AzTrials
AzTrials

Locally Advanced or Metastatic Breast CancerPhase 3NCT05296798

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)

A Phase 3 study testing Phesgo, Giredestrant and Docetaxel in people with Locally Advanced or Metastatic Breast Cancer, run by Hoffmann-La Roche at 198 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Phesgo, Giredestrant and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
922 participants
Where
198 sitesin 29 countries
Study dates
18 Jul 2022to 31 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

198 sites in 29 countries.

198 sites in 29 countries

China23 sites

  • Affiliated Hospital of Hebei University

    Baoding, 071000

  • Peking University People's Hospital

    Beijing, 100044

  • the First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233000

  • The First Hospital of Jilin University

    Changchun, 130021

  • Hunan Cancer Hospital

    Changsha, 410013

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital - Sichuan University

    Chengdu, 610047

  • No. 900 Hospital (Fuzhou General Hospital)

    Fuzhou, 350009

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Zhejiang Provincial People?s Hospital

    Hangzhou, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Shandong Cancer Hospital

    Jinan, 250117

  • The First Affiliated Hospital Of Jinzhou Medical University

    Jinzhou, 121001

  • Yunnan Cancer Hospital

    Kunming, 650118

  • Jiangxi Cancer Hospital

    Nanchang, 330006

  • Jiangsu Cancer Hospital

    Nanjing, 210009

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

    Nanjing, 210029

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • The First Affiliated Hospital of China Medical University

    Shenyang, 110001

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • The Tumor Hospital of Xinjiang Medical University

    Ürümqi, 830000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

Other trials in China

Turkey (Türkiye)18 sites

  • Adana Baskent University Hospital

    Adana, 01120

  • Ankara Oncology Hospital

    Ankara, 06200

  • Gazi Uni Medical Faculty Hospital

    Ankara, 06500

  • Ankara City Hospital

    Ankara, 06800

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280

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

    Edirne, 22030

  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

    Erzurum, 25240

  • Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul, 34384

  • Ac?badem Altunizade Hastanesi

    Istanbul, 34662

  • Ege Uni Medical Faculty

    Izmir, 35100

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360

  • Kocaeli University Faculty of Medicine

    İzmit, 31380

  • Erciyes Uni

    Kayseri, 38039

  • Antalya Memorial Hastanesi

    Kepez, 07020

  • Mersin City Education and Research Hospital

    Mersin, 33240

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139

  • Medical Park Seyhan Hospital

    Seyhan, 01140

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

    Tekirdağ, 59030

Other trials in Turkey (Türkiye)

Germany12 sites

  • Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim

    Bad Nauheim, 61231

  • Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

    Bamberg, 96049

  • Kliniken Essen-Mitte

    Essen, 45136

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

  • Ärztehaus am Bahnhofsplatz

    Hildesheim, 31134

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66424

  • Dres. Andreas Köhler und Roswitha Fuchs

    Langen, 63225

  • MVZ für Hämatologie und Onkologie Ravensburg GmBH

    Ravensburg, 88212

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH;Gynäkologie

    Trier, 54290

  • Universitätsklinik Tübingen

    Tübingen, 72076

Other trials in Germany

Italy11 sites

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123

  • Ospedale Civile

    Livorno, Tuscany, 57100

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Humanitas Centro Catanese Di Oncologia

    Misterbianco (CT), Sicily, 95045

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128

  • Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

    Reggio Emilia, Emilia-Romagna, 42123

  • Ospedale Infermi AUSL della Romagna

    Rimini, Emilia-Romagna, 47900

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

Other trials in Italy

Spain11 sites

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

  • Hospital Juan Ramon Jimenez

    Huelva, 21005

  • Centro Oncologico MD Anderson Internacional

    Madrid, 28033

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

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

    Sant Andreu de la Barca, Barcelona, 08740

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

    Valencia, 46015

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United States10 sites

  • Maryland Oncology Hematology - Annapolis

    Annapolis, Maryland, 21401

  • Texas Oncology - DFW

    Dallas, Texas, 75246

  • Swedish Cancer Institute - Edmonds Campus

    Edmonds, Washington, 98026

  • Texas Oncology - El Paso

    El Paso, Texas, 79902

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Swedish Cancer Institute - Issaquah

    Issaquah, Washington, 98029

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Arizona Clinical Research Center, Inc

    Tucson, Arizona, 85715

Other trials in United States

Brazil10 sites

  • Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Pronutrir - suporte nutricional e quimioterapia ltda.

    Fortaleza, Ceará, 60810-180

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital do Câncer de Londrina

    Londrina, Paraná, 86015-520

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital de Amor Amazônia

    Porto Velho, Rondônia, 76834-899

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190

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

    São Paulo, São Paulo, 01317-001

Other trials in Brazil

Mexico10 sites

  • Centro Estatal de Cancerologia de Chihuahua

    Chihuahua City, 31000

  • Iem-Fucam

    D.F., Mexico CITY (federal District), 04980

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Investigacion Oncofarmaceutica

    La Paz, Baja California Sur, 23040

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Filios Alta Medicina

    Monterrey, Nuevo León, 64460

  • Hospital Universitario

    Monterrey, Nuevo León, 64460

  • Hospital Zambrano Hellion TecSalud

    Monterrey, Nuevo León

  • Cuidados oncologicos

    Querétaro City, Querétaro, 76000

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78209

Other trials in Mexico

United Kingdom10 sites

  • Royal United Hospital

    Bath, BA1 3NG

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • University Hospital North Tees

    Cleveland, TS19 8PE

  • Charing Cross Hospital

    London, W6 8RF

  • Maidstone Hospital

    Maidstone, ME16 9QQ

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

  • Royal Preston Hosp

    Preston, PR2 9HT

  • North Wales Cancer Treatment Centre, Glan Clwyd Hospital

    Rhyl, LL18 5UJ

  • Singleton Hospital

    Swansea, SA2 8QA

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

France9 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • CH de la Côte Basque - Hôpital de Bayonne

    Bayonne, 64109

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • CHU de GRENOBLE

    Grenoble, 38043

  • CHD Vendée

    La Roche-sur-Yon, 85025

  • Hopital Prive Jean Mermoz

    Lyon, 69373

  • INSTITUT CURIE_Site Paris

    Paris, 75005

  • Centre Catalan D' Oncologie

    Perpignan, 66000

Other trials in France

Poland8 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581

  • Opolskie Centrum Onkologii

    Opole, 45-060

  • Ars Medical Sp. z o. o.

    Pi?a, 64-920

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu

    Późna, 60-569

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

    Rzeszów, 35-021

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

    Warsaw, 02-781

Other trials in Poland

Argentina7 sites

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

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Fundacion Centro Oncologico de Integracion Regional (COIR)

    Mendoza, M5500AYB

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, J5400DIL

Other trials in Argentina

India7 sites

  • Manipal Hospital

    Bangalore, Karnataka, 560017

  • Netaji Subhas Chandra Bose Cancer Hospital

    Kolkata, West Bengal, 700094

  • TATA Medical Centre

    Kolkata, West Bengal, 700156

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • Rajiv Gandhi Cancer Inst.&Research Center

    New Delhi, National Capital Territory of Delhi, 110085

  • Fortis Hospital

    New Delhi, National Capital Territory of Delhi, 110088

  • Sahyadri Super Specialty Hospital Hadapsar

    Pune, Maharashtra, 411028

Other trials in India

South Korea7 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Hungary6 sites

  • Budapesti Szent Margit Korhaz

    Budapest, 1032

  • Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)

    Budapest, 1082

  • Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz

    Gyula, 5700

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004

  • Komarom-Eszergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

Other trials in Hungary

Belgium5 sites

  • GHdC Site Les Viviers

    Charleroi, 6000

  • UZ Gent

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Clinique Ste-Elisabeth

    Namur, 5000

Other trials in Belgium

Colombia5 sites

  • Clinica De La Costa

    Barranquilla, 080020

  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

    Bogotá, 111321

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

    Bogota, D.C., 110131

  • Oncomedica S.A.

    Montería, 230002

  • Oncólogos de Occidente

    Pereira, 600004

Other trials in Colombia

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 00704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital Office of General Surgery

    Taipei, 11217

Other trials in Taiwan

Portugal4 sites

  • IPO de Coimbra

    Coimbra, 3000-075

  • Hospital de S. Francisco Xavier

    Lisbon, 1495-005

  • Hospital Beatriz Angelo

    Loures, 2674-514

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

Thailand4 sites

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Egypt3 sites

  • Dar El salam Cancer Centre

    Cairo

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

    Cairo

  • Sohag Oncology Center

    Cairo

Other trials in Egypt

Saudi Arabia3 sites

  • King Faisal Specialist Hospital & Research Centre

    Riyadh, 11211

  • National Guard King Abdulaziz Medical City

    Riyadh, 11426

  • King Fahad Medical City

    Riyadh, 11525

Other trials in Saudi Arabia

Kenya2 sites

  • International Cancer Institute (ICI)

    Eldoret, 30100

  • The Aga Khan University-Kenya.

    Nairobi, 00100

Other trials in Kenya

Lebanon2 sites

  • Rizk Hospital

    Beirut, 0

  • American University of Beirut - Medical Center

    Beirut, 1107 2020

Other trials in Lebanon

United Arab Emirates2 sites

  • Burjeel Medical City-Abu Dhabi

    Abu Dhabi

  • Tawam Hospital

    Al Ain City, 15258

Other trials in United Arab Emirates

Jordan1 site

  • King Hussein Cancer Center

    Amman, 1269

Other trials in Jordan

Oman1 site

  • Sultan Qaboos Comprehensive Cancer Care & Research Center

    Muscat

Other trials in Oman

South Africa1 site

  • Wits Donald Gordon Clinical Trial Centre

    Parktown, Johannesburg, 2193

Other trials in South Africa

Uganda1 site

  • Uganda Cancer Institute

    Kampala, 88560

Other trials in Uganda

About this study

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

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.

Being tested
Phesgo, Giredestrant, Docetaxel, Paclitaxel, LHRH Agonist
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhesgoDrug

    Also called Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, Pertuzumab, Trastuzumab, and rHuPH20, Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), RO7198574

    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).

  • GiredestrantDrug

    Also called GDC-9545, RO7197597, RG6171

    A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle.

  • DocetaxelDrug

    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.

  • PaclitaxelDrug

    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 AgonistDrug

    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 ChoiceDrug

    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.

Study groups in NCT05296798
Study groupRoleWhat they receive
Induction Therapy: Phesgo plus Taxane-Based ChemotherapyOtherNot described
Receives: Drug: Phesgo; Drug: Docetaxel; Drug: Paclitaxel
Arm A, Maintenance Therapy: PhesgoActive comparatorNot described
Receives: Drug: Phesgo; Drug: LHRH Agonist; Drug: Optional Endocrine Therapy of Investigator's Choice
Arm B, Maintenance Therapy: Giredestrant plus PhesgoExperimentalNot described
Receives: Drug: Phesgo; Drug: Giredestrant; Drug: LHRH Agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1

    Measured: From randomization for maintenance therapy to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 53 months)

Secondary outcomes (12)

  1. Overall Survival

    Measured: From randomization for maintenance therapy to death from any cause (up to 98 months)

  2. Objective Response Rate, as Determined by the Investigator According to RECIST v1.1

    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.

    Measured: From randomization for maintenance therapy to disease progression or death (up to 53 months)

  3. Duration of Response, as Determined by the Investigator According to RECIST v1.1

    Measured: From first occurrence of documented objective response after randomization for maintenance therapy to disease progression or death from any cause, whichever occurs first (up to 53 months)

  4. Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1

    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.

    Measured: From randomization for maintenance therapy to disease progression or death (up to 53 months)

  5. Mean Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire

    Measured: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 8 years)

  6. Mean Change from Baseline in the Role Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire

    Measured: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 8 years)

  7. Mean Physical Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire

    Measured: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 8 years)

  8. Mean Change from Baseline in the Physical Functioning Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire

    Measured: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 8 years)

  9. Mean Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire

    Measured: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 8 years)

  10. Mean Change from Baseline in the Global Health Status/Quality of Life Score Over Time, as Assessed Using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) Questionnaire

    Measured: Maintenance Cycles 1 (Baseline), 3, 6, 9, 12, 15, 18, once every 6 cycles from Cycles 24 to 90 (1 cycle is 21 days), treatment discontinuation, every 6 months and every year for Follow-up Years 1-2 and 3-5, respectively (up to 8 years)

  11. Number of Participants with at Least One Adverse Event, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0)

    Measured: From Baseline until 28 days after the final dose of study treatment (up to 8 years, 5 months)

  12. Number of Participants with Abnormalities in Clinical Laboratory Test Results

    Measured: From Baseline until 28 days after the final dose of study treatment (up to 8 years, 5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start18 Jul 2022
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
922 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05296798
Sponsor's protocol ID
WO43571
Other IDs
2022-500014-26-00
Status last verified
Sep 2026
First submitted
23 Mar 2022
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Kuemmel S, Harper-Wynne C, Park YH, Franke F, de Laurentiis M, Schumacher-Wulf E, Eiger D, Heeson S, Cardona A, Ozyilkan O, Morales-Vasquez F, Metcalfe C, Hafner M, Restuccia E, O'Shaughnessy J. heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer. BMC Cancer. 2024 May 24;24(1):641. doi: 10.1186/s12885-024-12179-9.

    PubMed 38789924

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phesgo, Giredestrant and Docetaxel in people with Locally Advanced or Metastatic Breast Cancer, run by Hoffmann-La Roche at 198 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in China, Turkey (Türkiye), Germany, Italy, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1 (time frame: From randomization for maintenance therapy to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 53 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05296798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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