A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

August 19, 2014

Primary Completion Date

June 7, 2016

Study Completion Date

August 31, 2019

Conditions
Breast Neoplasms
Interventions
DRUG

Ipatasertib

Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.

DRUG

Paclitaxel

Participants received paclitaxel 80 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.

DRUG

Placebo

Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.

Trial Locations (44)

333

Chang Gung Medical Foundation - Linkou; Dept of Surgery, Taoyuan District

710

Chi Mei Medical Center, Yong kang; Endocrinology, Tainan City

2610

Sint Augustinus Wilrijk, Wilrijk

10002

National Taiwan University Hospital, Taipei

10408

National Cancer Center, Goyang-si

13605

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre Francois Baclesse, Caen

20133

Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica, Milan

22015

Clinique Armoricaine de Radiol, Saint-Brieuc

23007

Complejo Hospitalario de Jaen, Jaén

26056

West Virginia University Hospitals Inc, Morgantown

28033

MD Anderson Cancer Center, Madrid

28050

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

28208

Carolinas Healthcare System, Charlotte

33021

Memorial Healthcare System, Hollywood

33076

Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, Bordeaux

33308

Holycross Medical Group, Fort Lauderdale

34298

Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque, Montpellier

34952

Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie

35128

Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera, Padua

38119

The WEST CLINIC, P.C., Memphis

40402

China Medical University Hospital, North Dist.

41013

Hospital Virgen del Rocio, Seville

60612

Rush University Medical Center, Chicago

75475

Hopital Saint Louis; Oncologie Medicale, Paris

77030

MD Anderson Cancer Center, Houston

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

84403

Northern Utah Associates, Ogden

89014

Comprehensive Cancer Centers of Nevada, Henderson

90048

Cedars Sinai Medical Center, Los Angeles

90404

UCLA Medical Center, Santa Monica

92835

St Jude Heritage Medical Group, Fullerton

98499

Northwest Medical Specialties, Lakewood

119228

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

169610

National Cancer Centre, Singapore

90095-1772

Cancer Care Assoc Med Group, Los Angeles

67214-3728

Cancer Center of Kansas, Wichita

02114

Massachusetts General Hospital Cancer Center, Boston

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08908

Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY