Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05296798
PHASE3

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

922

Start Date

2022-07-18

Completion Date

2030-12-31

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DRUG

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).

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Locations (208)

Arizona Clinical Research Center, Inc

Tucson, Arizona, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Carle Cancer Center

Urbana, Illinois, United States

Maryland Oncology Hematology - Annapolis

Annapolis, Maryland, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Queens Hospital Cancer Center

Jamaica, New York, United States

Clinical Research Alliance

Westbury, New York, United States

West Cancer Center

Germantown, Tennessee, United States

CHRISTUS Spohn Cancer Center - Shoreline

Corpus Christi, Texas, United States

Texas Oncology - DFW

Dallas, Texas, United States

Texas Oncology - El Paso

El Paso, Texas, United States

CHRISTUS St. Michael Health System

Texarkana, Texas, United States

Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington, United States

Swedish Cancer Institute - Issaquah

Issaquah, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Fundacion Centro Oncologico de Integracion Regional (COIR)

Mendoza, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

GHdC Site Les Viviers

Charleroi, Belgium

UZ Gent

Ghent, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Clinique Ste-Elisabeth

Namur, Belgium

Pronutrir - suporte nutricional e quimioterapia ltda.

Fortaleza, Ceará, Brazil

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Hospital do Câncer de Londrina

Londrina, Paraná, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor Amazônia

Porto Velho, Rondônia, Brazil

Fundação Pio XII Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, Brazil

Affiliated Hospital of Hebei University

Baoding, China

Peking University People's Hospital

Beijing, China

the First Affiliated Hospital of Bengbu Medical College

Bengbu, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital - Sichuan University

Chengdu, China

No. 900 Hospital (Fuzhou General Hospital)

Fuzhou, China

Fujian Cancer Hospital

Fuzhou, China

Zhejiang Provincial People?s Hospital

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Shandong Cancer Hospital

Jinan, China

The First Affiliated Hospital Of Jinzhou Medical University

Jinzhou, China

Yunnan Cancer Hospital

Kunming, China

Jiangxi Cancer Hospital

Nanchang, China

Jiangsu Cancer Hospital

Nanjing, China

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Nanjing, China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, China

The First Affiliated Hospital of China Medical University

Shenyang, China

Tianjin Cancer Hospital

Tianjin, China

The Tumor Hospital of Xinjiang Medical University

Ürümqi, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, China

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogota, D.C., Colombia

Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

Bogotá, Colombia

Oncomedica S.A.

Montería, Colombia

Oncólogos de Occidente

Pereira, Colombia

Dar El salam Cancer Centre

Cairo, Egypt

National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement

Cairo, Egypt

Sohag Oncology Center

Cairo, Egypt

Institut Sainte Catherine

Avignon, France

CH de la Côte Basque - Hôpital de Bayonne

Bayonne, France

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

CHU de GRENOBLE

Grenoble, France

CHD Vendée

La Roche-sur-Yon, France

Hopital Prive Jean Mermoz

Lyon, France

INSTITUT CURIE_Site Paris

Paris, France

Centre Catalan D' Oncologie

Perpignan, France

Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim

Bad Nauheim, Germany

Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

Bamberg, Germany

Gynäkologisches Zentrum Bonn

Bonn, Germany

Onkozentrum Dres. Göhler

Dresden, Germany

Kliniken Essen-Mitte

Essen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

Ärztehaus am Bahnhofsplatz

Hildesheim, Germany

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

Dres. Andreas Köhler und Roswitha Fuchs

Langen, Germany

MVZ für Hämatologie und Onkologie Ravensburg GmBH

Ravensburg, Germany

Caritas-Krankenhaus St. Josef

Regensburg, Germany

Klinikum Mutterhaus der Borromaeerinnen gGmbH

Trier, Germany

Universitätsklinik Tübingen

Tübingen, Germany

Budapesti Szent Margit Korhaz

Budapest, Hungary

Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)

Budapest, Hungary

Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz

Gyula, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, Hungary

Komarom-Eszergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Manipal Hospital

Bangalore, Karnataka, India

Tata Memorial Hospital

Mumbai, Maharashtra, India

Sahyadri Super Specialty Hospital Hadapsar

Pune, Maharashtra, India

Rajiv Gandhi Cancer Inst.&Research Center

New Delhi, National Capital Territory of Delhi, India

Fortis Hospital

New Delhi, National Capital Territory of Delhi, India

Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, India

TATA Medical Centre

Kolkata, West Bengal, India

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, Italy

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

Naples, Campania, Italy

Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

Reggio Emilia, Emilia-Romagna, Italy

Ospedale Infermi AUSL della Romagna

Rimini, Emilia-Romagna, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily, Italy

Ospedale Civile

Livorno, Tuscany, Italy

IOV - Istituto Oncologico Veneto - IRCCS

Padova, Veneto, Italy

King Hussein Cancer Center

Amman, Jordan

International Cancer Institute (ICI)

Eldoret, Kenya

The Aga Khan University-Kenya.

Nairobi, Kenya

Rizk Hospital

Beirut, Lebanon

American University of Beirut - Medical Center

Beirut, Lebanon

Investigacion Oncofarmaceutica

La Paz, Baja California Sur, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Iem-Fucam

D.F., Mexico CITY (federal District), Mexico

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

Filios Alta Medicina

Monterrey, Nuevo León, Mexico

Hospital Universitario

Monterrey, Nuevo León, Mexico

Hospital Zambrano Hellion TecSalud

Monterrey, Nuevo León, Mexico

Cuidados oncologicos

Querétaro City, Querétaro, Mexico

Oncologico Potosino

San Luis Potosí City, San Luis Potosí, Mexico

Centro Estatal de Cancerologia de Chihuahua

Chihuahua City, Mexico

Sultan Qaboos Comprehensive Cancer Care & Research Center

Muscat, Oman

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, Poland

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, Poland

Opolskie Centrum Onkologii

Opole, Poland

Ars Medical Sp. z o. o.

Pi?a, Poland

Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu

Późna, Poland

MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

Rzeszów, Poland

Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

Warsaw, Poland

IPO de Coimbra

Coimbra, Portugal

Hospital de S. Francisco Xavier

Lisbon, Portugal

Hospital Beatriz Angelo

Loures, Portugal

IPO do Porto

Porto, Portugal

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

National Guard King Abdulaziz Medical City

Riyadh, Saudi Arabia

King Fahad Medical City

Riyadh, Saudi Arabia

Wits Donald Gordon Clinical Trial Centre

Parktown, Johannesburg, South Africa

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St Mary's Hospital

Seoul, South Korea

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Sant Andreu de la Barca, Barcelona, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Clínic i Provincial

Barcelona, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Juan Ramon Jimenez

Huelva, Spain

Centro Oncologico MD Anderson Internacional

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Changhua Christian Hospital

Changhua, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital Office of General Surgery

Taipei, Taiwan

Rajavithi Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Adana Baskent University Hospital

Adana, Turkey (Türkiye)

Ankara Oncology Hospital

Ankara, Turkey (Türkiye)

Gazi Uni Medical Faculty Hospital

Ankara, Turkey (Türkiye)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, Turkey (Türkiye)

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, Turkey (Türkiye)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)

Ac?badem Altunizade Hastanesi

Istanbul, Turkey (Türkiye)

Ege Uni Medical Faculty

Izmir, Turkey (Türkiye)

Katip Celebi University Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Kocaeli University Faculty of Medicine

İzmit, Turkey (Türkiye)

Erciyes Uni

Kayseri, Turkey (Türkiye)

Antalya Memorial Hastanesi

Kepez, Turkey (Türkiye)

Mersin City Education and Research Hospital

Mersin, Turkey (Türkiye)

Ondokuz Mayis Univ. Med. Fac.

Samsun, Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, Turkey (Türkiye)

Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100

Tekirdağ, Turkey (Türkiye)

Uganda Cancer Institute

Kampala, Uganda

Burjeel Medical City-Abu Dhabi

Abu Dhabi, United Arab Emirates

Tawam Hospital

Al Ain City, United Arab Emirates

Ysbyty Gwynedd Hospital

Bangor, United Kingdom

Royal United Hospital

Bath, United Kingdom

Blackpool Victoria Hospital

Blackpool, United Kingdom

University Hospital North Tees

Cleveland, United Kingdom

Charing Cross Hospital

London, United Kingdom

Maidstone Hospital

Maidstone, United Kingdom

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, United Kingdom

Royal Preston Hosp

Preston, United Kingdom

North Wales Cancer Treatment Centre, Glan Clwyd Hospital

Rhyl, United Kingdom

Singleton Hospital

Swansea, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom