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

PHASE3CompletedINTERVENTIONAL
Enrollment

579

Participants

Timeline

Start Date

January 6, 2018

Primary Completion Date

January 4, 2023

Study Completion Date

January 4, 2023

Conditions
Breast Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (176)

41

Oncosalud Sac; Oncología, Lima

100

National Taiwan Uni Hospital; General Surgery, Taipei

736

Chi Mei Medical Center Liou Ying Campus, Liuying Township

1000

PHI University Clinic of Radiotherapy and Oncology; Breast malignancy, Skopje

PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax, Skopje

Institute of Oncology Ljubljana, Ljubljana

1122

Orszagos Onkologial Intezet; Onkologiai Osztaly X, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2050

Chris O'Brien Lifehouse, Camperdown

2145

Westmead Hospital; Medical Oncology, Wentworthville

2196

Medical Oncology Centre of Rosebank; Oncology, Johannesburg

2298

Calvary Mater Newcastle; Medical Oncology, Waratah

3000

UZ Leuven Gasthuisberg, Leuven

3144

Cabrini Medical Centre; Oncology, Malvern

3501

Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly, Miskolc

4101

Mater Hospital; Cancer Services, South Brisbane

5004

Hetenyi Geza County Hospital; Onkologiai Kozpont, Szolnok

6000

GHdC Site Notre Dame, Charleroi

6149

Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit, Bull Creek

6720

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged

7000

Clinical Hospital; Oncology Department, Bitola

8900

Zala County Hospital ICU, Zalaegerszeg

10000

Dicle Uni Medical Faculty; Internal Medicine, Diyarbakır

10065

Memorial Sloan Kettering, New York

10103

Clinica CIMCA, San José

10108

ICIMED Instituto de Investigación en Ciencias Médicas, San José

10408

National Cancer Center, Goyang-si

10604

Memorial Sloan Kettering Cancer Center at Westchester, Harrison

10707

Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin

11259

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei

12002

Hospital Provincial de Castellon; Servicio de Oncologia, Castellon

13014

Instituto Regional de Enfermedades Neoplasicas - IREN Norte, Trujillo

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

15088

Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel, Lima

15102

Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica, Lima

15706

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela

18059

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt, Rostock

20014

Hospital de Donostia; Servicio de Oncologia, Guipuzcoa

20246

Universitätsklinikum Hamburg-Eppendorf; Frauenklinik, Hamburg

21079

Centre Georges Francois Leclerc; Oncologie 3, Dijon

21201

University of Maryland, Baltimore

21202

Mercy Medical Center, Baltimore

21287

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

22332

Inha University Hospital, Incheon

25030

CHU Besançon - Hôpital Jean Minjoz, Besançon

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28050

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid

28222

Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda

32429

Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe, Minden

32824

UF Health Cancer Center at Orlando Health, Orlando

33021

Memorial Regional Hospital, Hollywood

33028

Memorial Hospital West, Pembroke Pines

33081

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33300

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

34214

Medipol University Medical Faculty; Oncology Department, Istanbul

34298

ICM; Medecine B3, Montpellier

34384

Prof. Dr. Cemil Tascioglu City Hospital; Med Onc, Istanbul

35128

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padua

35360

Katip Celebi University Ataturk Training and Research Hospital; Oncology, Izmir

36022

National Cancer Institute MOH of Ukraine, Kiev

38138

West Clinic, Germantown

40138

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna

41013

Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Seville

44202

Centre Catherine De Sienne, Nantes

45659

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie, Recklinghausen

46010

Hospital Clinico Universitario; Oncologia, Valencia

49102

Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

50012

Ospedale Santa Maria Annunziata; Oncologia, Bagno a Ripoli

50679

Praxis Dr.med. Katja Ziegler-Löhr, Cologne

51056

Institut Jean Godinot; Oncologie Medicale, Reims

54100

Sakarya University Medical School; Medical Oncology, Sakarya

63225

Dres. Andreas Köhler und Roswitha Fuchs, Langen

66278

Centro Médico Zambrano Hellion, Monterrey

66424

Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe, Homburg/Saar

75246

Texas Oncology, P.A., Dallas

75390

UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy, Dallas

75475

APHP - Hospital Saint Louis, Paris

77030

Oncology Consultants PA, Houston

79031

Lviv State Oncological Regional Treatment and Diagnostic Center, Lviv

79110

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau

80131

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica, Napoli

90033

USC Norris Cancer Center, Los Angeles

92093

UCSD Moores Cancer Center, La Jolla

92663

USC Norris Cancer Center; USC Oncology Hematology Newport Beach, Newport Beach

94080

Kaiser Permanente - South San Francisco, South San Francisco

94115

Kaiser Permanente - San Francisco (2238 Geary), San Francisco

94158

UCSF Comprehensive Cancer Ctr, San Francisco

94577

Kaiser Permanente - San Leandro, San Leandro

94589

Kaiser Permanente - Vallejo, Vallejo

94596

K. Permanente - Walnut Creek, Walnut Creek

94611

Kaiser Permanente - Oakland, Oakland

95051

K. Permanente - Santa Clara, Santa Clara

95119

K. Permanente - San Jose, San Jose

95661

Kaiser Permanente - Roseville, Roseville

95817

UC Davis; Comprehensive Cancer Center, Sacramento

95825

Kaiser Permanente Sacramento Medical Center, Sacramento

97080

Universitätsklinikum Würzburg; Frauenklinik, Würzburg

110076

Indraprastha Apollo Hospitals, New Delhi

110085

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology, New Delhi

115478

Blokhin Cancer Research Center; Combined Treatment, Moskva

119228

National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore

125284

Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology, Moscow

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

163045

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk

168583

National Cancer Centre; Medical Oncology, Singapore

197758

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint Petersburg

248007

SBIH Kaluga Region Clinical Oncology Dispensary, Kaluga

344037

FSI Rostov research oncological institute of MoH and SD of RF; PAD, Rostov-on-Don

420029

Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan'

4800827

Sociedad de Investigaciones Medicas Ltda (SIM), Temuco

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

S2002KDS

Hosp Provincial D. Centenarios; Oncology Dept, Rosario

40050-410

Santa Casa de Misericordia de Salvador, Salvador

74605-070

Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia

86015-520

Hospital do Câncer de Londrina, Londrina

20560-120

Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

09060-650

Faculdade de Medicina do ABC - FMABC, Santo André

01317-000

Hospital Perola Byington, São Paulo

V5Z 4E6

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre, Vancouver

H3T 1E2

Jewish General Hospital, Montreal

656 53

Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e, Brno

779 00

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc

115 22

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine, Athens

145 64

Agioi Anargyroi; 3Rd Dept. of Medical Oncology, Athens

546 45

Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki

464-8681

Aichi Cancer Center Hospital, Aichi

277-8577

National Cancer Center Hospital East, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center;Breast Oncology, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

663-8501

Hyogo Medical University Hospital, Hyōgo

216-8511

St. Marianna University Hospital, Kanagawa

241-8515

Kanagawa Cancer Center, Kanagawa

259-1193

Tokai University Hospital, Kanagawa

862-8655

Kumamoto Shinto General Hospital, Kumamoto

951-8566

Niigata Cancer Center Hospital, Niigata

700-8558

Okayama University Hospital, Okayama

540-0006

National Hospital Organization Osaka National Hospital, Osaka

589-8511

Kinki University Hospital, Faculty of Medicine; Surgery, Osaka

362-0806

Saitama Cancer Center, Breast Oncology, Saitama

411-8777

Shizuoka Cancer Center, Shizuoka

104-0045

National Cancer Center Hospital, Tokyo

104-8560

St. Luke's International Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

142-8666

Showa University Hospital; Breast Surgery, Tokyo

06760

Centro Medico Dalinde, Mexico City

Yucatán

"Merida , Investigacion Clinica"

03100

CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO, Mexico City

04001

Centro Medico Monte Carmelo, Arequipa

07021

Hospital Daniel Alcides Carrion, Callao

Lima 34

Instituto Nacional de Enfermedades Neoplasicas, Lima

Lima 27

Clinica Ricardo Palma, San Isidro

93-338

Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej, ?ód?

44-101

Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter., Gliwice

02-781

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr, Warsaw

463-707

Seoul National University Bundang Hospital, Seongnam-si

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08035

Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

08036

Hospital Clinic Barcelona; Servicio de oncologia, Barcelona

00112

VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei

06490

Ankara Bilkent City Hospital, Ankara

03115

Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients, Kiev

CF14 2TL

Velindre Cancer Centre, Cardiff

CV2 2DX

University Hospital coventry; Oncology Department, Coventry

G12 0YN

The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit, Glasgow

SW3 6JJ

Royal Marsden Hospital - London, London

PL6 8BT

Derriford Hospital, Plymouth

ST4 6QG

Royal Stoke University Hospital, Stoke-on-Trent

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03337724 - 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 | Biotech Hunter | Biotech Hunter