一项评估 Giredestrant 联合 Phesgo（帕妥珠单抗、曲妥珠单抗和透明质酸酶-zzxf）与 Phesgo 在局部晚期或转移性乳腺癌（heredERA 乳腺癌）参与者中的疗效和安全性的研究
2026年9月30日 更新者：Hoffmann-La Roche
一项 III 期、随机、开放标签研究，评估 Giredestrant 联合 Phesgo 与 Phesgo 联合使用 Phesgo + 紫杉烷对先前未治疗的 HER2 阳性、雌激素受体阳性局部晚期或转移性乳腺癌患者进行诱导治疗后的疗效和安全性
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.
研究概览
地位
主动，不招人
条件
研究类型
介入性
注册 (估计的)
922
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Baoding、中国、071000
- Affiliated Hospital of Hebei University
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Beijing、中国、100044
- Peking University People's Hospital
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Bengbu、中国、233000
- the First Affiliated Hospital of Bengbu Medical College
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Changchun、中国、130021
- The First Hospital of Jilin University
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Changsha、中国、410013
- Hunan Cancer Hospital
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Chengdu、中国、610041
- Sichuan Cancer Hospital
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Chengdu、中国、610047
- West China Hospital - Sichuan University
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Fuzhou、中国、350014
- Fujian Cancer Hospital
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Fuzhou、中国、350009
- No. 900 Hospital (Fuzhou General Hospital)
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Hangzhou、中国、310022
- Zhejiang Cancer Hospital
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Hangzhou、中国、310014
- Zhejiang Provincial People?s Hospital
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Jinan、中国、250117
- Shandong Cancer Hospital
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Jinzhou、中国、121001
- The First Affiliated Hospital Of Jinzhou Medical University
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Kunming、中国、650118
- Yunnan Cancer Hospital
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Nanchang、中国、330006
- Jiangxi Cancer Hospital
-
Nanjing、中国、210009
- Jiangsu Cancer Hospital
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Nanjing、中国、210029
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
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Nanning、中国、530021
- Guangxi Cancer Hospital of Guangxi Medical University
-
Shenyang、中国、110001
- The First Affiliated Hospital of China Medical University
-
Tianjin、中国、300060
- Tianjin Cancer Hospital
-
Wuhan、中国、430023
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Xi'an、中国、710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Ürümqi、中国、830000
- The Tumor Hospital of Xinjiang Medical University
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-
-
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Kampala、乌干达、88560
- Uganda Cancer Institute
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-
-
-
-
Budapest、匈牙利、1032
- Budapesti Szent Margit Korhaz
-
Budapest、匈牙利、1082
- Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
-
Gyula、匈牙利、5700
- Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz
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Kaposvár、匈牙利、7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Szolnok、匈牙利、5004
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
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Tatabánya、匈牙利、2800
- Komarom-Eszergom Varmegyei Szent Borbala Korhaz
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-
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Parktown, Johannesburg、南非、2193
- Wits Donald Gordon Clinical Trial Centre
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-
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Karnataka
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Bangalore、Karnataka、印度、560017
- Manipal Hospital
-
-
Maharashtra
-
Mumbai、Maharashtra、印度、400012
- Tata Memorial Hospital
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Pune、Maharashtra、印度、411028
- Sahyadri Super Specialty Hospital Hadapsar
-
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National Capital Territory of Delhi
-
New Delhi、National Capital Territory of Delhi、印度、110085
- Rajiv Gandhi Cancer Inst.&Research Center
-
New Delhi、National Capital Territory of Delhi、印度、110088
- Fortis Hospital
-
-
West Bengal
-
Kolkata、West Bengal、印度、700156
- TATA Medical Centre
-
Kolkata、West Bengal、印度、700094
- Netaji Subhas Chandra Bose Cancer Hospital
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-
-
-
-
Changhua、台湾、500
- Changhua Christian Hospital
-
Taichung、台湾、404
- China Medical University Hospital
-
Tainan、台湾、00704
- National Cheng Kung University Hospital
-
Taipei、台湾、100
- National Taiwan University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital Office of General Surgery
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-
-
-
-
Barranquilla、哥伦比亚、080020
- Clinica De La Costa
-
Bogota, D.C.、哥伦比亚、110131
- Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
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Bogotá、哥伦比亚、111321
- Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
-
Montería、哥伦比亚、230002
- Oncomedica S.A.
-
Pereira、哥伦比亚、600004
- Oncólogos de Occidente
-
-
-
-
-
Adana、土耳其（türkiye）、01120
- Adana Baskent University Hospital
-
Ankara、土耳其（türkiye）、06500
- Gazi Uni Medical Faculty Hospital
-
Ankara、土耳其（türkiye）、06800
- Ankara City Hospital
-
Ankara、土耳其（türkiye）、06200
- Ankara Oncology Hospital
-
Diyarbakır、土耳其（türkiye）、21280
- Dicle University Faculty of Medicine
-
Edirne、土耳其（türkiye）、22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
-
Erzurum、土耳其（türkiye）、25240
- Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
-
Istanbul、土耳其（türkiye）、34384
- Prof. Dr. Cemil Tascioglu City Hospital
-
Istanbul、土耳其（türkiye）、34662
- Ac?badem Altunizade Hastanesi
-
Izmir、土耳其（türkiye）、35100
- Ege Uni Medical Faculty
-
Izmir、土耳其（türkiye）、35360
- Izmir Ataturk Training and Research Hospital
-
Kayseri、土耳其（türkiye）、38039
- Erciyes Uni
-
Kepez、土耳其（türkiye）、07020
- Antalya Memorial Hastanesi
-
Mersin、土耳其（türkiye）、33240
- Mersin City Education and Research Hospital
-
Samsun、土耳其（türkiye）、55139
- Ondokuz Mayis Univ. Med. Fac.
-
Seyhan、土耳其（türkiye）、01140
- Medical Park Seyhan Hospital
-
Tekirdağ、土耳其（türkiye）、59030
- Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
-
İzmit、土耳其（türkiye）、31380
- Kocaeli University Faculty of Medicine
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-
-
-
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Cairo、埃及
- Sohag Oncology Center
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Cairo、埃及
- Dar El salam Cancer Centre
-
Cairo、埃及
- National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement
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-
-
-
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Chihuahua City、墨西哥、31000
- Centro Estatal de Cancerologia de Chihuahua
-
-
Baja California Sur
-
La Paz、Baja California Sur、墨西哥、23040
- Investigacion Oncofarmaceutica
-
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Jalisco
-
Guadalajara、Jalisco、墨西哥、44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Mexico CITY (federal District)
-
D.F.、Mexico CITY (federal District)、墨西哥、04980
- Iem-Fucam
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Mexico City、Mexico CITY (federal District)、墨西哥、03100
- Health Pharma Professional Research
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Nuevo León
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Monterrey、Nuevo León、墨西哥、64460
- Hospital Universitario
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Monterrey、Nuevo León、墨西哥、64460
- Filios Alta Medicina
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Monterrey、Nuevo León、墨西哥
- Hospital Zambrano Hellion TecSalud
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Querétaro
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Querétaro City、Querétaro、墨西哥、76000
- Cuidados oncologicos
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San Luis Potosí
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San Luis Potosí City、San Luis Potosí、墨西哥、78209
- Oncologico Potosino
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Ceará
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Fortaleza、Ceará、巴西、60810-180
- Pronutrir - suporte nutricional e quimioterapia ltda.
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Estado de Bahia
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Salvador、Estado de Bahia、巴西、41253-190
- Hospital Sao Rafael - HSR
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Goiás
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Goiânia、Goiás、巴西、74605-070
- Hospital Araujo Jorge
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Paraná
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Londrina、Paraná、巴西、86015-520
- Hospital do Câncer de Londrina
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Pernambuco
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Recife、Pernambuco、巴西、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、巴西、98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre、Rio Grande do Sul、巴西、91350-200
- Hospital Nossa Senhora da Conceicao
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Rondônia
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Porto Velho、Rondônia、巴西、76834-899
- Hospital de Amor Amazônia
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São Paulo
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Barretos、São Paulo、巴西、14784-400
- Fundação Pio XII Hospital de Câncer de Barretos
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São Paulo、São Paulo、巴西、01317-001
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
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Bad Nauheim、德国、61231
- Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim
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Bamberg、德国、96049
- Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
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Essen、德国、45136
- Kliniken Essen-Mitte
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Freiburg im Breisgau、德国、79106
- Universitätsklinikum Freiburg
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Heidelberg、德国、69120
- Nationales Centrum für Tumorerkrankungen (NCT)
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Hildesheim、德国、31134
- Ärztehaus am Bahnhofsplatz
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Homburg/Saar、德国、66424
- Universitätsklinikum des Saarlandes
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Langen、德国、63225
- Dres. Andreas Köhler und Roswitha Fuchs
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Ravensburg、德国、88212
- MVZ für Hämatologie und Onkologie Ravensburg GmBH
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Regensburg、德国、93053
- Caritas-Krankenhaus St. Josef
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Trier、德国、54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH;Gynäkologie
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Tübingen、德国、72076
- Universitätsklinik Tübingen
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Campania
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Naples、Campania、意大利、80131
- Azienda Ospedaliera Universitaria Federico II
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Naples、Campania、意大利、80131
- Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
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Emilia-Romagna
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Reggio Emilia、Emilia-Romagna、意大利、42123
- Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
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Rimini、Emilia-Romagna、意大利、47900
- Ospedale Infermi AUSL della Romagna
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Lazio
-
Rome、Lazio、意大利、00168
- Policlinico Universitario Agostino Gemelli
-
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Lombardy
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Brescia、Lombardy、意大利、25123
- Asst Degli Spedali Civili Di Brescia
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Milan、Lombardy、意大利、20141
- Istituto Europeo Di Oncologia
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Rozzano、Lombardy、意大利、20089
- Istituto Clinico Humanitas
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Sicily
-
Misterbianco (CT)、Sicily、意大利、95045
- Humanitas Centro Catanese Di Oncologia
-
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Tuscany
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Livorno、Tuscany、意大利、57100
- Ospedale Civile
-
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Veneto
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Padova、Veneto、意大利、35128
- IOV - Istituto Oncologico Veneto - IRCCS
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Charleroi、比利时、6000
- GHdC Site Les Viviers
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Ghent、比利时、9000
- UZ Gent
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Hasselt、比利时、3500
- Jessa Zkh (Campus Virga Jesse)
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Leuven、比利时、3000
- UZ Leuven Gasthuisberg
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Namur、比利时、5000
- Clinique Ste-Elisabeth
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-
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Riyadh、沙特阿拉伯、11525
- King Fahad Medical City
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Riyadh、沙特阿拉伯、11211
- King Faisal Specialist Hospital & Research Centre
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Riyadh、沙特阿拉伯、11426
- National Guard King Abdulaziz Medical City
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Avignon、法国、84918
- Institut Sainte Catherine
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Bayonne、法国、64109
- CH de la Côte Basque - Hôpital de Bayonne
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Besançon、法国、25030
- CHU Besançon - Hôpital Jean Minjoz
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Bordeaux、法国、33077
- Polyclinique Bordeaux Nord Aquitaine
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Grenoble、法国、38043
- CHU de GRENOBLE
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La Roche-sur-Yon、法国、85025
- CHD Vendée
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Lyon、法国、69373
- Hopital Prive Jean Mermoz
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Paris、法国、75005
- INSTITUT CURIE_Site Paris
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Perpignan、法国、66000
- Centre Catalan D' Oncologie
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Gdansk、波兰、80-214
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
-
Konin、波兰、62-500
- Przychodnia Lekarska KOMED, Roman Karaszewski
-
Koszalin、波兰、75-581
- Szpital Wojewódzki im. Miko?aja Kopernika
-
Opole、波兰、45-060
- Opolskie Centrum Onkologii
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Pi?a、波兰、64-920
- Ars Medical Sp. z o. o.
-
Późna、波兰、60-569
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
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Rzeszów、波兰、35-021
- MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
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Warsaw、波兰、02-781
- Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
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-
-
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Bangkok、泰国、10400
- Rajavithi Hospital
-
Bangkok、泰国、10400
- Ramathibodi Hospital
-
Chiang Mai、泰国、50200
- Maharaj Nakorn Chiang Mai Hospital
-
Songkhla、泰国、90110
- Songklanagarind Hospital
-
-
-
-
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Amman、约旦、1269
- King Hussein Cancer Center
-
-
-
-
Arizona
-
Tucson、Arizona、美国、85715
- Arizona Clinical Research Center, Inc
-
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California
-
Los Angeles、California、美国、90017
- Los Angeles Hematology Oncology Medical Group
-
-
Florida
-
Jacksonville、Florida、美国、32256
- Cancer Specialists of North Florida
-
-
Maryland
-
Annapolis、Maryland、美国、21401
- Maryland Oncology Hematology - Annapolis
-
-
Tennessee
-
Germantown、Tennessee、美国、38138
- West Cancer Center
-
-
Texas
-
Dallas、Texas、美国、75246
- Texas Oncology - DFW
-
El Paso、Texas、美国、79902
- Texas Oncology - El Paso
-
-
Washington
-
Edmonds、Washington、美国、98026
- Swedish Cancer Institute - Edmonds Campus
-
Issaquah、Washington、美国、98029
- Swedish Cancer Institute - Issaquah
-
Seattle、Washington、美国、98104
- Swedish Cancer Institute
-
-
-
-
-
Eldoret、肯尼亚、30100
- International Cancer Institute (ICI)
-
Nairobi、肯尼亚、00100
- The Aga Khan University-Kenya.
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-
-
-
-
Bath、英国、BA1 3NG
- Royal United Hospital
-
Blackpool、英国、FY3 8NR
- Blackpool Victoria Hospital
-
Cleveland、英国、TS19 8PE
- University Hospital North Tees
-
London、英国、W6 8RF
- Charing Cross Hospital
-
Maidstone、英国、ME16 9QQ
- Maidstone Hospital
-
Nottingham、英国、NG5 1PB
- Nottingham University Hospitals NHS Trust - City Hospital
-
Preston、英国、PR2 9HT
- Royal Preston Hosp
-
Rhyl、英国、LL18 5UJ
- North Wales Cancer Treatment Centre, Glan Clwyd Hospital
-
Swansea、英国、SA2 8QA
- Singleton Hospital
-
Truro、英国、TR1 3LJ
- Royal Cornwall Hospital
-
-
-
-
-
Coimbra、葡萄牙、3000-075
- IPO de Coimbra
-
Lisbon、葡萄牙、1495-005
- Hospital de S. Francisco Xavier
-
Loures、葡萄牙、2674-514
- Hospital Beatriz Angelo
-
Porto、葡萄牙、4200-072
- IPO do Porto
-
-
-
-
-
Barcelona、西班牙、08036
- Hospital Clínic i Provincial
-
Granada、西班牙、18016
- Hospital Universitario Clínico San Cecilio
-
Huelva、西班牙、21005
- Hospital Juan Ramon Jimenez
-
Madrid、西班牙、28046
- Hospital Universitario La Paz
-
Madrid、西班牙、28033
- Centro Oncologico MD Anderson Internacional
-
Málaga、西班牙、29010
- Hospital Clinico Universitario Virgen de la Victoria
-
Valencia、西班牙、46015
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
-
Zaragoza、西班牙、50009
- Hospital Universitario Miguel Servet
-
-
Barcelona
-
Sant Andreu de la Barca、Barcelona、西班牙、08740
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
-
-
LA Coruna
-
Santiago de Compostela、LA Coruna、西班牙、15706
- Complejo Hospitalario Universitario de Santiago (CHUS)
-
-
Tenerife
-
San Cristóbal de La Laguna、Tenerife、西班牙、38320
- Hospital Universitario de Canarias
-
-
-
-
-
Abu Dhabi、阿拉伯联合酋长国
- Burjeel Medical City-Abu Dhabi
-
Al Ain City、阿拉伯联合酋长国、15258
- Tawam Hospital
-
-
-
-
-
Muscat、阿曼
- Sultan Qaboos Comprehensive Cancer Care & Research Center
-
-
-
-
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Ciudad Autonoma Buenos Aires、阿根廷、C1426AGE
- Centro Oncologico Korben
-
La Rioja、阿根廷、F5300COE
- Centro Oncologico Riojano Integral (CORI)
-
Mendoza、阿根廷、M5500AYB
- Fundacion Centro Oncologico de Integracion Regional (COIR)
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Rosario、阿根廷、S2002KDS
- Hospital Provincial del Centenario
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Rosario、阿根廷、S2000KZE
- Instituto de Oncología de Rosario
-
San Juan、阿根廷、J5400DIL
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
-
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Ciudad Autónoma de BuenosAires
-
Buenos Aires、Ciudad Autónoma de BuenosAires、阿根廷、C1113AAE
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L
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-
-
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Daegu、韩国、41404
- Kyungpook National University Chilgok Hospital
-
Goyang-si、韩国、10408
- National Cancer Center
-
Seoul、韩国、05505
- Asan Medical Center
-
Seoul、韩国、06351
- Samsung Medical Center
-
Seoul、韩国、03722
- Severance Hospital, Yonsei University Health System
-
Seoul、韩国、06273
- Gangnam Severance Hospital
-
Seoul、韩国、06591
- Seoul St Mary's Hospital
-
-
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-
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Beirut、黎巴嫩、1107 2020
- American University of Beirut - Medical Center
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Beirut、黎巴嫩
- Rizk Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：诱导疗法：Phesgo 加紫杉烷类化疗
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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).
其他名称：
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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有源比较器：A 组，维持治疗：Phesgo
|
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).
其他名称：
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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实验性的：B 组，维持治疗：Giredestrant 加 Phesgo
|
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).
其他名称：
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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根据研究者根据RECIST v1.1确定的无进展生存率
大体时间：从维持治疗的随机分组到任何原因的首次出现疾病进展或死亡，以先到者（长达53个月）
|
从维持治疗的随机分组到任何原因的首次出现疾病进展或死亡，以先到者（长达53个月）
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
总体生存
大体时间：从维持治疗的随机分组到任何原因的死亡（最多98个月）
|
从维持治疗的随机分组到任何原因的死亡（最多98个月）
|
|
|
响应持续时间由研究人员根据recist v1.1确定
大体时间：从随机进行维持治疗后首次出现有记录的客观反应到任何原因的疾病进展或死亡（最多53个月）
|
从随机进行维持治疗后首次出现有记录的客观反应到任何原因的疾病进展或死亡（最多53个月）
|
|
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随着时间的流逝，平均角色功能得分，使用欧洲研究和治疗生命核心30（EORTC QLQ-C30）问卷的欧洲组织评估
大体时间：维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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通过欧洲研究和治疗生命核心30（EORTC QLQ-C30）调查表的欧洲研究和治疗欧洲组织评估，从基线的平均变化从基线开始运作。
大体时间：维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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随着时间的流逝，平均身体功能评分，使用欧洲研究和治疗生命核心30（EORTC QLQ-C30）问卷的欧洲组织评估
大体时间：维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
|
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随着时间的推移，从基线的平均变化随着时间的流逝，使用欧洲研究和治疗癌症质量核心30（EORTC QLQ-C30）问卷的欧洲组织进行了评估
大体时间：维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
|
维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
|
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随着时间的推移，全球健康状况/生活质量得分随时间的评分，使用欧洲研究和治疗癌症生命核心质量30（EORTC QLQ-C30）问卷进行评估
大体时间：维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
|
维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
|
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随着时间的推移，全球健康状况/生活质量评分的平均变化，使用欧洲研究和治疗癌症质量核心30（EORTC QLQ-C30）调查表进行评估
大体时间：维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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维护周期1（基线），3、6、9、12、15、18，每6个循环从24循环到90周期（1个周期为21天），治疗中断，每6个月，每年每年进行随访年分别为1-2和3-5（最多8年）
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至少有一个不良事件的参与者数量，根据国家癌症研究所的常见术语标准，对不良事件的常见术语确定，第5版（NCI CTCAE v5.0）
大体时间：从基线到最后剂量的研究治疗后28天（长达8年5个月）
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从基线到最后剂量的研究治疗后28天（长达8年5个月）
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临床实验室测试结果异常的参与者人数
大体时间：从基线到最后剂量的研究治疗后28天（长达8年5个月）
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从基线到最后剂量的研究治疗后28天（长达8年5个月）
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Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
大体时间：From randomization for maintenance therapy to disease progression or death (up to 53 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 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
大体时间：From randomization for maintenance therapy to disease progression or death (up to 53 months)
|
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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Trials、Hoffmann-La Roche
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年7月18日
初级完成 (估计的)
2028年6月15日
研究完成 (估计的)
2030年12月31日
研究注册日期
首次提交
2022年3月23日
首先提交符合 QC 标准的
2022年3月23日
首次发布 (实际的)
2022年3月25日
研究记录更新
最后更新发布 (实际的)
2026年10月2日
上次提交的符合 QC 标准的更新
2026年9月30日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- WO43571
- 2022-500014-26-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.