A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Early Breast Cancer Clinical Trial

Official title:

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961996
• Other study ID #: GO42784
• Secondary ID: 2021-000129-2820
• Status: Recruiting
• Phase: Phase 3
• Start date: August 27, 2021
• Est. completion date: November 21, 2033

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: GO42784 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4200
• Est. completion date: November 21, 2033
• Est. primary completion date: December 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Primary Study Inclusion Criteria:

• Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen

• Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity

• Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])

• Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.

• Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade =2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)

• Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery

• Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.

• Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2

• Able and willing to swallow, retain, and absorb oral medication

• Adequate organ function

Substudy Inclusion Criteria:

To be eligible for substudy participation, in addition to meeting the inclusion criteria in the primary protocol, participants must also meet the following modified criteria:

• Patients who received adjuvant radiotherapy must have completed radiotherapy prior to enrollment, and patients must have recovered (to Grade =1) from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.

Primary Study Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice

• Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study

• Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed.

• Active cardiac disease or history of cardiac dysfunction

• Diagnosed with Stage IV breast cancer

• A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.

• A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer

• Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed.

• Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis

• Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment

• Known allergy or hypersensitivity to any of the study drugs or any of their excipients

• Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists

• A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism

• Renal dysfunction that requires dialysis

• A major surgical procedure unrelated to breast cancer within 28 days prior to randomization

• A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening

• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study

• Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

Substudy Exclusion Criteria:

Potential participants are excluded from the substudy if any criteria from t\he primary study or the following criteria apply:

• Prior participation in the GO42784 primary study

• Received a CDK4/6i as (neo)adjuvant therapy prior to enrollment

• Treatment with moderate CYP3A inducers, strong CYP3A inducers or strong CYP3A inhibitors within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Drug:
• Giredestrant
Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).
• Endocrine Therapy of Physician's Choice
The endocrine therapy of physician's choice (TPC) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive TPC daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing TPC after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of TPC should be performed in accordance with the local prescribing information for the respective product.
• LHRH Agonist
A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
• Abemaciclib
Abemaciclib 150 mg will be administered orally (PO) twice a day (BID) on Days 1-28 during each 28-day cycle for 2 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Locations

Country	Name	City	State
Argentina	Hospital Italiano Regional del Sur	Bahia Blanca
Argentina	Fundacion Intectus	Bariloche
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas-Mar del Plata	Buenos Aires
Argentina	Instituto de Investigaciones Metabólicas (IDIM); Diabetes	Buenos Aires
Argentina	Centro Oncologico Korben	Caba
Argentina	Fundacion Medica de Rio Negro Y Nuequen	Cipoletti
Argentina	Consultorios Médicos Dr. Doreski	Ciudad Autonoma Buenos Aires
Argentina	Centro Medico Privado CEMAIC	Cordoba
Argentina	Sanatorio Allende Servicio Nefrología	Córdoba
Argentina	Fundación Ars Medica	Jujuy
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Argentina	Centro de Investigaciones Medicas Mar Del Plata	Mar Del Plata
Argentina	Hospital Privado de La Comunidad	Mar Del Plata
Argentina	Centro de Investigacion Pergamino SA	Pergamino
Argentina	Hospital Alemán	Recoleta
Argentina	Instituto de Especialidades de la Salud Rosario - Clínica del Tórax	Rosario
Argentina	Instituto de Oncologia de Rosario	Rosario
Argentina	Instituto Medico de la Fundacion Estudios Clinicos	Rosario
Argentina	Sanatorio Parque de Rosario	Rosario
Argentina	Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan	San Juan
Argentina	Centro Médico Privado de Reumatología	San Miguel de Tucuman
Argentina	Centro Medico San Roque	San Miguel de Tucuman
Argentina	Organizacion Medica de Investigacion	San Nicolás
Argentina	Centro de Investigación Clínica ? Clínica Viedma	Viedma
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	St Andrews Medical Centre	Adelaide	South Australia
Australia	Border Medical Oncology Research Unit	Albury	New South Wales
Australia	Wesley Medical Centre; Clinic For Haematology and Oncology	Auchenflower	Queensland
Australia	Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Bendigo Hospital	Bendigo	Victoria
Australia	Mater Cancer Care Centre	Brisbane	Queensland
Australia	Cairns Hospital; Renal Services	Cairns	Queensland
Australia	Campbelltown Hospital	Campbelltown	New South Wales
Australia	Northern Hospital	Epping	Victoria
Australia	Frankston Hospital; Oncology/Haematology	Frankston	Victoria
Australia	ICON Cancer Care Hobart	Hobart	Tasmania
Australia	Adelaide Cancer Centre	Kurralta Park	South Australia
Australia	Liverpool Hospital; Cancer Therapy Centre	Liverpool	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research	North Sydney	New South Wales
Australia	Westmead Hospital; Pharmacy Distribution Centre	Northmead	New South Wales
Australia	North Coast Cancer Institute - Port Macquarie	Port Macquarie	New South Wales
Australia	Maroondah Hospital; Breast Clinic	Ringwood East	Victoria
Australia	Goulburn Valley Health	Shepparton	Victoria
Australia	Sunshine Hospital	St Albans	Victoria
Australia	Townsville Hospital	Townsville	Queensland
Australia	South West Healthcare	Warrnambool	Victoria
Australia	Ballarat Oncology & Haematology	Wendouree	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	LKH-Universitätsklinikum Klinikum Graz	Graz
Austria	Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre	Innsbruck
Austria	Ordensklinikum Linz GmbH	Linz
Austria	LKH Rankweil, Interne E	Rankweil
Austria	Universitätsklinikum Salzburg	Salzburg
Austria	Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1	St. Pölten
Austria	A.ö. Krankenhaus der Barmherzigen Brüder	St. Veit
Austria	Oö. Gesundheits- und Spitals-AG/LKH Steyr	Steyr
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	Medizinische Universitat Wien Medical University of Vienna	Wien
Belgium	Institute Jules Bordet; Med Onc & Translational Rsch	Belgium
Belgium	Grand Hopital de Charleroi asbl	Charleroi
Belgium	UZ Leuven	Leuven
Belgium	CH de l'Ardenne (Libramont)	Libramont-Chevigny
Belgium	Chu Sart Tilman; Medical Oncology	Liege
Belgium	Centre Hospitalier Chrétien MontLégia	Liège
Belgium	CHR de la Citadelle, Pharmacie	Liège
Belgium	Clinique Sainte-Elisabeth; Oncologie	Namur
Belgium	Cliniques Universitaires UCL de Mont-Godinne	Namur
Belgium	GZA Ziekenhuizen Antwerpen campus Sint-Augustinus	Wilrijk
Bosnia and Herzegovina	Clinical Center Banja Luka	Banja Luka
Bosnia and Herzegovina	Clinical Hospital Mostar	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo; Oncology Institute	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla	Tuzla
Brazil	*X*Fundação Pio XII Hospital de Câncer de Barretos	Barretos	SP
Brazil	Cenantron - Centro Avancado de Tratamento Oncologico	Belo Horizonte	MG
Brazil	Oncoclinicas do Brasil Servicos Medicos As	Belo Horizonte	MG
Brazil	Centro de Pesquisas Clinicas em Oncologia - CPCO	Cachoeiro de Itapemirim	ES
Brazil	Universidade de Caxias do Sul - Rio Grande do Sul	Caxias do Sul	RS
Brazil	Hospital Araujo Jorge	Goiania	GO
Brazil	Hospital de Caridade de Ijui; Oncologia	Ijui	RS
Brazil	Clinica de Neoplasias Litoral	Itajai	SC
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital Bruno Born; Oncologia	Lajeado	RS
Brazil	Hospital São Vicente de Paulo X	Passo Fundo	RS
Brazil	Instituto de Oncologia Clínica de Piracicaba	Piracicaba	SP
Brazil	Hospital de Clinicas de Porto Alegre HCPA PPDS	Porto Alegre	PA
Brazil	Hospital Mae de Deus	Porto Alegre	RS
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS
Brazil	Hospital Nossa Senhora da Conceição; Ambulatório de Pneumologia	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Irmandade Da Santa Casa de Misericordia de Porto Alegre; Hospital Dom Vicente Scherer	Porto Alegre	RS
Brazil	Hospital do Cancer de Pernambuco - HCP	Recife	PE
Brazil	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ
Brazil	Centro Odonito Medico Linus Pauling - Clinica de O	Salvador	BA
Brazil	Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética	Salvador	BA
Brazil	Nucleo de Oncologia da Bahia - NOB	Salvador, Bahia	BA
Brazil	Centro de Oncologia da Bahia; Centro Médico Iguatemi	Salvador/BA	BA
Brazil	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	Sao Jose Do Rio Preto	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Brazil	Onco Star Sp Oncologia Ltda	Sao Paulo	SP
Brazil	Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda	São Paulo	SP
Brazil	Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia	São Paulo	SP
Brazil	Instituto de Oncologia de Sorocaba - CEPOS	Sorocaba	SP
Bulgaria	Complex Oncology Center Burgas; Medical Oncology Department	Burgas
Bulgaria	Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology	Panagyurishte
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay Lac Saint Jean	Chicoutimi	Quebec
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hopital Charles Le Moyne	Greenfield Park	Quebec
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	CHUM	Montreal	Quebec
Canada	CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont	Montreal	Quebec
Canada	McGill University Health Center	Montreal	Quebec
Canada	Sir Mortimer B Davis Jewish General Hospital	Montreal	Quebec
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	St-Jérome Medical Research, Inc.	Saint-Jerome	Quebec
Canada	Sault Area Hospital	Sault Ste. Marie	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Chile	IC La Serena Research SpA	La Serena
Chile	BIOCINETIC SpA	Peñalolen
Chile	Centro de Estudios Clínicos SAGA SpA	Providencia
Chile	Fundacion Arturo Lopez Perez; Quimioterapia	Providencia
Chile	Oncovida - Santiago	Providencia
Chile	Patagonia Research	Puerto Montt
Chile	Servicios Médicos URUMED SpA	Rancagua
Chile	Icegclinic	Santiago
Chile	Meditek Ltda	Santiago
Chile	Medwal	Santiago
Chile	Clinica Universidad Catolica del Maule	Talca
Chile	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco
Chile	ONCOCENTRO APYS; Oncología	Vina Del Mar
Chile	Centro de Investigaciones Clinicas Viña del Mar	Viña del Mar
China	Peking University People's Hospital	Beijing
China	Jilin Cancer Hospital	Changchun
China	The First Hospital of Jilin University	Changchun City
China	Hunan Cancer Hospital	Changsha CITY
China	West China Hospital, Sichuan University	Chengdu
China	The Second Affiliated Hospital of Dalian Medical University	Dalian
China	Fujian Provincial Cancer Hospital	Fuzhou City
China	Guangdong Provincial Maternity and Child Care Cent	Guangzhou
China	Sun yat-sen University Cancer Center; Internal Medicine of Oncology	Guangzhou
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou
China	Sir Run Run Shaw Hospital Zhejiang University	Hangzhou City
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Anhui Province Cancer Hospital	Hefei City
China	Jinan Central Hospital	Jinan City
China	Yunnan Cancer Hospital	Kunming
China	Linyishi Cancer Hospital	Linyi City
China	Jiangxi Cancer Hospital	Nanchang City
China	The Third Hospital of Nanchang	Nanchang City
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning City
China	The Second People's Hospital of Neijiang	Neijiang
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Shengjing Hospital of China Medical University	ShenYang
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Wenzhou Medical College - The First Affiliated Hospital GCP	Wenzhou City
China	Hubei Cancer Hospital	Wuhan
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	Air Force Military Medical University Xijing Hospital	Xi'an City
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Zhejiang Cancer Hospital	Zhejiang
China	Henan Cancer Hospital	Zhengzhou
Colombia	Hemato Oncólogos S.A	Cali
Colombia	FOSCAL	Floridablanca
Colombia	Oncomedica S.A.	Monteria
Colombia	Oncólogos Del Occidente SA	Pereira
Colombia	Sociedad de Oncología y hematología del Cesar Ltda	Valledupar
Costa Rica	Consultorio Oncologico-Hospital Metropolitano Linc	Moravia
Costa Rica	Instituto de Investigación en Ciencias Médicas S.A.	San Jose
Costa Rica	Centro de Cáncer y Hematología	San José
Costa Rica	Consultorio Oncologico-Hospital Metropolitano San	San José
Costa Rica	Oncotech S.A.	San José
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	General Hospital Pula	Pula
Croatia	University Hospital of Split	Split
Croatia	General Hospital Varazdin	Varazdin
Croatia	Clinical Hospital Sestre Milosrdnice	Zagreb
Croatia	Klinicki bolnicki centar Zagreb	Zagreb
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Czechia	Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni	Praha
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Fakultni nemocnice v Motole	Praha 5
Egypt	ALEXANDRIA UNI; Clinical Research Center	Alexandria
Egypt	Medical Technology Center for Research and Services	Alexandria
Egypt	Ain Shams University Hospital	Cairo
Egypt	Kasr Al Ainy School of Medicine-Cairo University	Cairo
Egypt	Sohag Oncology Center	Cairo
Egypt	Mansoura University Hospital	Dakahlia
Egypt	Dar ElSalam Cancer City	Old Cairo
Finland	Helsingin yliopistollinen keskussairaala	Helsinki
Finland	Tampereen yliopistollinen sairaala	Tampere
Finland	Turun Yliopistollinen Keskussairaala	Turku
France	Sas Clinique De L Europe - Amiens	Amiens
France	Hopital d'Argenteuil	Argenteuil
France	CHRU de Brest - Hopital Morvan	Brest
France	Centre Francois Baclesse	Caen
France	Institut Daniel Hollard	Grenoble
France	Centre Hospitalier Departemental de Vendee	La Roche Sur Yon
France	Centre Jean Bernard Clinique Victor Hugo	Le Mans
France	Centre Oscar Lambret	Lille
France	CHU Dupuytren	Limoges
France	Hôpital Privé Clairval	Marseille
France	Clinique Clémentville	Montpellier
France	Clinique Catherine de Sienne	Nantes
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Saint Louis	Paris
France	Hopital Tenon; AP HP	Paris
France	Hopital Universitaire Pitie Salpetriere	Paris
France	Institut Curie	Paris
France	Hopital privé des Côtes Armor	Plérin
France	EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS	Rennes Cedex
France	Centre Henri Becquerel	Rouen
France	Curie Saint Cloud	St Cloud
France	Institut de Cancérologie Strasbourg Europe	Strasbourg
France	Institut Gustave Roussy	Villejuif
Georgia	High Technology Hospital MedCenter Ltd	Batumi
Georgia	Acad. F. Todua Medical Center	Tbilisi
Georgia	Institute of Clinical Oncology LTD	Tbilisi
Georgia	LTD Health House	Tbilisi
Georgia	Ltd Israel-Georgia Medical Research Clinic Helsicore	Tbilisi
Georgia	LTD TIM, Tbilisi Institute of Medicine	Tbilisi
Georgia	Multiprofile Clinic Consilium Medulla	Tbilisi
Georgia	S Khechinashvili University Clinic Ltd	Tbilisi
Georgia	Tbilisi Oncology Dispensary	Tbilisi
Germany	Hämatologisch/onkologische Gemeinschaftspraxis; Dres. Brudler/Heinrich/Bangerter	Augsburg
Germany	Ambulantes Tumorzentrum Spandau	Berlin
Germany	Lübecker Onkologische Schwerpunktpraxis	Bonn
Germany	Marienhospital Bottrop	Bottrop
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	UNIVERSITATSKLINIKUM ERLANGEN; Department of Gynecology and Obstetrics	Erlangen
Germany	KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie	Essen
Germany	Franziskus-Hospital Harderberg	Georgsmarienhutte
Germany	SRH Wald-Klinikum Gera; Brustzentrum Ostthüringen	Gera
Germany	Mammazentrum Hamburg am Krankenhaus Jerusalem	Hamburg
Germany	Gynäkologisch Onkologische Praxis Hannover	Hannover
Germany	Vincentius-Diakonissen-Kliniken gAG	Karlsruhe
Germany	Facharztpraxis für Gynäkologie und Geburtshilfe PD Dr. med. Christian Kurbacher	Lübeck
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Klinikum Mannheim GmbH Universitätsklinikum	Mannheim
Germany	Praxis fuer gynaekologische onkologie Prof. Dr. me	Mönchengladbach
Germany	Hämatologie und Onkologie Ravensburg / Wangen	Ravensburg
Germany	Leopoldina Krankenhaus Schweinfurt	Schweinfurt
Germany	Praxis fur Haematologie und Internistische Onkologie	Velbert
Greece	General Oncology Hospital Kifissias "Oi Agioi Anargyroi"	Athens
Greece	Henry Dunant Hospital	Athens
Greece	Sotiria Chest Hospital of Athens	Athens
Greece	University of Athens Medical School - Regional General Hospital Alexandra	Athens
Greece	Aretaieio Hospital of Athens	Athina
Greece	Attikon University General Hospital	Chaidari
Greece	Metropolitan General Hospital	Cholargos
Greece	Metropolitan Hospital First Oncology Clinic	Faliro
Greece	Metropolitan Hospital Fourth Oncology Clinic	Faliro
Greece	University General Hospital of Heraklion	Heraklio
Greece	University General Hospital of Ioannina	Ioannina
Greece	University General Hospital of Larissa	Larissa
Greece	IASO Obstetrics Gynecology Clinic	Marousi
Greece	Medical Center of Athens	Marousi
Greece	Agios Loucas Clinic SA	Panorama
Greece	Olympion Clinic	Patras
Greece	University General Hospital of Patras	Patras
Greece	Bioclinic Thessaloniki	Thessaloniki
Greece	Euromedica PPDS	Thessaloniki
Greece	Interbalkan Medical Center of Thessaloniki	Thessaloniki
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki
Guatemala	Celan S.A.	Ciudad de Guatemala
Guatemala	Grupo Medico Angeles	Ciudad de Guatemala
Guatemala	INTEGRA Cancer Institute	Ciudad de Guatemala
Guatemala	Clínica Médica Especializada en Hematología	Guatemala
Guatemala	Oncomedica	Guatemala
Guatemala	Centro Medico Integral de Cancerologia CEMIC	Quetzaltenango
Hong Kong	Pamela Youde Nethersole Eastern Hospital; Department Of Pediatrics	Chai Wan
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong
Hungary	Budapesti Uzsoki Utcai Kórház	Budapest
Hungary	Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika	Budapest
Hungary	Tolna Megyei Balassa János Kórház	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Szent Borbala Korhaz	Tatabánya
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg
India	Gujarat Cancer & Research Inst.	Ahmadabad CITY	Gujarat
India	Sujan Surgical Cancer Hospital And Amravati Cancer Foundation	Amravati	Maharashtra
India	KLES Dr Prabhakar Kore Hospital and Medical Research Centre	Belagavi	Karnataka
India	All India Institute of Medical Sciences, Bhubaneswar	Bhubaneswar	Odisha
India	Erode Cancer Centre	Erode	Tamil NADU
India	Kolhapur Cancer Centre	Kolhapur	Maharashtra
India	Health Point Hospital - Kolkata	Kolkata	WEST Bengal
India	Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital	Kolkata	WEST Bengal
India	King George Medical University (KGMU)	Lucknow	Uttar Pradesh
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	Government Medical College	Nagpur	Maharashtra
India	HCG NCHRI Cancer Center	Nagpur	Maharashtra
India	Shalinitai Meghe Medical College and Hospital	Nagpur	Maharashtra
India	Apex Wellness Hospital	Nashik	Maharashtra
India	Chopda Medicare & Research Centre pvt. Ltd	Nashik	Maharashtra
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
India	State Cancer Institute, Indira Gandhi Institute of Medical Sciences (IGIMS)	Patna	Bihar
India	Lokmanya Holistic Cancer Care and Research Center (LMRC)	Pune	Maharashtra
India	Sahyadri Super Specialty Hospital Hadapsar	Pune	Maharashtra
India	Sahyadri Speciality Hospital	Pune City	Maharashtra
India	Christian Medical College-Ranipet Campus	Ratnagiri Kilminnal	Tamil NADU
India	Kiran Hospital Multi Super Speciality Hospital and Research Center	Surat	Gujarat
India	Nirmal Hospital	Surat	Gujarat
India	Himalaya Cancer Hospital & Research Institute	Vadodara	Gujarat
India	Kailash Cancer Hospital and Research Center	Vadodara	Gujarat
India	HCG City Cancer Centre	Vijayawada	Andhra Pradesh
Ireland	Bon Secours Hospital; Oncology	Cork
Ireland	Cork University Hospital	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	St Vincents University Hospital	Dublin
Ireland	Galway University Hospital	Galway
Ireland	Mid- Western Regional Hospital Limerick	Limerick
Ireland	Waterford Regional Hospital; Department Of Medical Oncology	Waterford
Israel	Shamir Medical Center Assaf Harofeh	Beer Jacob
Israel	Soroka University Medical Centre	Beer Sheva
Israel	Sheba Medical Center - PPDS	Ramat Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati	Avellino	Campania
Italy	Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola-Malpighi	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Careggi	Florence	Toscana
Italy	Ospedale Civile - Livorno	Livorno	Toscana
Italy	Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS	Meldola	Emilia-Romagna
Italy	ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda	Milano	Lombardia
Italy	Ospedale San Giuseppe; Oncologia Medica	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale	Napoli	Campania
Italy	IRCCS Ospedale Sacro Cuore Don Calabria	Negrar	Veneto
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	Toscana
Italy	Arcispedale Santa Maria Nuova; Oncologia	Reggio Emilia	Emilia-Romagna
Italy	Fondazione Policlinico Universitario A Gemelli; Farmacia Interna	Roma	Emilia-Romagna
Italy	Istituto Nazionale Tumori Regina Elena	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano (MI)	Lombardia
Italy	Azienda Ospedaliera Universitaria Senese	Siena	Abruzzo
Japan	St. Luke's International Hospital	Chuo
Japan	Hiroshima University Hospital	Hiroshima
Japan	National Hospital Organization Hokkaido Cancer Center	Hokkaido
Japan	Social Medical Corporation Hakuaikai Sagara Hospital	Kagoshima
Japan	Tokai University Hospital	Kanagawa
Japan	Kumamoto University Hospital	Kumamoto
Japan	Fukushima Medical University Hospital	Miyagi
Japan	Nahanishi Clinic	Naha-shi
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Saitama Cancer Center	Saitama
Japan	The Cancer Institute Hospital of Japanese Foundation For Cancer Research	Tokyo
Kenya	International Cancer Institute (ICI)	Eldoret
Kenya	Aga Khan University Hospital	Nairobi
Korea, Republic of	Chungbuk National University Hospital	Cheongju si
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Dongnam-gu, Cheonan-si
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Gangwon-do
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	National Cancer Centre	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary?s Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon City
Korea, Republic of	Ulsan University Hosiptal	Ulsan
Latvia	Pauls Stradins Clinical University Hospital	R?ga
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	FED. Territory OF Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur	FED. Territory OF Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Malaysia	Hospital Pulau Pinang	Penang
Malaysia	Beacon International Specialist Centre	Petaling Jaya, Selangor	Selangor
Malaysia	National Cancer Institute IKN	Putrajaya	Federal Territory OF Putrajaya
Malaysia	Pantai Hospital Sungai Petani	Sungai Petani	Kedah
Mexico	Centro de Investigacion Medica Aguascalientes	Aguascalientes
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	Neurociencias Estudios Clinicos S.C.	Culiacán	Sinaloa
Mexico	Office of Alma Magdalena Astorga-Ramos, MD	Gómez Palacio	Durango
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Clínica Integral Internacional de Oncología S de RL de CV	Heroica Puebla de Zaragoza	Puebla
Mexico	Unidad Médica Onco-Hematológica	Heroica Puebla de Zaragoza	Puebla
Mexico	Dr. José Luis González Trujillo	León de Los Aldama	Guanajuato
Mexico	Merida | Investigacion Clinica	Mérida	Yucatan
Mexico	Centro de Investigación en Artritis y Osteoporosis - PPDS	Mexicali	BAJA California
Mexico	Centro Oncologico Alianza XXI	Mexico
Mexico	Accelerium S. de R.L. de C.V.	Monterrey	Nuevo LEON
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo LEON
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca de Juárez	Oaxaca
Mexico	Oaxaca Site Management Organization	Oaxaca de Juárez	Oaxaca
Mexico	Oncológico Potosino	San Luis Potosí
Mexico	Investigación Médica de Alta Especialidad	Santiago de Querétaro	Queretaro
Mexico	Centro Hemato-Oncologico Privado CHOP	Toluca	Mexico CITY (federal District)
Netherlands	HAGAZIEKENHUIS; Interne Geneeskunde	'S-Gravenhage
Netherlands	Catharina Hospital; Research Oncologie	Eindhoven
Netherlands	Viecuri Medisch Centrum	Venlo
North Macedonia	PHI Clinical Hospital Dr Trifun Panovski Bitola	Bitola
North Macedonia	Acibadem Sistina Hospital	Skopje
North Macedonia	PHI University Clinic of Radiotherapy and Oncology; Breast malignancy	Skopje
Peru	Hospital Nacional Daniel A Carrion	Bellavista
Peru	Hospital Militar Central	Jesus Maria
Peru	Clínica Santa Beatriz	Lima
Peru	Hospital Central Fuerza Aerea Del Peru	Lima
Peru	Oncologia S.A.C. - Instituto Peruano de Oncología & Radioterapia	Lima
Peru	Oncosalud Sac; Oncología	Lima
Peru	Clinica Peruana Americana	Trujillo
Philippines	Dr Pablo O Torre Memorial Hospital	Bacolod City
Philippines	Baguio General Hospital and Medical Center	Baguio City
Philippines	Saint Louis University Hospital of Sacred Heart	Baguio City
Philippines	Metro Davao Medical and Research Center	Davao City
Philippines	St. Paul's Hospital	Iloilo City
Philippines	Cardinal Santos Medical Center; Department of Internal Medicine, Section of Endocrinology	Manila
Philippines	University of Santo Tomas Hospital; Pharmacy	Manila
Philippines	The Medical City; Oncology	Pasig City
Philippines	East Avenue Medical Center; Breast Care Center	Quezon City
Philippines	St. Luke's Medical Center - Quezon City	Quezon City
Poland	Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy	Bydgoszcz
Poland	Szpital Morski Im. Pck; Oncology & Radiotherapy Dept	Gdynia
Poland	Narodowy Instytut Onkologii im. M.Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy Oddzia? Gliwice	Gliwice
Poland	Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzia? Onkologii Klinicznej	Grudziadz
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii	Lublin
Poland	Centrum Medyczne Pratia Poznan	Skórzewo
Poland	Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie	Warszawa
Poland	Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy	Warszawa
Portugal	Hospital Senhora da Oliveira ? Guimaraes, E.P.E	Guimarães
Portugal	Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria; Servicos Farmaceuticos	Lisboa
Portugal	Champalimaud Cancer Center	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.	Lisbon
Portugal	Hospital Beatriz Angelo	Loures
Portugal	Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia	Porto
Portugal	Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E	Vila Nova de Gaia
Portugal	Centro Hospitalar Trás Os Montes E Alto Douro EPE	Vila Real
Romania	Spitalul Clinic de Obstetrica si Ginecologie Filantropia; Sectorul 1 BUCURE?TI	Bucure?ti
Romania	Medisprof SRL	Cluj-Napoca
Romania	Prof Dr I Chiricuta Institute of Oncology; Oncology Department	Cluj-napoca
Romania	Onco Clinic Consult SA	Craiova
Romania	Oncology Center Sf. Nectarie	Craiova
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Timisoara Emergency County Clinical Hospital	Timi?oara
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Serbia	Health Center Kladovo	Kladovo
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Serbia	General Hospital Djordje Joanovic - Zrenjanin	Zrenjanin
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	Onkologicky ustav sv. Alzbety, s.r.o.	Bratislava
Slovakia	Univerzitna nemocnica s poliklinikou Milosrdni bratia spol s r o	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav	Kosice
Slovenia	Institute of Oncology Ljubljana	Ljubljana
South Africa	Cancercare Rondebosch Oncology	Cape Town
South Africa	Cape Town Oncology Trials	Cape Town
South Africa	Sandton Oncology Medical Group (Pty) Ltd	City Of Johannesburg
South Africa	WITS Clinical Research Site PPDS	City Of Johannesburg
South Africa	Excellentis Clinical Trial Consultants; Clinical Research	George
South Africa	Medical Oncology Centre of Rosebank; Oncology	Johannesburg
South Africa	Langenhoven Drive Oncology Centre	Port Elizabeth
South Africa	Eastleigh Breast Care Centre	Pretoria
South Africa	Wilgers Oncology Centre	Pretoria
South Africa	Southern Cross Research South Africa (PTY) LTD	Randfontein
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital Universitario Fundación Alcorcón	Alcorcon	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario San Juan	Alicante
Spain	Hospital Nuestra Señora de Sonsoles	Avila
Spain	ICO Badalona-H.U. Germans Trias i Pujol	Badalona	Barcelona
Spain	Clinica Tres Torres	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Quiron Dexeus	Barcelona
Spain	Hospital Universitario Basurto	Bilbao	Vizcaya
Spain	Hospital de San Pedro de Alcantara	Caceres
Spain	Hospital Puerta del Mar	Cadiz
Spain	Consorcio Hospitalario Provincial de Castellon	Castellon DE LA Plana/castello DE LA Plana	Castellon
Spain	Hospital Universitario Reina Sofia; Servicio de Farmacia	Córdoba	Cordoba
Spain	Hospital Universitario A Coruña	Coruna	LA Coruña
Spain	Hospital Universitario de Donostia	Donostia	Guipuzcoa
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Institut Catala d'Oncologia Girona	Girona
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital Universitario de Jaen	Jaen
Spain	Hospital de Jerez	Jerez De La Frontera	Cadiz
Spain	Hospital Universitario Insular de Gran Canaria	Las Palmas de Gran Canaria	LAS Palmas
Spain	Hospital Universitari Arnau de Vilanova	Lleida	Lerida
Spain	Clinica Universidad Navarra; Servicio de Farmacia	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 De Octubre	Madrid
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz.	Madrid
Spain	Hospital Universitario HM Sanchinarro ? CIOCC; Farmacia - Ensayos Clínicos	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus	Madrid
Spain	MD Anderson Cancer Center Madrid ? Espana	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	ALTHAIA Xarxa Assistencial de Manresa	Manresa	Barcelona
Spain	Hospital General Universitario Morales Meseguer; Servicio de Neurología	Murcia
Spain	Hospital Universitario Virgen de La Arrixaca	Murcia
Spain	Hospital Son Llatzer	Palma de Mallorca	Islas Baleares
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Islas Baleares
Spain	Complejo Hospitalario de Navarra; Servicio de Farmacia	Pamplona	Navarra
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Universitario de Canarias	S. Cristobal De La Laguna	Tenerife
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	CHUS H Clinico U de Santiago	Santiago de Compostela	LA Coruña
Spain	Hospital HM Nuestra Señora de la Esperanza	Santiago de Compostela	Burgos
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Nuestra Senora de Valme	Seville	Sevilla
Spain	Hospital Universitario Virgen Macarena	Seville	Sevilla
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Fundacion Instituto Valenciano de Oncologia (IVO)	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Clinico Universitario de Valladolid; Servicio de Oncologia	Valladolid
Spain	CHUVI ? H.U. Alvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Länssjukhuset Ryhov	Jönköping
Sweden	Södersjukhuset	Stockholm
Sweden	Sundsvalls sjukhus	Sundsvall
Sweden	Akademiska Sjukhuset	Uppsala
Sweden	Västmanlands sjukhus Västerås	Västerås
Switzerland	Tumorzentrum Aarau; Hirslanden Medical Center	Aarau
Switzerland	Kantonsspital Baden	Baden
Switzerland	Universitätsspital Basel	Basel
Switzerland	Hirslanden Salem-Spital	Bern
Switzerland	Universitätsspital Bern; Departement Herz & Gefässe	Bern
Switzerland	Kantonsspital Graubünden KSGR; Onkologie/Hämatologie	Chur
Switzerland	Hirslanden Klinik St. Anna Brustzentrum/Chirurgie	Luzern
Switzerland	Luzerner Kantonsspital LUKS; Studienzentrale Onkologie	Luzern
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Spital STS AG Thun - Berner Oberland ; Onkologie Zentrum	Thun
Switzerland	Kantonsspital Winterthur Medizin Pneumologie	Winterthur
Switzerland	Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich	Zürich
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Beitou Dist.
Taiwan	Changhua Christian Medical Foundation Changhua Christian Hospital	Changhua County
Taiwan	Hsin-Chu Branch of National Taiwan University Hospital	Hsinchu City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chi Mei Medical Cente	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital - Taipei Branch	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan
Taiwan	Taichung Veterans General Hospital	Xitun Dist.
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok
Turkey	Ankara City Hospital; Oncology	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Istanbul University Cerrahpasa Medical Faculty Hospital; Klinik Arast?rma Merkezi	Istanbul
Turkey	T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Izmir Medical Point Hospital	Izmir
Turkey	Katip Celebi University- Izmir Ataturk Egitim ve Arastirma Hastanesi	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi	Kocaeli
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi	Samsun
Turkey	Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi	Sariçam
Turkey	Ac?badem Adana Hospital, Oncology Department	Seyhan/Adana
Turkey	Acibadem Altunizade Hospital	Üsküdar
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Yen?mahalle
Uganda	St Francis Hospital Nsambya	Kampala
Uganda	Uganda Cancer Institute	Kampala
Ukraine	Communal Non-Profit Enterprise Chernihiv Medical Center of Modern Oncology of CRC	Chernihiv	KIEV Governorate
Ukraine	Regional Municipal Non-Commercial Enterprise Bukovynian Clinical Oncology Center	Chernivtsi	KIEV Governorate
Ukraine	SI Institute for general and urgent surgery n.a. V.T.Zaitseva of NAMS of Ukraine	Kharkiv	Kharkiv Governorate
Ukraine	Clinic Verum Expert LLC	Kyiv	KIEV Governorate
Ukraine	Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center	Kyiv	KIEV Governorate
Ukraine	Kyiv Regional Oncological Dispensary	Kyiv
Ukraine	Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council	Odesa	Kherson Governorate
Ukraine	Medical Clinical Research Center of Medical Center LLC Health Clinic	Vinnytsia	Podolia Governorate
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	University College London Hospitals; Clinical Research Facility	London
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Royal Preston Hospital	Preston
United States	University Of Michigan	Ann Arbor	Michigan
United States	Messino Cancer Centers	Asheville	North Carolina
United States	CBCC Global Research Inc., at Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Hematology/Oncology Clinic, LLP	Baton Rouge	Louisiana
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	Aultman Hospital	Canton	Ohio
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University of Chicago Hospital	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Oncology Hematology Care Inc	Cincinnati	Ohio
United States	Cleveland Clinic; Taussig Cancer Institute	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Arrowhead Regional Medical Center	Colton	California
United States	Columbus NCORP	Columbus	Ohio
United States	SCRI Mark H. Zangmeister Center	Columbus	Ohio
United States	Stefanie Spielman Comprehensive Breast Center	Columbus	Ohio
United States	UPMC Western Maryland - Schwab Family Cancer Center	Cumberland	Maryland
United States	Southern Cancer Center	Daphne	Alabama
United States	Texas Oncology, P.A. - El Paso; West	El Paso	Texas
United States	Elmhurst Cancer Center	Elmhurst	Illinois
United States	Hunterdon Hematology Oncology	Flemington	New Jersey
United States	Texas Oncology (Flower Mound) - USOR	Flower Mound	Texas
United States	Nebraska Cancer Specialists	Fort Worth	Texas
United States	Texas Oncology-Fort Worth Cancer Center	Fort Worth	Texas
United States	Cancer and Blood Specialty Clinic	Fountain Valley	California
United States	Long Beach Memorial Medical Center	Fountain Valley	California
United States	University of Florida; UF Health Shands Cancer Hospital	Gainesville	Florida
United States	West Cancer Center & Research Institute	Germantown	Tennessee
United States	Pinnacle Health	Harrisburg	Pennsylvania
United States	Penn State Univ. Milton S. Hershey Medical Center; Department of Investigational Drug Services	Hershey	Pennsylvania
United States	Memorial Healthcare System - Memorial Regional Hospital	Hollywood	Florida
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Houston Methodist Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Baptist - MD Anderson Cancer Center	Jacksonville	Florida
United States	Joliet Oncology Hematology Associates, Ltd.	Joliet	Illinois
United States	University of Missouri-Columbia; Ellis Fischel Cancer Center	Kansas City	Missouri
United States	Cancer Center of Kansas - Kingman	Kingman	Kansas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Lahey Clinic Med Ctr	Lexington	Kentucky
United States	Massachusetts General Hospital; Lurie Center for Autism	Lexington	Massachusetts
United States	University of Kentucky; Markey Cancer Center	Lexington	Kentucky
United States	Rocky Mountain Cancer Centers (Longmont) - USOR	Longmont	Colorado
United States	Norton Cancer Institute - MDC	Louisville	Kentucky
United States	Joe Arrington Cancer Research & Treatment Center	Lubbock	Texas
United States	Lynchburg Hem Onc Clinic Inc	Lynchburg	Virginia
United States	University of Wisconsin	Madison	Wisconsin
United States	Texas Oncology (McAllen) - USOR	McAllen	Texas
United States	Texas Oncology McKinney	McKinney	Texas
United States	Miami Cancer Institute of Baptist Health, Inc.	Miami	Florida
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Bon Secours Mercy Health	Midlothian	Virginia
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	NYU Winthrop Hospital	Mineola	New York
United States	West Virginia University Hospitals Inc	Morgantown	West Virginia
United States	Edward Cancer Center Naperville	Naperville	Illinois
United States	Sarah Cannon Research Institute / Tennessee Oncology	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	New York University Cancer Cen	New York	New York
United States	Keck Medicine of USC ? Newport Beach	Newport Beach	California
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange	Orange	California
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	First Health of the Carolinas	Pinehurst	North Carolina
United States	Allegheny Cancer Center	Pittsburgh	Pennsylvania
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Edward Cancer Center Plainfield	Plainfield	Illinois
United States	Miami Cancer Institute-Plantation	Plantation	Florida
United States	Kaiser Permanente-Northwest Region	Portland	Oregon
United States	Women & Infants Hospital	Providence	Rhode Island
United States	Rex Cancer Center	Raleigh	North Carolina
United States	Virginia Commonwealth University - Massey Cancer Center	Richmond	Virginia
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg	Roanoke	Virginia
United States	UNC Cancer Care at Nash	Rocky Mount	North Carolina
United States	Kaiser Permanente - Roseville	Roseville	California
United States	Metro-Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	USOR - Texas Oncology - San Antonio Northeast	San Antonio	Texas
United States	Kaiser Permanente - San Diego	San Diego	California
United States	Kaiser Permanente - San Francisco (2238 Geary)	San Francisco	California
United States	Stanford Cancer Center South Bay	San Jose	California
United States	Sansum Clinic	Santa Barbara	California
United States	Kaiser Permanente - Santa Clara	Santa Clara	California
United States	UCLA Hematology/Oncology	Santa Monica	California
United States	St Joseph Heritage Healthcare	Santa Rosa	California
United States	Memorial Health University Cancer Center	Savannah	Georgia
United States	Swedish Cancer Institute; IDS Pharmacy	Seattle	Washington
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute	Springfield	Oregon
United States	Stamford Hospital; Clincal Trials Office - 1st Fl - Bennett Cancer Cente	Stamford	Connecticut
United States	Stony Brook Univ Cancer Ctr	Stony Brook	New York
United States	US Oncology Research, Inc.	The Woodlands	Texas
United States	Torrance Memorial Physician Network/Cancer Care	Torrance	California
United States	University of Maryland; St. Joseph Medical Center	Towson	Maryland
United States	Texas Oncology (Tyler) - USOR	Tyler	Texas
United States	Kaiser Permanente - Vallejo	Vallejo	California
United States	Valley Breast Care and Women's Health Center	Van Nuys	California
United States	Texas Oncology (Waco) - USOR	Waco	Texas
United States	Reading Hospital	West Reading	Pennsylvania
United States	UPMC Williamsport, Divine Providence Campus	Williamsport	Pennsylvania
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Costa Rica,  Croatia,  Czechia,  Egypt,  Finland,  France,  Georgia,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Kenya,  Korea, Republic of,  Latvia,  Malaysia,  Mexico,  Netherlands,  North Macedonia,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Uganda,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers		From randomization to first occurrence of an IDFS event (up to 10 years)
Secondary	Overall Survival		From randomization to death from any cause (up to 10 years)
Secondary	Invasive Disease-Free Survival (IDFS), Including Second Primary Non-Breast Cancers		From randomization to first occurrence of an IDFS event (up to 10 years)
Secondary	Disease-Free Survival (DFS)		From randomization to first occurrence of a DFS event (up to 10 years)
Secondary	Distant Recurrence-Free Interval (DRFI)		From randomization to first occurrence of a DFRI event (up to 10 years)
Secondary	Locoregional Recurrence-Free Interval (LRRFI)		From randomization to first occurrence of a LRRFI event (up to 10 years)
Secondary	Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Change from Baseline in the Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Change from Baseline in the Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Change from Baseline in the Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Change from Baseline in the EQ 5D-5L Index-Based Score at Specified Timepoints		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Change from Baseline in the EQ 5D-5L Visual Analogue Scale (VAS) Score at Specified Timepoints		Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary	Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)		From start of treatment until 28 days after the final dose of study treatment (up to 5 years)
Secondary	Plasma Concentrations of Giredestrant at Specified Timepoints		Predose and 3-4 hours postdose on Day 1 of Cycles 1 and 2, and predose on Day 1 of Cycles 3 and 6 (1 cycle is 28 days)
Secondary	Substudy: Incidence of Grade =3 Adverse Events with Giredestrant in Combination with Abemaciclib		From first dose of study treatment until 28 days after the last dose of treatment with the combination of giredestrant and abemaciclib or until the end of Year 2, whichever occurs first (up to 2 years)
Secondary	Substudy: Incidence and Severity of Adverse Events with Giredestrant in Combination with Abemaciclib, with Severity Determined According to NCI-CTCAE v5.0		From first dose of study treatment until 28 days after the last dose of treatment with the combination of giredestrant and abemaciclib or until the end of Year 2, whichever occurs first (up to 2 years)