Clinical trial NCT04177108: A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Official title: A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Triple-Negative Breast Cancer
Keywords: Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Atezolizumab
Ipatasertib
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 242
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 study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.


Eligibility criteria: Inclusion Criteria:

1. Willingness and ability to complete all study-related assessments, including Participant-Reported Outcome (PRO) assessments, in the investigator's judgement.
2. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
3. Life expectancy of at least 6 months.
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
8. Appropriate candidate for paclitaxel monotherapy if tumor programmed death-ligand 1 (PD-L1) status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
9. Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.

Exclusion Criteria:

1. Inability to comply with study and follow-up procedures.
2. History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
3. Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
4. Known human immunodeficiency virus (HIV) infection (there must be a negative HIV test at screening).
5. Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
6. Current treatment with anti-viral therapy for hepatitis B virus (HBV).
7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
8. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib or (/) placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
9. New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction less than (\<) 50 percent (%), or active ventricular arrhythmia requiring medication.
10. Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
11. Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) greater than (\>) 480 milliseconds (ms).
12. Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
13. History or presence of an abnormal ECG that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction).
14. Requirement for chronic corticosteroid therapy of \> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
15. Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
16. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications.
17. History of or known presence of spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments.
18. Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases.
19. Known germline breast cancer gene (BRCA)1/2 deleterious mutation, unless the participant is not an appropriate candidate for a poly adenosine diphosphate ribose polymerase (PARP)-inhibitor.
20. Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
21. Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
22. Participants who have received palliative radiotherapy to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrolment).
23. Uncontrolled pleural effusion, pericardial effusion or ascites.
24. Uncontrolled tumor-related pain.
25. Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
26. Known hypersensitivity or contraindication to any component of the study treatments, including the paclitaxel excipient, macrogolglycerol ricinoleate.
27. Grade greater than or equal to (≥) 2 peripheral neuropathy.
28. History of Type I or Type II diabetes mellitus requiring insulin.
29. Grade ≥ 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
30. History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
31. Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
32. Treatment with strong Cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
33. Prior treatment with an Protein kinase B (Akt) inhibitor.
34. Active or history of autoimmune disease or immune deficiency.
35. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
36. Prior allogeneic stem cell or solid organ transplantation.
37. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the final dose of atezolizumab.
38. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
39. Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
40. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
41. Treatment with systemic immunosuppressive medication (including, but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study.

Primary outcomes:
measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: From Randomization to disease progression, study completion, or death (up to 39 months)
measure: Overall Survival (OS)
timeFrame: From randomization up to study completion or death (Up to 39 months)
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 39 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Mitchell Cancer Institute
state: Alabama
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Diego
country: United States
facility: Kaiser Permanente-SCPMG; Oncology Research
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Kaiser Permanente - Franklin
state: Colorado
city: Stamford
country: United States
facility: Stamford Hospital; BCC, MOHR
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System - Memorial Regional Hospital
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial West
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Savannah
country: United States
facility: Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Medstar Franklin Square Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital; Cancer Care Center.
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Grand Island
country: United States
facility: CHI Health Saint Francis; Oncology
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Portland
country: United States
facility: Kaiser Permanente - Portland
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Charleston Oncology, P .A
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System; Cancer Center
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic; West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ Medical Ctr
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Buenos Aires
country: Argentina
facility: Inst. Angel Roffo; Haematology
city: Ciudad Autonoma Bs As
country: Argentina
facility: Hospital Britanico
city: Cordoba
country: Argentina
facility: Instituto Medico Rio Cuarto
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (CORI)
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: Mid North Coast Cancer Institute
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital; Department of Medical Oncology
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Health Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre; Medical Oncology
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital; Oncology Research
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Hospital; Bendat Cancer Centre
state: Western Australia
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - HSR
state: BA
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
state: SP
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
state: SP
city: Sofia
country: Bulgaria
facility: MHAT Nadezhda
city: Edmonton
country: Canada
facility: Cross Cancer Institute ; Dept of Medical Oncology
state: Alberta
city: Surrey
country: Canada
facility: Fraser Valley Centre British Columbia Cancer Agency
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Glen Site; Oncology
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital; Research Unit
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Bogota
country: Colombia
facility: Clinica del Country
city: Pereira
country: Colombia
facility: Oncólogos de Occidente
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: Brno
country: Czechia
facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Herlev
country: Denmark
facility: Herlev Hospital; Afdeling for Kræftbehandling
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Helsinki
country: Finland
facility: Docrates Cance Center
city: Kuopio
country: Finland
facility: KYS Sadesairaala; Syopatautien poliklinikka
city: Vaasa
country: Finland
facility: VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
city: Rennes
country: France
facility: Centre Eugene Marquis; Service d'oncologie
city: Kifisia
country: Greece
facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Dept of Medicine
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital; Clinical Onc
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital; Department of Clinical Onocology
city: Pune
country: India
facility: Sahyadri Super Specialty Hospital Hadapsar
state: Maharashtra
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Napoli
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Udine
country: Italy
facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia
state: Friuli-Venezia Giulia
city: Brescia
country: Italy
facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
state: Lombardia
city: Lecco
country: Italy
facility: ASST DI LECCO; Oncologia Medica
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: IRCCS Istituto Clinico Humanitas; Oncologia
state: Lombardia
city: Livorno
country: Italy
facility: Ospedale Civile; Unita Operativa Di Oncologia Medica
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gunma
country: Japan
facility: Gunma Prefectural Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
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: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: La Paz
country: Mexico
facility: Investigacion Oncofarmaceutica
state: BAJA California SUR
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera
state: Nuevo LEON
city: Auckland
country: New Zealand
facility: Auckland City Hospital, Cancer and Blood Research
city: Tauranga
country: New Zealand
facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
city: Wellington
country: New Zealand
facility: Wellington Regional Hospital; Clinical Trials Unit
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Arequipa
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion
city: Lima
country: Peru
facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
city: Lima
country: Peru
facility: Hospital Arzobispo Loayza
city: Lima
country: Peru
facility: Oncosalud Sac; Oncología
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma
city: ?ód?
country: Poland
facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
city: Gliwice
country: Poland
facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
city: Lisboa
country: Portugal
facility: Hospital da Luz; Departamento de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo; Departamento de Oncologia
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
state: Arhangelsk
city: Moscow
country: Russian Federation
facility: University ?linic of headaches
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
state: Moskovskaja Oblast
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
state: Tatarstan
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company "RC Medical"
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Bloemfontein
country: South Africa
facility: National Hospital; Oncotherapy Dept
city: George
country: South Africa
facility: Cancercare
city: Johannesberg
country: South Africa
facility: Wits Clinical Research
city: Port Elizabeth
country: South Africa
facility: Cancercare
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: Castellon de La Plana
country: Spain
facility: Hospital Provincial de Castellon; Servicio de Oncologia
state: Castellon
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
state: LA Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Surgery
city: Taipei
country: Taiwan
facility: VETERANS GENERAL HOSPITAL; Department of General Surgery
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; General Surgery
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hosipital at Linkou
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Medical Oncology
city: Bangkok
country: Thailand
facility: Rajavithi Hospital; Division of Medical Oncology
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
city: Khonkaen
country: Thailand
facility: Khonkaen Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Oncology
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty; Oncology Department
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Kharkiv
country: Ukraine
facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
state: Kharkiv Governorate
city: Chernigiv
country: Ukraine
facility: Regional Oncology Center; Department of Mammology
city: Dnipropetrovsk
country: Ukraine
facility: Chemotherapy SI Dnipropetrovsk MA of MOHU
city: Kryvyi Rih
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
city: Kyiv
country: Ukraine
facility: MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Sumy
country: Ukraine
facility: RCI Sumy Regional Clinical Oncological Dispensary
city: Glasgow
country: United Kingdom
facility: BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1
city: London
country: United Kingdom
facility: The Royal Marsden Hospital, Fulham
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: