922
Participants
Start Date
July 18, 2022
Primary Completion Date
October 31, 2027
Study Completion Date
December 31, 2030
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).
Giredestrant
A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle.
Docetaxel
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.
Paclitaxel
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.
LHRH Agonist
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.
Optional Endocrine Therapy of Investigator's Choice
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.
Rizk Hospital, Beirut
National Taiwan University Hospital, Taipei
China Medical University Hospital, Taichung
Changhua Christian Hospital, Changhua
Budapesti Szent Margit Korhaz, Budapest
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika), Budapest
King Hussein Cancer Center, Amman
Wits Donald Gordon Clinical Trial Centre, Parktown, Johannesburg
Komarom-Eszergom Varmegyei Szent Borbala Korhaz, Tatabánya
UZ Leuven Gasthuisberg, Leuven
Jessa Zkh (Campus Virga Jesse), Hasselt
Clinique Ste-Elisabeth, Namur
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok
Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz, Gyula
GHdC Site Les Viviers, Charleroi
Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvár
UZ Gent, Ghent
Rajavithi Hospital, Bangkok
Ramathibodi Hospital, Bangkok
National Cancer Center, Goyang-si
King Faisal Specialist Hospital & Research Centre, Riyadh
Taipei Veterans General Hospital Office of General Surgery, Taipei
National Guard King Abdulaziz Medical City, Riyadh
Queens Hospital Cancer Center, Jamaica
King Fahad Medical City, Riyadh
Clinical Research Alliance, Westbury
Tawam Hospital, Al Ain City
Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela
Hospital Universitario Clínico San Cecilio, Granada
Istituto Clinico Humanitas, Rozzano
Istituto Europeo Di Oncologia, Milan
Hospital Juan Ramon Jimenez, Huelva
Dicle University Faculty of Medicine, Diyarbakır
Maryland Oncology Hematology - Annapolis, Annapolis
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne
Investigacion Oncofarmaceutica, La Paz
CHU Besançon - Hôpital Jean Minjoz, Besançon
Asst Degli Spedali Civili Di Brescia, Brescia
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department, Erzurum
Centro Oncologico MD Anderson Internacional, Madrid
Hospital Universitario La Paz, Madrid
Hospital Clinico Universitario Virgen de la Victoria, Málaga
International Cancer Institute (ICI), Eldoret
Centro Estatal de Cancerologia de Chihuahua, Chihuahua City
Ärztehaus am Bahnhofsplatz, Hildesheim
Kocaeli University Faculty of Medicine, İzmit
Cancer Specialists of North Florida, Jacksonville
Polyclinique Bordeaux Nord Aquitaine, Bordeaux
Mersin City Education and Research Hospital, Mersin
Prof. Dr. Cemil Tascioglu City Hospital, Istanbul
Ac?badem Altunizade Hastanesi, Istanbul
Ege Uni Medical Faculty, Izmir
IOV - Istituto Oncologico Veneto - IRCCS, Padua
Katip Celebi University Ataturk Training and Research Hospital, Izmir
Erciyes Uni, Kayseri
CHU de GRENOBLE, Grenoble
West Cancer Center, Germantown
Hospital Universitario de Canarias, San Cristóbal de La Laguna
Kyungpook National University Chilgok Hospital, Daegu
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS, Reggio Emilia
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara
Kliniken Essen-Mitte, Essen
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia, Valencia
Ospedale Infermi AUSL della Romagna, Rimini
St. Joseph Mercy Hospital, Ann Arbor
Henry Ford Hospital, Detroit
St. Joseph Mercy Oakland, Pontiac
Hospital Universitario Miguel Servet, Zaragoza
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai
Gynäkologisches Zentrum Bonn, Bonn
Klinikum Mutterhaus der Borromaeerinnen gGmbH, Trier
Ondokuz Mayis Univ. Med. Fac., Samsun
Ospedale Civile, Livorno
Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100, Tekirdağ
Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim, Bad Nauheim
Carle Cancer Center, Urbana
Dres. Andreas Köhler und Roswitha Fuchs, Langen
CH de la Côte Basque - Hôpital de Bayonne, Bayonne
Filios Alta Medicina, Monterrey
Hospital Universitario, Monterrey
Centre Catalan D' Oncologie, Perpignan
Universitätsklinikum des Saarlandes, Homburg/Saar
Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg
Hopital Prive Jean Mermoz, Lyon
Universitätsklinik Tübingen, Tübingen
INSTITUT CURIE_Site Paris, Paris
Texas Oncology - DFW, Dallas
CHRISTUS St. Michael Health System, Texarkana
Cuidados oncologicos, Querétaro City
Oncologico Potosino, San Luis Potosí City
CHRISTUS Spohn Cancer Center - Shoreline, Corpus Christi
Universitätsklinikum Freiburg, Freiburg im Breisgau
Texas Oncology - El Paso, El Paso
Azienda Ospedaliera Universitaria Federico II, Napoli
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE, Napoli
Institut Sainte Catherine, Avignon
CHD Vendée, La Roche-sur-Yon
Arizona Clinical Research Center, Inc, Tucson
MVZ für Hämatologie und Onkologie Ravensburg GmBH, Ravensburg
Uganda Cancer Institute, Kampala
Los Angeles Hematology Oncology Medical Group, Los Angeles
Songklanagarind Hospital, Songkhla
Caritas-Krankenhaus St. Josef, Regensburg
Humanitas Centro Catanese Di Oncologia, Misterbianco (CT)
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie, Bamberg
Swedish Cancer Institute - Edmonds Campus, Edmonds
Swedish Cancer Institute - Issaquah, Issaquah
Swedish Cancer Institute, Seattle
Peking University People's Hospital, Beijing
The First Affiliated Hospital of China Medical University, Shenyang
Rajiv Gandhi Cancer Inst.&Research Center, New Delhi
Fortis Hospital, New Delhi
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Bogota, D.C.
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia, Bogotá
The First Affiliated Hospital Of Jinzhou Medical University, Jinzhou
The First Hospital of Jilin University, Changchun
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing
Jiangsu Cancer Hospital, Nanjing
Oncomedica S.A., Montería
the First Affiliated Hospital of Bengbu Medical College, Bengbu
Shandong Cancer Hospital, Jinan
Tianjin Cancer Hospital, Tianjin
Zhejiang Provincial People?s Hospital, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
Jiangxi Cancer Hospital, Nanchang
No. 900 Hospital (Fuzhou General Hospital), Fuzhou
Fujian Cancer Hospital, Fuzhou
Tata Memorial Hospital, Mumbai
Hunan Cancer Hospital, Changsha
Sahyadri Super Specialty Hospital Hadapsar, Pune
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
Guangxi Cancer Hospital of Guangxi Medical University, Nanning
Manipal Hospital, Bangalore
Oncólogos de Occidente, Pereira
Sichuan Cancer Hospital, Chengdu
West China Hospital - Sichuan University, Chengdu
Yunnan Cancer Hospital, Kunming
Netaji Subhas Chandra Bose Cancer Hospital, Kolkata
TATA Medical Centre, Kolkata
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an
The Tumor Hospital of Xinjiang Medical University, Ürümqi
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires
Centro Oncologico Riojano Integral (CORI), La Rioja
Fundacion Centro Oncologico de Integracion Regional (COIR), Mendoza
Instituto de Oncología de Rosario, Rosario
Hospital Provincial del Centenario, Rosario
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan
Pronutrir - suporte nutricional e quimioterapia ltda., Fortaleza
Hospital Sao Rafael - HSR, Salvador
Hospital Araujo Jorge, Goiânia
Hospital do Câncer de Londrina, Londrina
Hospital do Cancer de Pernambuco - HCP, Recife
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí
Hospital Nossa Senhora da Conceicao, Porto Alegre
Hospital de Amor Amazônia, Porto Velho
Fundação Pio XII Hospital de Câncer de Barretos, Barretos
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo
Affiliated Hospital of Hebei University, Baoding
Dar El salam Cancer Centre, Cairo
National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement, Cairo
Sohag Oncology Center, Cairo
Hospital Zambrano Hellion TecSalud, Monterrey
Sultan Qaboos Comprehensive Cancer Care & Research Center, Muscat
Burjeel Medical City-Abu Dhabi, Abu Dhabi
Onkozentrum Dres. Göhler, Dresden
Policlinico Universitario Agostino Gemelli, Rome
Aga Khan University Hospital, Nairobi
American University of Beirut - Medical Center, Beirut
Hotel Dieu de France, Beirut
Iem-Fucam, D.F.
Health Pharma Professional Research, Mexico City
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk
Przychodnia Lekarska KOMED, Roman Karaszewski, Konin
Szpital Wojewódzki im. Miko?aja Kopernika, Koszalin
Opolskie Centrum Onkologii, Opole
Ars Medical Sp. z o. o., Pi?a
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu, Późna
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie, Rzeszów
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii, Warsaw
IPO de Coimbra, Coimbra
Hospital de S. Francisco Xavier, Lisbon
Hospital Beatriz Angelo, Loures
IPO do Porto, Porto
Severance Hospital, Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Gangnam Severance Hospital, Seoul
Samsung Medical Center, Seoul
Seoul St Mary's Hospital, Seoul
Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Sant Andreu de la Barca
Hospital Clínic i Provincial, Barcelona
National Cheng Kung University Hospital, Tainan City
Adana Baskent University Hospital, Adana
Ankara Oncology Hospital, Ankara
Gazi Uni Medical Faculty Hospital, Ankara
Ankara City Hospital, Ankara
Antalya Memorial Hastanesi, Kepez
Medical Park Seyhan Hospital, Seyhan
Ysbyty Gwynedd Hospital, Bangor
Royal United Hospital, Bath
Blackpool Victoria Hospital, Blackpool
University Hospital North Tees, Cleveland
Charing Cross Hospital, London
Maidstone Hospital, Maidstone
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham
Royal Preston Hosp, Preston
North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Rhyl
Singleton Hospital, Swansea
Royal Cornwall Hospital, Truro
Hoffmann-La Roche
INDUSTRY