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 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
2 other identifiers
interventional
922
29 countries
206
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2022
Longer than P75 for phase_3
206 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 16, 2026
April 1, 2026
5.3 years
March 23, 2022
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
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)
Overall Survival
From randomization for maintenance therapy to death from any cause (up to 98 months)
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
From randomization for maintenance therapy to disease progression or death (up to 53 months)
Duration of Response, as Determined by the Investigator According to RECIST v1.1
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)
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
From randomization for maintenance therapy to disease progression or death (up to 53 months)
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
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 more secondary outcomes
Study Arms (3)
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
OTHERArm A, Maintenance Therapy: Phesgo
ACTIVE COMPARATORArm B, Maintenance Therapy: Giredestrant plus Phesgo
EXPERIMENTALInterventions
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.
A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (206)
Arizona Clinical Research Center, Inc
Tucson, Arizona, 85715, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Maryland Oncology Hematology - Annapolis
Annapolis, Maryland, 21401, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Queens Hospital Cancer Center
Jamaica, New York, 11432, United States
Clinical Research Alliance
Westbury, New York, 11590, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
CHRISTUS Spohn Cancer Center - Shoreline
Corpus Christi, Texas, 78404, United States
Texas Oncology - DFW
Dallas, Texas, 75246, United States
Texas Oncology - El Paso
El Paso, Texas, 79902, United States
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, 98026, United States
Swedish Cancer Institute - Issaquah
Issaquah, Washington, 98029, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE, Argentina
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Fundacion Centro Oncologico de Integracion Regional (COIR)
Mendoza, M5500AYB, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, J5400DIL, Argentina
GHdC Site Les Viviers
Charleroi, 6000, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Pronutrir - suporte nutricional e quimioterapia ltda.
Fortaleza, Ceará, 60810-180, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, 86015-520, Brazil
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital de Amor Amazônia
Porto Velho, Rondônia, 76834-899, Brazil
Fundação Pio XII Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001, Brazil
Affiliated Hospital of Hebei University
Baoding, 071000, China
Peking University People's Hospital
Beijing, 100044, China
the First Affiliated Hospital of Bengbu Medical College
Bengbu, 233000, China
The First Hospital of Jilin University
Changchun, 130021, China
Hunan Cancer Hospital
Changsha, 410013, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital - Sichuan University
Chengdu, 610047, China
No. 900 Hospital (Fuzhou General Hospital)
Fuzhou, 350009, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Zhejiang Provincial People?s Hospital
Hangzhou, 310014, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Shandong Cancer Hospital
Jinan, 250117, China
The First Affiliated Hospital Of Jinzhou Medical University
Jinzhou, 121001, China
Yunnan Cancer Hospital
Kunming, 650118, China
Jiangxi Cancer Hospital
Nanchang, 330006, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
The First Affiliated Hospital of China Medical University
Shenyang, 110001, China
Tianjin Cancer Hospital
Tianjin, 300060, China
The Tumor Hospital of Xinjiang Medical University
Ürümqi, 830000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430023, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061, China
Clinica De La Costa
Barranquilla, 080020, Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., 110131, Colombia
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogotá, 111321, Colombia
Oncomedica S.A.
Montería, 230002, Colombia
Oncólogos de Occidente
Pereira, 600004, 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, 84918, France
CH de la Côte Basque - Hôpital de Bayonne
Bayonne, 64109, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077, France
CHU de GRENOBLE
Grenoble, 38043, France
CHD Vendée
La Roche-sur-Yon, 85025, France
Hopital Prive Jean Mermoz
Lyon, 69373, France
INSTITUT CURIE_Site Paris
Paris, 75005, France
Centre Catalan D' Oncologie
Perpignan, 66000, France
Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim
Bad Nauheim, 61231, Germany
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
Bamberg, 96049, Germany
Onkozentrum Dres. Göhler
Dresden, 01127, Germany
Kliniken Essen-Mitte
Essen, 45136, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120, Germany
Ärztehaus am Bahnhofsplatz
Hildesheim, 31134, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66424, Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225, Germany
MVZ für Hämatologie und Onkologie Ravensburg GmBH
Ravensburg, 88212, Germany
Caritas-Krankenhaus St. Josef
Regensburg, 93053, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH;Gynäkologie
Trier, 54290, Germany
Universitätsklinik Tübingen
Tübingen, 72076, Germany
Budapesti Szent Margit Korhaz
Budapest, 1032, Hungary
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
Budapest, 1082, Hungary
Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5004, Hungary
Komarom-Eszergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Manipal Hospital
Bangalore, Karnataka, 560017, India
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
Sahyadri Super Specialty Hospital Hadapsar
Pune, Maharashtra, 411028, India
Rajiv Gandhi Cancer Inst.&Research Center
New Delhi, National Capital Territory of Delhi, 110085, India
Fortis Hospital
New Delhi, National Capital Territory of Delhi, 110088, India
Netaji Subhas Chandra Bose Cancer Hospital
Kolkata, West Bengal, 700094, India
TATA Medical Centre
Kolkata, West Bengal, 700156, India
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania, 80131, Italy
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
Reggio Emilia, Emilia-Romagna, 42123, Italy
Ospedale Infermi AUSL della Romagna
Rimini, Emilia-Romagna, 47900, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, 95045, Italy
Ospedale Civile
Livorno, Tuscany, 57100, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128, Italy
King Hussein Cancer Center
Amman, 1269, Jordan
International Cancer Institute (ICI)
Eldoret, 30100, Kenya
The Aga Khan University-Kenya.
Nairobi, 00100, Kenya
Rizk Hospital
Beirut, 0, Lebanon
American University of Beirut - Medical Center
Beirut, 1107 2020, Lebanon
Investigacion Oncofarmaceutica
La Paz, Baja California Sur, 23040, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Iem-Fucam
D.F., Mexico CITY (federal District), 04980, Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100, Mexico
Filios Alta Medicina
Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario
Monterrey, Nuevo León, 64460, Mexico
Hospital Zambrano Hellion TecSalud
Monterrey, Nuevo León, Mexico
Cuidados oncologicos
Querétaro City, Querétaro, 76000, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, 78209, Mexico
Centro Estatal de Cancerologia de Chihuahua
Chihuahua City, 31000, Mexico
Sultan Qaboos Comprehensive Cancer Care & Research Center
Muscat, Oman
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-214, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500, Poland
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, 75-581, Poland
Opolskie Centrum Onkologii
Opole, 45-060, Poland
Ars Medical Sp. z o. o.
Pi?a, 64-920, Poland
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
Późna, 60-355, Poland
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, 35-021, Poland
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781, Poland
IPO de Coimbra
Coimbra, 3000-075, Portugal
Hospital de S. Francisco Xavier
Lisbon, 1495-005, Portugal
Hospital Beatriz Angelo
Loures, 2674-514, Portugal
IPO do Porto
Porto, 4200-072, Portugal
King Faisal Specialist Hospital & Research Centre
Riyadh, 11211, Saudi Arabia
National Guard King Abdulaziz Medical City
Riyadh, 11426, Saudi Arabia
King Fahad Medical City
Riyadh, 11525, Saudi Arabia
Wits Donald Gordon Clinical Trial Centre
Parktown, Johannesburg, 2193, South Africa
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Sant Andreu de la Barca, Barcelona, 08740, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, 15706, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital Clínic i Provincial
Barcelona, 08036, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18016, Spain
Hospital Juan Ramon Jimenez
Huelva, 21005, Spain
Centro Oncologico MD Anderson Internacional
Madrid, 28033, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, 46015, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
National Cheng Kung University Hospital
Tainan, 00704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital Office of General Surgery
Taipei, 11217, Taiwan
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Adana Baskent University Hospital
Adana, 01120, Turkey (Türkiye)
Ankara Oncology Hospital
Ankara, 06200, Turkey (Türkiye)
Gazi Uni Medical Faculty Hospital
Ankara, 06500, Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, 21280, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030, Turkey (Türkiye)
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, 25240, Turkey (Türkiye)
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, 34384, Turkey (Türkiye)
Ac?badem Altunizade Hastanesi
Istanbul, 34662, Turkey (Türkiye)
Ege Uni Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
Kocaeli University Faculty of Medicine
İzmit, 31380, Turkey (Türkiye)
Erciyes Uni
Kayseri, 38039, Turkey (Türkiye)
Antalya Memorial Hastanesi
Kepez, 07020, Turkey (Türkiye)
Mersin City Education and Research Hospital
Mersin, 33240, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, 55139, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, 01140, Turkey (Türkiye)
Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
Tekirdağ, 59030, Turkey (Türkiye)
Uganda Cancer Institute
Kampala, 88560, Uganda
Burjeel Medical City-Abu Dhabi
Abu Dhabi, United Arab Emirates
Tawam Hospital
Al Ain City, 15258, United Arab Emirates
Ysbyty Gwynedd Hospital
Bangor, LL57 2PW, United Kingdom
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
University Hospital North Tees
Cleveland, TS19 8PE, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB, United Kingdom
Royal Preston Hosp
Preston, PR2 9HT, United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, LL18 5UJ, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Related Publications (1)
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.
PMID: 38789924DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2022
First Posted
March 25, 2022
Study Start
July 18, 2022
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
December 31, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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