema
Tidsramme: Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Gennemsnitlig ændring fra baseline i den fysiske funktionsscore over tid, som vurderet ved hjælp af den europæiske organisation for forskning og behandling af kræftkvalitet i livskore 30 (EORTC QLQ-C30) spørgeskema
Tidsramme: Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Gennemsnitlig global sundhedsstatus/livskvalitet score over tid, som vurderet ved hjælp af den europæiske organisation for forskning og behandling af kræftkvalitet i Life-Core 30 (EORTC QLQ-C30) spørgeskema
Tidsramme: Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Gennemsnitlig ændring fra baseline i den globale sundhedsstatus/livskvalitet score over tid, som vurderet ved hjælp af den europæiske organisation for forskning og behandling af kræftkvalitet i livskore 30 (EORTC QLQ-C30) spørgeskema
Tidsramme: Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Vedligeholdelsescyklusser 1 (baseline), 3, 6, 9, 12, 15, 18, en gang hver 6. cyklus fra cykler 24 til 90 (1 cyklus er 21 dage), behandling af behandlingen, hver 6. måned og hvert år for opfølgningsår Henholdsvis 1-2 og 3-5 (op til 8 år)
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Antal deltagere med mindst en bivirkning, med alvorlighed bestemt i henhold til National Cancer Institute Common Terminology -kriterier for bivirkninger, version 5 (NCI CTCAE v5.0)
Tidsramme: Fra baseline indtil 28 dage efter den endelige dosis af studiebehandling (op til 8 år, 5 måneder)
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Fra baseline indtil 28 dage efter den endelige dosis af studiebehandling (op til 8 år, 5 måneder)
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Antal deltagere med abnormiteter i kliniske laboratorietestresultater
Tidsramme: Fra baseline indtil 28 dage efter den endelige dosis af studiebehandling (op til 8 år, 5 måneder)
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Fra baseline indtil 28 dage efter den endelige dosis af studiebehandling (op til 8 år, 5 måneder)
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Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
Tidsramme: From randomization for maintenance therapy to disease progression or death (up to 53 months)
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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 for maintenance therapy to disease progression or death (up to 53 months)
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Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Tidsramme: From randomization for maintenance therapy to disease progression or death (up to 53 months)
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The clinical benefit rate is defined as the percentage of participants with stable disease or non-CR/non-progressive disease (PD) for ≥24 weeks or a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart. |
From randomization for maintenance therapy to disease progression or death (up to 53 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. juli 2022
Primær færdiggørelse (Anslået)
15. juni 2028
Studieafslutning (Anslået)
31. december 2030
Datoer for studieregistrering
Først indsendt
23. marts 2022
Først indsendt, der opfyldte QC-kriterier
23. marts 2022
Først opslået (Faktiske)
25. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Hudsygdomme
- Brystsygdomme
- Hud- og bindevævssygdomme
- Brystneoplasmer
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Hypofysehormon-frigivende hormoner
- Hypothalamiske hormoner
- Peptidhormoner
- Neuropeptider
- Peptider
- Aminosyrer, peptider og proteiner
- Oligopeptider
- Nervevævsproteiner
- Proteiner
- Organiske kemikalier
- Terapeutik
- Lægemiddeladministrationsruter
- Lægemiddelterapi
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Taxoider
- Cyclodecanes
- Diterpenes
- Injektioner
- Docetaxel
- Trastuzumab
- Paclitaxel
- Gonadotropin-frigivende hormon
- Girestrant
- Pertuzumab
- Injektioner, subkutan
Andre undersøgelses-id-numre
- WO43571
- 2022-500014-26-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .