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JOURNAL ONKOLOGIE – STUDIE

IPATunity130 A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Rekrutierend

NCT-Nummer:
NCT03337724

Studienbeginn:
Januar 2018

Letztes Update:
20.03.2020

Wirkstoff:
Ipatasertib, Placebo, Paclitaxel

Indikation (Clinical Trials):
Breast Neoplasms, Triple Negative Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID: CO40016 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. only)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations (3 von 239)

Onkologische Schwerpunktpraxis Kurfürstendamm
10707 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
79110 Freiburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
20246 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
66424 Homburg/Saar
(Saarland)
GermanyRekrutierend» Google-Maps
Praxis Dr.med. Katja Ziegler-Löhr
50679 Köln
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Dres. Andreas Köhler und Roswitha Fuchs
63225 Langen
(Hessen)
GermanyRekrutierend» Google-Maps
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
32429 Minden
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
18059 Rostock
(Mecklenburg-Vorpommern)
GermanyAbgeschlossen» Google-Maps
Universitätsklinikum Würzburg; Frauenklinik
97080 Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps
UCSD Moores Cancer Center
92093 La Jolla
United StatesAbgeschlossen» Google-Maps
USC Norris Cancer Center
90033 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
USC Norris Cancer Center; USC Oncology Hematology Newport Beach
92663 Newport Beach
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente - Oakland
94611 Oakland
United StatesRekrutierend» Google-Maps
Emad Ibrahim, Md, Inc
92373 Redlands
United StatesZurückgezogen» Google-Maps
Kaiser Permanente - Roseville
95661 Roseville
United StatesRekrutierend» Google-Maps
Kaiser Permanente Sacramento Medical Center
95814 Sacramento
United StatesRekrutierend» Google-Maps
UC Davis; Comprehensive Cancer Center
95817 Sacramento
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente - San Francisco (2238 Geary)
94115 San Francisco
United StatesRekrutierend» Google-Maps
UCSF Comprehensive Cancer Ctr
94158 San Francisco
United StatesAktiv, nicht rekrutierend» Google-Maps
K. Permanente - San Jose
95119 San Jose
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente - San Leandro
94577 San Leandro
United StatesAktiv, nicht rekrutierend» Google-Maps
K. Permanente - Santa Clara
95051 Santa Clara
United StatesRekrutierend» Google-Maps
Kaiser Permanente - South San Francisco
94080 South San Francisco
United StatesRekrutierend» Google-Maps
Kaiser Permanente - Vallejo
94589 Vallejo
United StatesAktiv, nicht rekrutierend» Google-Maps
K. Permanente - Walnut Creek
94596 Walnut Creek
United StatesAktiv, nicht rekrutierend» Google-Maps
Memorial Regional Hospital
33021 Hollywood
United StatesRekrutierend» Google-Maps
Mount Sinai Comprehensive Cancer Center
33140 Miami Beach
United StatesRekrutierend» Google-Maps
UF Health Cancer Center at Orlando Health
32824 Orlando
United StatesRekrutierend» Google-Maps
Memorial Hospital West
33028 Pembroke Pines
United StatesRekrutierend» Google-Maps
Northwestern Center for Clinical Research; Cancer Center
60611 Chicago
United StatesZurückgezogen» Google-Maps
Rush University Medical Center; Div of Hematology
60612 Chicago
United StatesZurückgezogen» Google-Maps
University of Maryland
21201 Baltimore
United StatesAktiv, nicht rekrutierend» Google-Maps
Mercy Medical Center
21202 Baltimore
United StatesRekrutierend» Google-Maps
John Hopkins Sidney Kimmel Comprehensive Cancer Center
21287 Baltimore
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Mass General/North Shore Cancer
01923 Danvers
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center; MSK Monmouth
07748 Middletown
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center at Bergen
07645 Montvale
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center - Commack
11725 Commack
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center at Westchester
10604 Harrison
United StatesRekrutierend» Google-Maps
Westchester Medical Center Cancer Institute
10532 Hawthorne
United StatesZurückgezogen» Google-Maps
Memorial Sloan Kettering
10065 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center at Nassau
11553 Uniondale
United StatesRekrutierend» Google-Maps
Mid Ohio Onc Hematology Inc
43219 Columbus
United StatesZurückgezogen» Google-Maps
Oregon Health and Science University
97239 Portland
United StatesRekrutierend» Google-Maps
Vanderbilt Breast Center; Vanderbilt Health Pharmacy
37204 Nashville
United StatesZurückgezogen» Google-Maps
UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy
75390 Dallas
United StatesRekrutierend» Google-Maps
Houston Methodist Cancer Center
77030 Houston
United StatesZurückgezogen» Google-Maps
Oncology Consultants PA
77030 Houston
United StatesRekrutierend» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-Maps
Hospital Britanico
C1280AEB Ciudad Autonoma Bs As
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Centro Oncologico Riojano Integral (CORI)
F5300COE La Rioja
ArgentinaZurückgezogen» Google-Maps
Hosp Provincial D. Centenarios; Oncology Dept
S2002KDS Rosario
ArgentinaRekrutierend» Google-Maps
Calvary Mater Newcastle; Medical Oncology
2298 Waratah
AustraliaRekrutierend» Google-Maps
Westmead Hospital; Medical Oncology
2145 Wentworthville
AustraliaRekrutierend» Google-Maps
Mater Hospital; Cancer Services
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Cabrini Medical Centre; Oncology
3144 Malvern
AustraliaRekrutierend» Google-Maps
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
6149 Bull Creek
AustraliaRekrutierend» Google-Maps
Cliniques Universitaires St-Luc
1200 Bruxelles
BelgiumAktiv, nicht rekrutierend» Google-Maps
GHdC Site Notre Dame
6000 Charleroi
BelgiumAktiv, nicht rekrutierend» Google-Maps
UZ Leuven Gasthuisberg
3000 Leuven
BelgiumAktiv, nicht rekrutierend» Google-Maps
Santa Casa de Misericordia de Salvador
40050-410 Salvador
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
74605-070 Goiania
BrazilRekrutierend» Google-Maps
Hospital do Câncer de Londrina
86015-520 Londrina
BrazilRekrutierend» Google-Maps
Instituto Nacional de Cancer - INCa; Pesquisa Clinica
20231-050 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Hospital Sao Lucas - PUCRS
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital Nossa Senhora da Conceicao
91350-200 Porto Alegre
BrazilRekrutierend» Google-Maps
Faculdade de Medicina do ABC - FMABC
09060-650 Santo Andre
BrazilRekrutierend» Google-Maps
Hospital Perola Byington
01317-000 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital A. C. Camargo; Oncologia
01509-010 Sao Paulo
BrazilZurückgezogen» Google-Maps
Cross Cancer Institute ; Dept of Medical Oncology
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Bcca - Cancer Center Southern Interior
V1Y 5L3 Kelowna
CanadaRekrutierend» Google-Maps
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
V5Z 4E6 Vancouver
CanadaRekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaZurückgezogen» Google-Maps
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
H3T 1E2 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Servicio de Oncología Hospital Regional e Concepción
4070038 Concepcion
ChileZurückgezogen» Google-Maps
Sociedad de Investigaciones Medicas Ltda (SIM)
4810469 Temuco
ChileAktiv, nicht rekrutierend» Google-Maps
Hospital Base de Valdivia; Unidad de Oncología Médica
5111055 Valdivia
ChileZurückgezogen» Google-Maps
the First Hospital of Jilin University
130021 Changchun
ChinaZurückgezogen» Google-Maps
Sun Yat-sen Memorial Hospital
510000 Guangzhou
ChinaZurückgezogen» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaZurückgezogen» Google-Maps
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
210029 Nanjing City
ChinaZurückgezogen» Google-Maps
Fudan University Shanghai Cancer Center
200120 Shanghai City
ChinaZurückgezogen» Google-Maps
Liaoning cancer Hospital & Institute
110042 Shenyang
ChinaZurückgezogen» Google-Maps
Clinica CIMCA
10103 San Jose
Costa RicaAktiv, nicht rekrutierend» Google-Maps
ICIMED Instituto de Investigación en Ciencias Médicas
10108 San Jose
Costa RicaAbgeschlossen» Google-Maps
Masarykův onkologický ústav; Klinika komplexní onkologické péče
656 53 Brno
CzechiaAktiv, nicht rekrutierend» Google-Maps
Fakultni nemocnice Olomouc; Onkologicka klinika
779 00 Olomouc
CzechiaAbgeschlossen» Google-Maps
CHU Besançon - Hôpital Jean Minjoz
25030 Besançon Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Polyclinique Bordeaux Nord Aquitaine
33300 Bordeaux
FranceRekrutierend» Google-Maps
Centre Francois Baclesse; Oncologie
14076 Caen
FranceRekrutierend» Google-Maps
Centre Georges Francois Leclerc; Oncologie 3
21079 Dijon
FranceRekrutierend» Google-Maps
Centre Leon Berard; Oncologie Genetique
69373 Lyon
FranceZurückgezogen» Google-Maps
Centre Catherine De Sienne
44202 Nantes
FranceAktiv, nicht rekrutierend» Google-Maps
APHP - Hospital Saint Louis
75475 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Jean Godinot; Oncologie Medicale
51056 Reims CEDEX
FranceRekrutierend» Google-Maps
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
115 22 Athens
GreeceRekrutierend» Google-Maps
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
115 28 Athens
GreeceAktiv, nicht rekrutierend» Google-Maps
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
145 64 Athens
GreeceRekrutierend» Google-Maps
Euromedical General Clinic of Thessaloniki; Oncology Department
546 45 Thessaloniki
GreeceAktiv, nicht rekrutierend» Google-Maps
Orszagos Onkologial Intezet; Onkologiai Osztaly X
1122 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
3501 Miskolc
HungaryAbgeschlossen» Google-Maps
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
4400 Nyiregyhaza
HungaryAktiv, nicht rekrutierend» Google-Maps
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
6720 Szeged
HungaryAktiv, nicht rekrutierend» Google-Maps
Hetenyi Geza County Hospital; Onkologiai Kozpont
5004 Szolnok
HungaryAbgeschlossen» Google-Maps
Zala County Hospital ICU
8900 Zalaegerszeg
HungaryAktiv, nicht rekrutierend» Google-Maps
Indraprastha Apollo Hospitals
110076 New Delhi
IndiaRekrutierend» Google-Maps
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
110085 New Delhi
IndiaAktiv, nicht rekrutierend» Google-Maps
Max Super Speciality Hospital; Medical Oncology
110088 North WEST Delhi
IndiaNoch nicht rekrutierend» Google-Maps
HealthCare Global Cancer Centre; Medical Oncology
380060 Ahmedabad
IndiaAktiv, nicht rekrutierend» Google-Maps
Tata Memorial Hospital
400013 Mumbai
IndiaAktiv, nicht rekrutierend» Google-Maps
Grant Medical Foundation, Ruby Hall Clinic
411001 Pune
IndiaAktiv, nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
40138 Bologna
ItalyRekrutierend» Google-Maps
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
33081 Aviano
ItalyRekrutierend» Google-Maps
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
20141 Milano
ItalyZurückgezogen» Google-Maps
Ospedale Santa Maria Annunziata; Oncologia
50012 Bagno a Ripoli
ItalyRekrutierend» Google-Maps
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
35128 Padova
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center;Breast Oncology
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Fukushima Medical University Hospital
960-1295 Fukushima
JapanRekrutierend» Google-Maps
Hyogo College of Medicine Hospital
663-8501 Hyogo
JapanRekrutierend» Google-Maps
St. Marianna University School of Medicine Hospital
216-8511 Kanagawa
JapanRekrutierend» Google-Maps
Kanagawa Cancer Center
241-8515 Kanagawa
JapanAktiv, nicht rekrutierend» Google-Maps
Tokai University Hospital
259-1193 Kanagawa
JapanAktiv, nicht rekrutierend» Google-Maps
Kumamoto Shinto General Hospital
862-8655 Kumamoto
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
National Hospital Organization Osaka National Hospital
540-0006 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
Kinki University Hospital, Faculty of Medicine; Surgery
589-8511 Osaka
JapanRekrutierend» Google-Maps
Saitama Cancer Center, Breast Oncology
362-0806 Saitama
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
St. Luke's International Hospital
104-8560 Tokyo
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanRekrutierend» Google-Maps
Showa University Hospital; Breast Surgery
142-8666 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center
10408 Gyeonggi-do
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Inha University Hospital
22332 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Centro Médico Zambrano Hellion
66278 Monterrey
MexicoRekrutierend» Google-Maps
Merida | Investigacion Clinica
97125 Mérida
MexicoAbgeschlossen» Google-Maps
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
03100 Mexico City
MexicoRekrutierend» Google-Maps
Clinical Hospital; Oncology Department
7000 Bitola
North MacedoniaRekrutierend» Google-Maps
PHI University Clinic of Radiotherapy and Oncology; Breast malignancy
1000 Skopje
North MacedoniaAktiv, nicht rekrutierend» Google-Maps
PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
1000 Skopje
North MacedoniaRekrutierend» Google-Maps
Centro Medico Monte Carmelo
04001 Arequipa
PeruAktiv, nicht rekrutierend» Google-Maps
Hospital Daniel Alcides Carrion
07021 Callao
PeruAktiv, nicht rekrutierend» Google-Maps
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
15088 Lima
PeruAktiv, nicht rekrutierend» Google-Maps
Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica
15102 Lima
PeruRekrutierend» Google-Maps
Instituto Nacional de Enfermedades Neoplasicas
Lima 34 Lima
PeruAktiv, nicht rekrutierend» Google-Maps
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima 41 Lima
PeruZurückgezogen» Google-Maps
Clinica Ricardo Palma
Lima 27 San Isidro
PeruAktiv, nicht rekrutierend» Google-Maps
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
13014 Trujillo
PeruAktiv, nicht rekrutierend» Google-Maps
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
44-101 Gliwice
PolandAktiv, nicht rekrutierend» Google-Maps
Klinika Onkologii Klinicznej CO-I Kraków
Krakow
PolandZurückgezogen» Google-Maps
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
71-730 Szczecin
PolandZurückgezogen» Google-Maps
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
93-338 Łódź
PolandAktiv, nicht rekrutierend» Google-Maps
Moscow City Oncology Hospital #62
143423 Moscovskaya Oblast
Russian FederationAbgeschlossen» Google-Maps
Nizhny Novgorod Regional Clinical Oncology Center
603126 Nizhny Novgorod
Russian FederationZurückgezogen» Google-Maps
Arkhangelsk Regional Clinical Oncology Dispensary
163045 Arkhangelsk
Russian FederationRekrutierend» Google-Maps
Ivanovo Regional Oncology Dispensary
153040 Ivanovo
Russian FederationAktiv, nicht rekrutierend» Google-Maps
SBIH Kaluga Region Clinical Oncology Dispensary
248007 Kaluga
Russian FederationAbgeschlossen» Google-Maps
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
420029 Kazan
Russian FederationRekrutierend» Google-Maps
Blokhin Cancer Research Center; Combined Treatment
115478 Moscow
Russian FederationZurückgezogen» Google-Maps
Blokhin Cancer Research Center; Combined Treatment
115478 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
125284 Moscow
Russian FederationRekrutierend» Google-Maps
FSI Rostov research oncological institute of MoH and SD of RF; PAD
344037 Rostov-on-Don
Russian FederationRekrutierend» Google-Maps
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
390011 Ryazan
Russian FederationZurückgezogen» Google-Maps
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
197758 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
National University Hospital; National University Cancer Institute, Singapore (NCIS)
119228 Singapore
SingaporeRekrutierend» Google-Maps
National Cancer Centre; Medical Oncology
169610 Singapore
SingaporeRekrutierend» Google-Maps
Institute of Oncology Ljubljana
1000 Ljubljana
SloveniaAktiv, nicht rekrutierend» Google-Maps
Univerzitetni klinični center Maribor; Oddelek za onkologijo
2000 Maribor
SloveniaZurückgezogen» Google-Maps
The Oncology Center
4091 Durban
South AfricaAktiv, nicht rekrutierend» Google-Maps
Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital
2193 Johannesburg
South AfricaNoch nicht rekrutierend» Google-Maps
Medical Oncology Centre of Rosebank; Oncology
2196 Johannesburg
South AfricaAktiv, nicht rekrutierend» Google-Maps
Langenhoven Drive Oncology Centre
6045 Port Elizabeth
South AfricaZurückgezogen» Google-Maps
Steve Biko Academic Hospital; Oncology
0002 Pretoria
South AfricaAktiv, nicht rekrutierend» Google-Maps
Hospital Provincial de Castellon; Servicio de Oncologia
12002 Castellon de La Plana
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia; Servicio de Oncologia
14004 Córdoba
SpainRekrutierend» Google-Maps
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
28222 Majadahonda
SpainRekrutierend» Google-Maps
Hospital del Mar; Servicio de Oncologia
08003 Barcelona
SpainRekrutierend» Google-Maps
Hospital Univ Vall d'Hebron; Servicio de Oncologia
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic Barcelona; Servicio de oncologia
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital de Donostia; Servicio de Oncologia
20014 Guipuzcoa
SpainRekrutierend» Google-Maps
Hospital Ramon y Cajal; Servicio de Oncologia
28034 Madrid
SpainRekrutierend» Google-Maps
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
41013 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico Universitario; Oncologia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
50009 Zaragoza
SpainRekrutierend» Google-Maps
Changhua Christian Hospital; Dept of Surgery
500 Changhua
TaiwanZurückgezogen» Google-Maps
Chi Mei Medical Center Liou Ying Campus
736 Liuying Township
TaiwanAbgeschlossen» Google-Maps
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
11259 Taipei City
TaiwanRekrutierend» Google-Maps
VETERANS GENERAL HOSPITAL; Department of General Surgery
00112 Taipei
TaiwanRekrutierend» Google-Maps
National Taiwan Uni Hospital; General Surgery
100 Taipei
TaiwanRekrutierend» Google-Maps
Adana Baskent University Hospital; Medical Oncology
01120 Adana
TurkeyAktiv, nicht rekrutierend» Google-Maps
Ankara Onkoloji Eğitim ve Araştırma Hastanesi
06200 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Ankara City Hospital
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Studien-Informationen

Brief Summary:

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate hematologic and organ function within 14 days prior to treatment initiation

- Histologically documented TNBC or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

- Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)

- HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: patient has recurrent disease <=5 years of being on adjuvant endocrine therapy or if patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy.

- Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis

- Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status

- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and agreement to refrain from donating sperm

Exclusion Criteria:

- Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation

- Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval)

- History of or known presence of brain or spinal cord metastases

- Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)

- Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)

- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills

- Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents)

- Known human immunodeficiency virus (HIV) infection

- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of treatment (or anticipated need during study)

- Pregnant or breastfeeding, or intending to become pregnant during the study

- Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart failure, left ventricular ejection fraction [LVEF] <50%, active ventricular arrhythmia requiring medication, history of myocardial infarction within 6 months of treatment initiation, clinically significant electrocardiogram [ECG] abnormalities).

- Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease

- Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy

- Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy)

- History of Type I or Type II diabetes mellitus requiring insulin

- Grade >=2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia

- History of or active inflammatory bowel disease or active bowel inflammation

- Clinically significant lung disease (including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of opportunistic infections)

- Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of treatment

- Grade >=2 peripheral neuropathy

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months):
Progression-Free Survival (PFS) as determined by the Investigator using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)



Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months):
Proportion of participants with an objective response (ORR), defined as partial response or complete response on 2 consecutive occasions ≥4 weeks apart) as determined by the Investigator using RECIST v.1.1

2. Duration of Response (DOR) (Time Frame - Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months):
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause.

3. Clinical Benefit Rate (CBR) (Time Frame - From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, up to approximately 53 months):
Proportion of participants with a clinical benefit (CB), defined as an objective response (CR or PR), or stable disease for at least 24 weeks, as determined by the Investigator through the use of RECIST v1.1.

4. Overall Survival (OS) (Time Frame - From randomization up to death from any cause, up to approximately 53 months):
Time from randomization to death from any cause.

5. Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score (Time Frame - From Day 1 of Cycle 1 up to approximately 53 months):
GHS/HRQoL scores, assessed using selected questions from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

6. Time to Deterioration in Pain (Time Frame - From Day 1 of Cycle 1 up to approximately 53 months):
Time to deterioration in pain is defined as the first minimally important increase of >10 points from the baseline pain scale score of selected questions of the EORTC QLQ-C30 and will only be assessed in the cohort with HR+/HER2- breast cancer participants.

7. Incidence and Severity of Adverse Events (AEs) (Time Frame - From randomization up to approximately 53 months):
Percentage of participants with an adverse event (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0, including analysis of pre-specified AEs.

8. Changes in Vital Signs (Time Frame - From randomization up to approximately 53 months):
Change from baseline in selected vital signs.

9. Changes in Targeted Laboratory Results (Time Frame - From randomization up to approximately 53 months):
Change from baseline in selected laboratory test results.

10. Plasma Concentration of Ipatasertib and Its Metabolite (G-037720) (Time Frame - Day 1 and Day 15 of Cycle 1, and on Day 15 of Cycle 3)

Studien-Arme

  • Experimental: Ipatasertib + Paclitaxel
  • Experimental: Placebo + Paclitaxel

Geprüfte Regime

  • Ipatasertib:
    Ipatasertib, 400 milligrams (mg), administered orally once a day (QD) on Days 1−21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
  • Paclitaxel:
    Paclitaxel, 80 mg/square meter (m^2), administered intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
  • Placebo:
    Matching placebo, administered orally QD on Days 1−21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.

Quelle: ClinicalTrials.gov


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