A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

Status: Recruiting
Location: See all (237) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Genesis Cancer Center
WITHDRAWN
Hot Springs
Arizona
Arizona Clinical Research Center, Inc
RECRUITING
Tucson
California
Los Angeles Hematology Oncology Medical Group
RECRUITING
Los Angeles
Colorado
St Mary's Hospital and Medical Center
WITHDRAWN
Grand Junction
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Florida Cancer Specialists - EAST - SCRI - PPDS
WITHDRAWN
West Palm Beach
Illinois
Carle Cancer Center
RECRUITING
Urbana
Maryland
Maryland Oncology Hematology - Annapolis
RECRUITING
Annapolis
Michigan
St. Joseph Mercy Hospital
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
St. Joseph Mercy Oakland
RECRUITING
Pontiac
New York
Queens Hospital Cancer Center
RECRUITING
Jamaica
Clinical Research Alliance
RECRUITING
Westbury
Oklahoma
Hightower Clinical
WITHDRAWN
Oklahoma City
Tennessee
West Cancer Center
RECRUITING
Germantown
Texas
Texas Oncology - Austin
WITHDRAWN
Austin
CHRISTUS Spohn Cancer Center - Shoreline
RECRUITING
Corpus Christi
Texas Oncology - DFW
RECRUITING
Dallas
Texas Oncology - El Paso
RECRUITING
El Paso
Millennium Physicians
WITHDRAWN
Houston
CHRISTUS St. Michael Health System
RECRUITING
Texarkana
Virginia
Virginia Oncology Associates
WITHDRAWN
Norfolk
Washington
Swedish Cancer Institute - Edmonds Campus
RECRUITING
Edmonds
Swedish Cancer Institute - Issaquah
RECRUITING
Issaquah
Swedish Cancer Institute
ACTIVE_NOT_RECRUITING
Seattle
Other Locations
Argentina
Fundación CENIT para la Investigación en Neurociencias
RECRUITING
Buenos Aires
Centro Oncologico Korben
ACTIVE_NOT_RECRUITING
Ciudad Autonoma Buenos Aires
Centro Oncologico Riojano Integral (CORI)
RECRUITING
La Rioja
Fundacion Centro Oncologico de Integracion Regional (COIR)
RECRUITING
Mendoza
Hospital Provincial del Centenario
ACTIVE_NOT_RECRUITING
Rosario
Instituto de Oncología de Rosario
RECRUITING
Rosario
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
RECRUITING
San Juan
Belgium
Cliniques Universitaires St-Luc
WITHDRAWN
Brussels
GHdC Site Les Viviers
ACTIVE_NOT_RECRUITING
Charleroi
UZ Gent
RECRUITING
Ghent
Jessa Zkh (Campus Virga Jesse)
RECRUITING
Hasselt
UZ Leuven Gasthuisberg
ACTIVE_NOT_RECRUITING
Leuven
Clinique Ste-Elisabeth
RECRUITING
Namur
Brazil
Fundação Pio XII Hospital de Câncer de Barretos
ACTIVE_NOT_RECRUITING
Barretos
Pronutrir - suporte nutricional e quimioterapia ltda.
RECRUITING
Fortaleza
Hospital Araujo Jorge
RECRUITING
Goiânia
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
ACTIVE_NOT_RECRUITING
Ijuí
Hospital do Câncer de Londrina
ACTIVE_NOT_RECRUITING
Londrina
Hospital Nossa Senhora da Conceicao
RECRUITING
Porto Alegre
Hospital de Amor Amazônia
ACTIVE_NOT_RECRUITING
Porto Velho
Hospital do Cancer de Pernambuco - HCP
RECRUITING
Recife
Hospital Sao Rafael - HSR
RECRUITING
Salvador
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
ACTIVE_NOT_RECRUITING
São Paulo
Instituto do Cancer do Estado de Sao Paulo - ICESP
WITHDRAWN
São Paulo
China
Affiliated Hospital of Hebei University
ACTIVE_NOT_RECRUITING
Baoding
Peking University People's Hospital
ACTIVE_NOT_RECRUITING
Beijing
the First Affiliated Hospital of Bengbu Medical College
ACTIVE_NOT_RECRUITING
Bengbu
The First Hospital of Jilin University
ACTIVE_NOT_RECRUITING
Changchun
Hunan Cancer Hospital
ACTIVE_NOT_RECRUITING
Changsha
Sichuan Cancer Hospital
ACTIVE_NOT_RECRUITING
Chengdu
West China Hospital - Sichuan University
ACTIVE_NOT_RECRUITING
Chengdu
Fujian Cancer Hospital
ACTIVE_NOT_RECRUITING
Fuzhou
No. 900 Hospital (Fuzhou General Hospital)
ACTIVE_NOT_RECRUITING
Fuzhou
Zhejiang Cancer Hospital
ACTIVE_NOT_RECRUITING
Hangzhou
Zhejiang Provincial People?s Hospital
ACTIVE_NOT_RECRUITING
Hangzhou
Shandong Cancer Hospital
ACTIVE_NOT_RECRUITING
Jinan
The First Affiliated Hospital Of Jinzhou Medical University
ACTIVE_NOT_RECRUITING
Jinzhou
Yunnan Cancer Hospital
ACTIVE_NOT_RECRUITING
Kunming
Jiangxi Cancer Hospital
ACTIVE_NOT_RECRUITING
Nanchang
The Third Hospital of Nanchang
WITHDRAWN
Nanchang
Jiangsu Cancer Hospital
ACTIVE_NOT_RECRUITING
Nanjing
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
ACTIVE_NOT_RECRUITING
Nanjing
Guangxi Cancer Hospital of Guangxi Medical University
ACTIVE_NOT_RECRUITING
Nanning
The First Affiliated Hospital of China Medical University
ACTIVE_NOT_RECRUITING
Shenyang
Tianjin Cancer Hospital
ACTIVE_NOT_RECRUITING
Tianjin
The Tumor Hospital of Xinjiang Medical University
ACTIVE_NOT_RECRUITING
Ürümqi
Union Hospital Tongji Medical College Huazhong University of Science and Technology
ACTIVE_NOT_RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiao Tong University
ACTIVE_NOT_RECRUITING
Xi'an
Colombia
Clinica De La Costa
WITHDRAWN
Barranquilla
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
RECRUITING
Bogotá
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
RECRUITING
Bogota, D.c.
Oncomedica S.A.
RECRUITING
Montería
Oncólogos de Occidente
RECRUITING
Pereira
Egypt
Dar El salam Cancer Centre
RECRUITING
Cairo
National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement
RECRUITING
Cairo
Sohag Oncology Center
RECRUITING
Cairo
France
Institut Sainte Catherine
RECRUITING
Avignon
CH de la Côte Basque - Hôpital de Bayonne
RECRUITING
Bayonne
CHU Besançon - Hôpital Jean Minjoz
RECRUITING
Besançon
Polyclinique Bordeaux Nord Aquitaine
RECRUITING
Bordeaux
CHU de GRENOBLE
RECRUITING
Grenoble
CHD Vendée
RECRUITING
La Roche-sur-yon
Hopital Prive Jean Mermoz
RECRUITING
Lyon
INSTITUT CURIE_Site Paris
RECRUITING
Paris
Centre Catalan D' Oncologie
RECRUITING
Perpignan
CHU Poitiers
WITHDRAWN
Poitiers
Germany
Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim
RECRUITING
Bad Nauheim
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
ACTIVE_NOT_RECRUITING
Bamberg
Onkologische Schwerpunktpraxis Kurfürstendamm
WITHDRAWN
Berlin
Gynäkologisches Zentrum Bonn
RECRUITING
Bonn
Onkozentrum Dres. Göhler
ACTIVE_NOT_RECRUITING
Dresden
Kliniken Essen-Mitte
RECRUITING
Essen
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
HOPA MVZ GmbH
WITHDRAWN
Hamburg
Nationales Centrum für Tumorerkrankungen (NCT)
RECRUITING
Heidelberg
Ärztehaus am Bahnhofsplatz
ACTIVE_NOT_RECRUITING
Hildesheim
Universitätsklinikum des Saarlandes
RECRUITING
Homburg/saar
Dres. Andreas Köhler und Roswitha Fuchs
ACTIVE_NOT_RECRUITING
Langen
MVZ für Hämatologie und Onkologie Ravensburg GmBH
RECRUITING
Ravensburg
Caritas-Krankenhaus St. Josef
ACTIVE_NOT_RECRUITING
Regensburg
Klinikum Mutterhaus der Borromaeerinnen gGmbH
RECRUITING
Trier
Universitätsklinik Tübingen
ACTIVE_NOT_RECRUITING
Tübingen
Hungary
Budapesti Szent Margit Korhaz
RECRUITING
Budapest
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
WITHDRAWN
Budapest
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
RECRUITING
Budapest
Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz
ACTIVE_NOT_RECRUITING
Gyula
Somogy Varmegyei Kaposi Mor Oktato Korhaz
RECRUITING
Kaposvár
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
COMPLETED
Szolnok
Komarom-Eszergom Varmegyei Szent Borbala Korhaz
RECRUITING
Tatabánya
India
Manipal Hospital
RECRUITING
Bangalore
Netaji Subhas Chandra Bose Cancer Hospital
RECRUITING
Kolkata
TATA Medical Centre
ACTIVE_NOT_RECRUITING
Kolkata
Tata Memorial Hospital
RECRUITING
Mumbai
Fortis Hospital
RECRUITING
New Delhi
Rajiv Gandhi Cancer Inst.&Research Center
RECRUITING
New Delhi
Sahyadri Super Specialty Hospital Hadapsar
RECRUITING
Pune
Italy
Asst Degli Spedali Civili Di Brescia
RECRUITING
Brescia
Ospedale Civile
RECRUITING
Livorno
Istituto Europeo Di Oncologia
RECRUITING
Milan
Humanitas Centro Catanese Di Oncologia
RECRUITING
Misterbianco (ct)
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
RECRUITING
Napoli
IOV - Istituto Oncologico Veneto - IRCCS
RECRUITING
Padua
AUSL della Romagna
WITHDRAWN
Ravenna
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
RECRUITING
Reggio Emilia
Ospedale Infermi AUSL della Romagna
RECRUITING
Rimini
Policlinico Universitario Agostino Gemelli
ACTIVE_NOT_RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano
Jordan
King Hussein Cancer Center
ACTIVE_NOT_RECRUITING
Amman
Kenya
International Cancer Institute (ICI)
ACTIVE_NOT_RECRUITING
Eldoret
Aga Khan University Hospital
ACTIVE_NOT_RECRUITING
Nairobi
Lebanon
American University of Beirut - Medical Center
RECRUITING
Beirut
Hotel Dieu de France
RECRUITING
Beirut
Rizk Hospital
RECRUITING
Beirut
Notre Dame Des Secours Hospital
WITHDRAWN
Byblos
Mexico
Centro Estatal de Cancerologia de Chihuahua
RECRUITING
Chihuahua City
Iem-Fucam
RECRUITING
D.f.
Hospital Civil de Guadalajara Fray Antonio Alcalde
RECRUITING
Guadalajara
Investigacion Oncofarmaceutica
RECRUITING
La Paz
Health Pharma Professional Research
RECRUITING
Mexico City
Filios Alta Medicina
RECRUITING
Monterrey
Hospital Universitario
RECRUITING
Monterrey
Hospital Zambrano Hellion TecSalud
RECRUITING
Monterrey
Cuidados oncologicos
RECRUITING
Querétaro City
Oncologico Potosino
RECRUITING
San Luis Potosí City
Oman
Sultan Qaboos Comprehensive Cancer Care & Research Center
RECRUITING
Muscat
Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
SUSPENDED
Gdansk
Szpital Morski im.PCK
WITHDRAWN
Gdynia
Przychodnia Lekarska KOMED, Roman Karaszewski
RECRUITING
Konin
Szpital Wojewódzki im. Miko?aja Kopernika
RECRUITING
Koszalin
Opolskie Centrum Onkologii
RECRUITING
Opole
Ars Medical Sp. z o. o.
RECRUITING
Pi?a
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
RECRUITING
Późna
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
ACTIVE_NOT_RECRUITING
Rzeszów
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
ACTIVE_NOT_RECRUITING
Warsaw
Portugal
IPO de Coimbra
RECRUITING
Coimbra
Hospital da Luz
WITHDRAWN
Lisbon
Hospital de S. Francisco Xavier
RECRUITING
Lisbon
Hospital Beatriz Angelo
RECRUITING
Loures
IPO do Porto
RECRUITING
Porto
Qatar
Hamad Medical Corporation
WITHDRAWN
Doha
Republic of Korea
Kyungpook National University Chilgok Hospital
ACTIVE_NOT_RECRUITING
Daegu
National Cancer Center
ACTIVE_NOT_RECRUITING
Goyang-si
Asan Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Gangnam Severance Hospital
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul St Mary's Hospital
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
ACTIVE_NOT_RECRUITING
Seoul
Saudi Arabia
King Fahad Medical City
RECRUITING
Riyadh
King Faisal Specialist Hospital & Research Centre
RECRUITING
Riyadh
National Guard King Abdulaziz Medical City
RECRUITING
Riyadh
South Africa
Wits Donald Gordon Clinical Trial Centre
RECRUITING
Parktown, Johannesburg
Eastleigh Breast Care Centre
WITHDRAWN
Pretoria
University of Pretoria Oncology Department
WITHDRAWN
Pretoria
Spain
Hospital Clínic i Provincial
RECRUITING
Barcelona
Hospital Universitario Clínico San Cecilio
ACTIVE_NOT_RECRUITING
Granada
Hospital Juan Ramon Jimenez
RECRUITING
Huelva
Centro Oncologico MD Anderson Internacional
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clinico Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario de Canarias
ACTIVE_NOT_RECRUITING
San Cristóbal De La Laguna
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
RECRUITING
Sant Andreu De La Barca
Complejo Hospitalario Universitario de Santiago (CHUS)
RECRUITING
Santiago De Compostela
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
ACTIVE_NOT_RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
China Medical University Hospital
ACTIVE_NOT_RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
ACTIVE_NOT_RECRUITING
Taipei
Taipei Veterans General Hospital Office of General Surgery
RECRUITING
Taipei
Thailand
Rajavithi Hospital
RECRUITING
Bangkok
Ramathibodi Hospital
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital
RECRUITING
Chiang Mai
Songklanagarind Hospital
ACTIVE_NOT_RECRUITING
Songkhla
Turkey
Adana Baskent University Hospital
ACTIVE_NOT_RECRUITING
Adana
Ankara City Hospital
ACTIVE_NOT_RECRUITING
Ankara
Ankara Oncology Hospital
ACTIVE_NOT_RECRUITING
Ankara
Gazi Uni Medical Faculty Hospital
ACTIVE_NOT_RECRUITING
Ankara
Uludag Uni Hospital
WITHDRAWN
Bursa
Dicle University Faculty of Medicine
ACTIVE_NOT_RECRUITING
Diyarbakır
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
ACTIVE_NOT_RECRUITING
Edirne
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
ACTIVE_NOT_RECRUITING
Erzurum
Ac?badem Altunizade Hastanesi
ACTIVE_NOT_RECRUITING
Istanbul
Medipol University Medical Faculty
WITHDRAWN
Istanbul
Prof. Dr. Cemil Tascioglu City Hospital
ACTIVE_NOT_RECRUITING
Istanbul
Ege Uni Medical Faculty
ACTIVE_NOT_RECRUITING
Izmir
Katip Celebi University Ataturk Training and Research Hospital
ACTIVE_NOT_RECRUITING
Izmir
Kocaeli University Faculty of Medicine
ACTIVE_NOT_RECRUITING
İzmit
Erciyes Uni
ACTIVE_NOT_RECRUITING
Kayseri
Antalya Memorial Hastanesi
ACTIVE_NOT_RECRUITING
Kepez
Mersin City Education and Research Hospital
ACTIVE_NOT_RECRUITING
Mersin
Ondokuz Mayis Univ. Med. Fac.
ACTIVE_NOT_RECRUITING
Samsun
Ac?badem Maslak Hastanesi Büyükdere
WITHDRAWN
Sar?yer/?stanbul
Medical Park Seyhan Hospital
ACTIVE_NOT_RECRUITING
Seyhan
Hacettepe Uni Medical Faculty Hospital
WITHDRAWN
Sihhiye/ankara
Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
ACTIVE_NOT_RECRUITING
Tekirdağ
Karadeniz Tecnical University Medical Faculty
WITHDRAWN
Trabzon
Uganda
Uganda Cancer Institute
ACTIVE_NOT_RECRUITING
Kampala
United Arab Emirates
Burjeel Medical City-Abu Dhabi
RECRUITING
Abu Dhabi
Tawam Hospital
RECRUITING
Al Ain City
United Kingdom
Ysbyty Gwynedd Hospital
RECRUITING
Bangor
Royal United Hospital
RECRUITING
Bath
Blackpool Victoria Hospital
RECRUITING
Blackpool
University Hospital North Tees
RECRUITING
Cleveland
Charing Cross Hospital
RECRUITING
London
Maidstone Hospital
RECRUITING
Maidstone
Nottingham University Hospitals NHS Trust - City Hospital
RECRUITING
Nottingham
Royal Preston Hosp
COMPLETED
Preston
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
COMPLETED
Rhyl
Queen's Hospital
WITHDRAWN
Romford
Singleton Hospital
RECRUITING
Swansea
Royal Cornwall Hospital
RECRUITING
Truro
Contact Information
Primary
Reference Study ID Number: WO43571 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2022-07-18
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 922
Treatments
Other: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Active_comparator: Arm A, Maintenance Therapy: Phesgo
Experimental: Arm B, Maintenance Therapy: Giredestrant plus Phesgo
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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