Clinical trial NCT05296798: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Locally Advanced or Metastatic Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 922
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
* At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Left ventricular ejection fraction (LVEF) of at least (≥)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* Adequate hematologic and end-organ function
* For women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of Phesgo
* For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo

Maintenance Phase Inclusion Criteria

* Complete a minimum of four cycles to a maximum of eight cycles of induction therapy; the minimum cycles are defined as either: Phesgo injections + 4 docetaxel infusions, or Phesgo injections + 12 paclitaxel infusions
* Achieve a minimum of stable disease (SD) (or Non-complete response \[CR\]/Non-progressive disease \[PD\] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
* LVEF of ≥50% at the last assessment during the induction therapy phase

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
timeFrame: 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:
measure: Overall Survival
timeFrame: From randomization for maintenance therapy to death from any cause (up to 98 months)
measure: Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
timeFrame: From randomization for maintenance therapy to disease progression or death (up to 53 months)
measure: Duration of Response, as Determined by the Investigator According to RECIST v1.1
timeFrame: 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)
measure: Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
timeFrame: From randomization for maintenance therapy to disease progression or death (up to 53 months)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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)
timeFrame: From Baseline until 28 days after the final dose of study treatment (up to 8 years, 5 months)
measure: Number of Participants with Abnormalities in Clinical Laboratory Test Results
timeFrame: From Baseline until 28 days after the final dose of study treatment (up to 8 years, 5 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Grand Junction
country: United States
facility: St Mary's Hospital and Medical Center
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - EAST - SCRI - PPDS
state: Florida
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Annapolis
country: United States
facility: Maryland Oncology Hematology - Annapolis
state: Maryland
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Jamaica
country: United States
facility: Queens Hospital Cancer Center
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Corpus Christi
country: United States
facility: CHRISTUS Spohn Cancer Center - Shoreline
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - DFW
state: Texas
city: El Paso
country: United States
facility: Texas Oncology - El Paso
state: Texas
city: Houston
country: United States
facility: Millennium Physicians
state: Texas
city: Texarkana
country: United States
facility: CHRISTUS St. Michael Health System
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Edmonds
country: United States
facility: Swedish Cancer Institute - Edmonds Campus
state: Washington
city: Issaquah
country: United States
facility: Swedish Cancer Institute - Issaquah
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Oncologico Korben
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Mendoza
country: Argentina
facility: Fundacion Centro Oncologico de Integracion Regional (COIR)
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: GHdC Site Les Viviers
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - HSR
state: Bahia
city: Fortaleza
country: Brazil
facility: Pronutrir - suporte nutricional e quimioterapia ltda.
state: Ceará
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goiás
city: Londrina
country: Brazil
facility: Hospital do Câncer de Londrina
state: Paraná
city: Recife
country: Brazil
facility: Hospital do Cancer de Pernambuco - HCP
state: Pernambuco
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Porto Velho
country: Brazil
facility: Hospital de Amor Amazônia
state: Rondônia
city: Barretos
country: Brazil
facility: Fundação Pio XII Hospital de Câncer de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
state: São Paulo
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Peking University People's Hospital
city: Bengbu City
country: China
facility: the First Affiliated Hospital of Bengbu Medical College
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Changsha City
country: China
facility: Hunan Cancer Hospital
city: Chengdu City
country: China
facility: Sichuan Cancer Hospital
city: Chengdu City
country: China
facility: West China Hospital - Sichuan University
city: Fuzhou City
country: China
facility: No. 900 Hospital (Fuzhou General Hospital)
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Provincial People?s Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Jinzhou City
country: China
facility: The First Affiliated Hospital Of Jinzhou Medical University
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Nanchang City
country: China
facility: The Third Hospital of Nanchang
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Nanning City
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Shenyang City
country: China
facility: The First Affiliated Hospital of China Medical University
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Urumqi
country: China
facility: The Tumor Hospital of Xinjiang Medical University
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Xi'an City
country: China
facility: The First Affiliated Hospital of Xian Jiao Tong University
city: Barranquilla
country: Colombia
facility: Clinica De La Costa
city: Bogota, D.C.
country: Colombia
facility: Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Pereira
country: Colombia
facility: Oncólogos de Occidente
city: Cairo
country: Egypt
facility: Dar El salam Cancer Centre
city: Cairo
country: Egypt
facility: National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement
city: Cairo
country: Egypt
facility: Sohag Oncology Center
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: CH de la Côte Basque - Hôpital de Bayonne
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Grenoble
country: France
facility: CHU de GRENOBLE
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Paris
country: France
facility: INSTITUT CURIE_Site Paris
city: Perpignan
country: France
facility: Centre Catalan D' Oncologie
city: Poitiers
country: France
facility: CHU Poitiers
city: Bad Nauheim
country: Germany
facility: Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Bonn
country: Germany
facility: Gynäkologisches Zentrum Bonn
city: Dresden
country: Germany
facility: Onkozentrum Dres. Göhler
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: HOPA MVZ GmbH
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT)
city: Hildesheim
country: Germany
facility: Ärztehaus am Bahnhofsplatz
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Langen
country: Germany
facility: Dres. Andreas Köhler und Roswitha Fuchs
city: Ravensburg
country: Germany
facility: MVZ für Hämatologie und Onkologie Ravensburg GmBH
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Budapest
country: Hungary
facility: Budapesti Szent Margit Korhaz
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz
city: Budapest
country: Hungary
facility: Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
city: Gyula
country: Hungary
facility: Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Tatabanya
country: Hungary
facility: Komarom-Eszergom Varmegyei Szent Borbala Korhaz
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center
state: Delhi
city: New Delhi
country: India
facility: Fortis Hospital
state: Delhi
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Specialty Hospital Hadapsar
state: Maharashtra
city: Kolkata
country: India
facility: Netaji Subhas Chandra Bose Cancer Hospital
state: WEST Bengal
city: Kolkata
country: India
facility: TATA Medical Centre
state: WEST Bengal
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
state: Campania
city: Ravenna
country: Italy
facility: AUSL della Romagna
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi AUSL della Romagna
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Misterbianco (CT)
country: Italy
facility: Humanitas Centro Catanese Di Oncologia
state: Sicilia
city: Livorno
country: Italy
facility: Ospedale Civile
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Amman
country: Jordan
facility: King Hussein Cancer Center
city: Eldoret
country: Kenya
facility: International Cancer Institute (ICI)
city: Nairobi
country: Kenya
facility: Aga Khan University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Beirut
country: Lebanon
facility: Rizk Hospital
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
city: Jbeil
country: Lebanon
facility: Notre Dame Des Secours Hospital
city: La Paz
country: Mexico
facility: Investigacion Oncofarmaceutica
state: BAJA California SUR
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: D.f.
country: Mexico
facility: Iem-Fucam
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Filios Alta Medicina
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Hospital Universitario
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Hospital Zambrano Hellion TecSalud
state: Nuevo LEON
city: Querétaro
country: Mexico
facility: Cuidados oncologicos
state: Queretaro
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
state: SAN LUIS Potosi
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia de Chihuahua
city: Muscat
country: Oman
facility: Sultan Qaboos Comprehensive Cancer Care & Research Center
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Gdynia
country: Poland
facility: Szpital Morski im.PCK
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED, Roman Karaszewski
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Miko?aja Kopernika
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii
city: Pi?a
country: Poland
facility: Ars Medical Sp. z o. o.
city: Pozna?
country: Poland
facility: Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
city: Rzeszow
country: Poland
facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
city: Warszawa
country: Poland
facility: Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
city: Coimbra
country: Portugal
facility: IPO de Coimbra
city: Lisboa
country: Portugal
facility: Hospital de S. Francisco Xavier
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Porto
country: Portugal
facility: IPO do Porto
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
city: Riyadh
country: Saudi Arabia
facility: National Guard King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Parktown, Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Centre
city: Pretoria
country: South Africa
facility: University of Pretoria Oncology Department
city: Pretoria
country: South Africa
facility: Eastleigh Breast Care Centre
city: Sant Andreu de La Barca
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO), Barcelona
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
state: LA Coruna
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei 100
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital Office of General Surgery
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Adana
country: Turkey
facility: Adana Baskent University Hospital
city: Ankara
country: Turkey
facility: Ankara Oncology Hospital
city: Ankara
country: Turkey
facility: Gazi Uni Medical Faculty Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Bursa
country: Turkey
facility: Uludag Uni Hospital
city: Diyarbakir
country: Turkey
facility: Dicle University Faculty of Medicine
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
city: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
city: Istanbul
country: Turkey
facility: Ac?badem Altunizade Hastanesi
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty
city: Izmir
country: Turkey
facility: Katip Celebi University Ataturk Training and Research Hospital
city: Izmit
country: Turkey
facility: Kocaeli University Faculty of Medicine
city: Kayseri
country: Turkey
facility: Erciyes Uni
city: Kepez
country: Turkey
facility: Antalya Memorial Hastanesi
city: Mersin
country: Turkey
facility: Mersin City Education and Research Hospital
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.
city: Sar?yer/?stanbul
country: Turkey
facility: Ac?badem Maslak Hastanesi Büyükdere
city: Seyhan
country: Turkey
facility: Medical Park Seyhan Hospital
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital
city: Tekirdag
country: Turkey
facility: Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical University Medical Faculty
city: Kampala
country: Uganda
facility: Uganda Cancer Institute
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Medical City-Abu Dhabi
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Cleveland
country: United Kingdom
facility: University Hospital North Tees
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - City Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hosp
city: Rhyl
country: United Kingdom
facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: