Trial Title:
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
NCT ID:
NCT05894239
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Taxane
Inavolisib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Inavolisib
Description:
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD),
on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance
treatment.
Arm group label:
Maintenance Therapy: Inavolisib plus Phesgo
Intervention type:
Drug
Intervention name:
Phesgo
Description:
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of
each 21-day cycle.
Arm group label:
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Arm group label:
Maintenance Therapy: Inavolisib plus Phesgo
Arm group label:
Maintenance Therapy: Placebo plus Phesgo
Intervention type:
Drug
Intervention name:
Placebo
Description:
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1
C1 of maintenance treatment.
Arm group label:
Maintenance Therapy: Placebo plus Phesgo
Intervention type:
Drug
Intervention name:
Taxane-based Chemotherapy
Description:
During the induction therapy phase, the investigator's choice of taxane-based
chemotherapy will be administered after Phesgo.
Arm group label:
Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
Other name:
non-investigational medicinal product (NIMP)
Intervention type:
Drug
Intervention name:
Optional Endocrine Therapy of Investigator's Choice
Description:
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based
on the standard of care. Allowed ETs are tamoxifen, or one of the specified
third-generation aromatase inhibitor (AI [anastrozole, letrozole, or exemestane]), or
fulvestrant. The investigator will determine and supply the appropriate luteinizing
hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The
LHRH agonist will be administered according to local prescribing information.
Arm group label:
Maintenance Therapy: Inavolisib plus Phesgo
Arm group label:
Maintenance Therapy: Placebo plus Phesgo
Other name:
NIMP
Summary:
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo
(pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with
placebo in combination with Phesgo, as maintenance therapy, after induction therapy in
participants with previously untreated HER2-positive advanced breast cancer (ABC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Histologically or cytologically confirmed and documented adenocarcinoma of the
breast with metastatic or locally advanced disease not amenable to curative
resection
- Confirmation of HER2 biomarker eligibility based on valid results from central
testing of tumor tissue documenting HER2-positivity
- Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from
central testing of tumor tissue documenting PIK3CA-mutated tumor status
- Disease-free interval from completion of adjuvant or neoadjuvant systemic
non-hormonal treatment to recurrence of >= 6 months
- LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram
(ECHO) or multiple-gated acquisition scan (MUGA)
- Adequate hematologic and organ function prior to initiation of study treatment
Exclusion Criteria:
- Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or
mTOR inhibitor or any agent whose mechanism of action is to inhibit the
PI3K-AKT-mTOR pathway
- Any prior systemic non-hormonal anti-cancer therapy for locally advanced or
metastatic HER2-positive breast cancer prior to initiation of induction therapy
- History or active inflammatory bowel disease
- Disease progression within 6 months of receiving any HER2-targeted therapy
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or
any history of Type 1 diabetes
- Participants with active HBV infection
- Clinically significant and active liver disease, including severe liver impairment,
viral or other hepatitis, current alcohol abuse, or cirrhosis
- Symptomatic active lung disease, including pneumonitis or interstitial lung disease
- Any history of leptomeningeal disease or carcinomatous meningitis
- Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
- Any concurrent ocular or intraocular condition that, in the opinion of the
investigator, would require medical or surgical intervention during the study period
to prevent or treat vision loss that might result from that condition
- Active inflammatory or infectious conditions in either eye or history of idiopathic
or autoimmune-associated uveitis in either eye
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner Health MD Anderson AZ
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Disney Family Cancer Center
Address:
City:
Burbank
Zip:
91505
Country:
United States
Status:
Recruiting
Facility:
Name:
Lawrence J. Ellison Institute for Transformative Medicine
Address:
City:
Los Angeles
Zip:
90064
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgetown Uni Hospital; 4-N Main Hospital
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
Medstar Research Institute
Address:
City:
Hyattsville
Zip:
20783
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Atrium Health
Address:
City:
Charlotte
Zip:
28209
Country:
United States
Status:
Recruiting
Facility:
Name:
Hightower Clinical
Address:
City:
Oklahoma City
Zip:
73102
Country:
United States
Status:
Recruiting
Facility:
Name:
Lumi Research
Address:
City:
Kingwood
Zip:
77339
Country:
United States
Status:
Withdrawn
Facility:
Name:
Kadlec Clinic Hematology and Oncology
Address:
City:
Kennewick
Zip:
99336-7774
Country:
United States
Status:
Recruiting
Facility:
Name:
Swedish Medical Center
Address:
City:
Seattle
Zip:
98104-1360
Country:
United States
Status:
Recruiting
Facility:
Name:
Fundación CENIT para la Investigación en Neurociencias
Address:
City:
Buenos Aires
Zip:
C1125ABD
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
Centro Oncologico Korben; Oncology
Address:
City:
Ciudad Autonoma Buenos Aires
Zip:
C1426AGE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Instituto de Oncología de Rosario
Address:
City:
Rosario
Zip:
S2000KZE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Provincial del Centenario
Address:
City:
Rosario
Zip:
S2002KDS
Country:
Argentina
Status:
Recruiting
Facility:
Name:
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
Address:
City:
San Juan
Zip:
J5400DIL
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Clínica Viedma
Address:
City:
Viedma Rio Negro
Zip:
R8500ACE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Blacktown Hospital
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Kinghorn Cancer Centre; St Vincents Hospital
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Gosford Hospital; Cancer Care Services
Address:
City:
Gosford
Zip:
2250
Country:
Australia
Status:
Recruiting
Facility:
Name:
University of the Sunshine Coast
Address:
City:
Sippy Downs
Zip:
4556
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sir Charles Gairdner Hospital; Medical Oncology
Address:
City:
Perth
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires St-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
GHdC Site Notre Dame
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Jessa Zkh (Campus Virga Jesse)
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Clinique Ste-Elisabeth
Address:
City:
Namur
Zip:
5000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Hospital Sao Rafael - HSR
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Crio - Centro Regional Integrado de Oncologia
Address:
City:
Fortaleza
Zip:
60336-232
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Address:
City:
Goiania
Zip:
74605-070
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital do Cancer de Pernambuco - HCP
Address:
City:
Recife
Zip:
50040-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital do Câncer de Londrina
Address:
City:
Londrina
Zip:
86015-520
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Amor Amazônia
Address:
City:
Porto Velho
Zip:
76834-899
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Santa Casa de Misericordia de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90020-090
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Hospital Sao Lucas - PUCRS
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo - ICESP
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Address:
City:
Sao Paulo
Zip:
01317-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Tom Baker Cancer Centre-Calgary
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Moncton Hospital
Address:
City:
Moncton
Zip:
E1C 6Z8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Eastern Health - General Hospital
Address:
City:
St. John's
Zip:
A1B 3V6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Hôpital du Sacré-Coeur de Montreal
Address:
City:
Montreal
Zip:
H4J 1C5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Hopital du Saint Sacrement
Address:
City:
Quebec City
Zip:
G1S 4L8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Allan Blair Cancer Center
Address:
City:
Regina
Zip:
S4T 7T1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Hebei University; Department of medical oncology
Address:
City:
Baoding
Zip:
071000
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun City
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Provincial Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Zip:
610072
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou City
Zip:
310009
Country:
China
Status:
Withdrawn
Facility:
Name:
Zhejiang Cancer Hospital; Breast Surgery
Address:
City:
Hangzhou City
Zip:
310022
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
Address:
City:
Harbin
Zip:
150049
Country:
China
Status:
Recruiting
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital to Henan University of Science and Technology
Address:
City:
Luoyang City
Zip:
471031
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital to Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning City
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Shantou Center Hospital
Address:
City:
Shantou City
Zip:
515031
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Cancer Hospital; Department of Breast Oncology
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan City
Zip:
430023
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Clinica De La Costa
Address:
City:
Barranquilla
Zip:
080020
Country:
Colombia
Status:
Completed
Facility:
Name:
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Address:
City:
Bogota, D.C.
Zip:
110131
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Oncomedica S.A.
Address:
City:
Monteria
Zip:
230002
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Tampere University Hospital; Dept of Oncology
Address:
City:
Tampere
Zip:
33520
Country:
Finland
Status:
Recruiting
Facility:
Name:
Turku Uni Central Hospital; Oncology Clinics
Address:
City:
Turku
Zip:
20520
Country:
Finland
Status:
Recruiting
Facility:
Name:
Institut Sainte Catherine
Address:
City:
Avignon
Zip:
84082
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier de La Cote Basque; Oncologie
Address:
City:
Bayonne
Zip:
64109
Country:
France
Status:
Recruiting
Facility:
Name:
Polyclinique Bordeaux Nord Aquitaine
Address:
City:
Bordeaux
Zip:
33300
Country:
France
Status:
Recruiting
Facility:
Name:
Klinikum St. Marien; Frauenklinik
Address:
City:
Amberg
Zip:
92224
Country:
Germany
Status:
Recruiting
Facility:
Name:
Marienhospital Bottrop gGmbH; Department of Gynecology and Obstetrics
Address:
City:
Bottrop
Zip:
46236
Country:
Germany
Status:
Recruiting
Facility:
Name:
Gynonco Düsseldorf, MVZ Medical Center GmbH
Address:
City:
Düsseldorf
Zip:
40235
Country:
Germany
Status:
Recruiting
Facility:
Name:
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Address:
City:
Erfurt
Zip:
99084
Country:
Germany
Status:
Recruiting
Facility:
Name:
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Address:
City:
Freiburg
Zip:
79110
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
Address:
City:
München
Zip:
80336
Country:
Germany
Status:
Recruiting
Facility:
Name:
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Address:
City:
Saarbruecken
Zip:
66113
Country:
Germany
Status:
Recruiting
Facility:
Name:
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Address:
City:
Stralsund
Zip:
18439
Country:
Germany
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital; Dept. of Clinical Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Tuen Mun Hospital; Clinical Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Max Super Speciality Hospital; Oncology
Address:
City:
NEW Delhi Delhi
Zip:
110092
Country:
India
Status:
Recruiting
Facility:
Name:
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
Address:
City:
Surat CITY
Zip:
395007
Country:
India
Status:
Recruiting
Facility:
Name:
Artemis Hospital
Address:
City:
Gurugram
Zip:
122001
Country:
India
Status:
Recruiting
Facility:
Name:
Tata Medical Center
Address:
City:
Kolkata
Zip:
700160
Country:
India
Status:
Recruiting
Facility:
Name:
I.R.S.T Srl IRCCS; Oncologia Medica
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Giovanni Addolorata; Oncologia
Address:
City:
Roma
Zip:
00185
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele; Medical Oncology
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Gerardo; Centro Di Ricerca di Fase I ? Piano 8 ? Settore C
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U. Maggiore della Carità
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Casa di Cura La Maddalena; Oncologia Medica
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Maria Annunziata; Oncologia
Address:
City:
Bagno a Ripoli
Zip:
50012
Country:
Italy
Status:
Recruiting
Facility:
Name:
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
Address:
City:
Verona
Zip:
37124
Country:
Italy
Status:
Recruiting
Facility:
Name:
King Hussein Cancer Center
Address:
City:
Amman
Zip:
11941
Country:
Jordan
Status:
Recruiting
Facility:
Name:
University of Nairobi - Institute of Tropical and Infectious Diseases
Address:
City:
Nairobi
Zip:
19676-00202
Country:
Kenya
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Zip:
06273
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul St Mary's Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hospital Civil de Guadalajara Fray Antonio Alcalde
Address:
City:
Guadalajara
Zip:
44280
Country:
Mexico
Status:
Recruiting
Facility:
Name:
OncoMed; Supportive Care
Address:
City:
Ciudad de México
Zip:
03100
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centro Oncológico Hematológico Roma
Address:
City:
Mexico City
Zip:
06700
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Hospital Universitario; Dr. Jose E. Gonzalez
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Hospital Zambrano Hellion TecSalud
Address:
City:
Monterrey
Zip:
66278
Country:
Mexico
Status:
Withdrawn
Facility:
Name:
CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
Address:
City:
Mexico City
Zip:
03100
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Recruiting
Facility:
Name:
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Facility:
Name:
Przychodnia Lekarska KOMED, Roman Karaszewski
Address:
City:
Konin
Zip:
62-500
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Facility:
Name:
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Status:
Recruiting
Facility:
Name:
National Cancer Centre; Medical Oncology
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Active, not recruiting
Facility:
Name:
Icon Cancer Centre Farrer Park
Address:
City:
Singapore
Zip:
217562
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Tan Tock Seng Hospital; Oncology
Address:
City:
Singapore
Zip:
308433
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Hopelands Cancer Centre
Address:
City:
Hilton
Zip:
3245
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Charlotte Maxeke Academic Hospital
Address:
City:
Johannesburg
Zip:
2193
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Medical Oncology Centre of Rosebank; Oncology
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Limpopo Cancer Research Institute
Address:
City:
Polokwane
Zip:
0700
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Steve Biko Academic Hospital; Oncology
Address:
City:
Pretoria
Zip:
0002
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Chris Hani Baragwanath Clinical Trial Site
Address:
City:
Soweto
Zip:
2013
Country:
South Africa
Status:
Active, not recruiting
Facility:
Name:
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Ramon y Cajal; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
National Taiwan Uni Hospital; General Surgery
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Tri-Service General Hospital; Department of Haematology and Oncology
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
Address:
City:
Taoyuan County
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Gazi University Medical Faculty
Address:
City:
Ankara
Zip:
06500
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Address:
City:
Bakirkoy / Istanbul
Zip:
34147
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Dicle University Faculty of Medicine
Address:
City:
Diyarbakir
Zip:
21280
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Medipol Mega Üniversite Hastanesi Göztepe
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Katip Celebi University Ataturk Training and Research Hospital; Oncology
Address:
City:
Izmir
Zip:
35360
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Medical Park Seyhan Hospital; Oncology Department
Address:
City:
Seyhan
Zip:
01140
Country:
Turkey
Status:
Active, not recruiting
Facility:
Name:
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Address:
City:
Sihhiye/Ankara
Zip:
06230
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Blackpool Victoria Hospital
Address:
City:
Blackpool
Zip:
FY3 8NR
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Colchester General Hospital
Address:
City:
Colchester, Essex
Zip:
CO4 5JL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Mount Vernon Hospital; Centre For Cancer Treatment
Address:
City:
Northwood
Zip:
HA6 2RN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Nottingham City Hospital; Oncology
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Churchill Hospital; Oxford Cancer and Haematology Centre
Address:
City:
Oxford
Zip:
OX3 7LJ
Country:
United Kingdom
Status:
Recruiting
Start date:
July 28, 2023
Completion date:
October 31, 2028
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05894239
