A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

February 17, 2015

Primary Completion Date

August 2, 2017

Study Completion Date

August 2, 2017

Conditions
Breast Cancer
Interventions
DRUG

Ipatasertib

Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.

DRUG

Paclitaxel

Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion QW for 3 cycles.

DRUG

Placebo

Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.

Trial Locations (42)

10003

Hospital San Pedro De Alcantara; Servicio de Oncologia, Cáceres

12002

Hospital Provincial de Castellon; Servicio de Oncologia, Castellon

15706

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

17007

Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia, Girona

25198

Hospital Universitari de Lleida Arnau de Vilanova, Lleida

28033

Centro Oncologico MD Anderson International Espana, Madrid

28040

Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid

Hospital Universitario Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28050

Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid

28208

Carolinas Healthcare System, Charlotte

28223

Hospital Quiron de Madrid; Servicio de Oncologia, Madrid

28922

Hospital Universitario Fundación Alcorcón, Alcorcón (Madrid)

28933

Hospital Rey Juan Carlos; Pharmacy, Móstoles

28943

Hospital Universitario de Fuenlabrada; Servicio de Oncologia, Madrid

29011

Hospital Regional Universitario Carlos Haya; hospital Materno Infantil, servicio de Farmacia, Málaga

29414

Roper Bon Secours St. Francis Cancer Center, Charleston

41013

Hospital Virgen del Rocio, Seville

41071

Hospital Universitario Virgen Macarena, Seville

43204

Hospital Universitari Sant Joan de Reus; Servicio de Oncologia, Reus

46010

Hospital Clinico Universitario; Oncologia, Valencia

68130

Nebraska Cancer Specialists; Oncology Hematology West, PC, Omaha

75063

Texas Oncology-Tyler, Irving

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

77024

Texas Oncology - Houston (Gessner), Houston

78503

South Texas Cancer Center - McAllen, McAllen

78705

Texas Oncology, Austin

78731

Texas Oncology Cancer Center, Austin

80228

Rocky Mountain Cancer Center - Lakewood (West), Lakewood

85704

Arizona Oncology Associates, PC-CASA, Tucson

93105

Sansum Medical Clinic, Inc., Santa Barbara

97213

Northwest Cancer Specialists - Portland (NE Hoyt St), Portland

98405

Northwest Medical Specialties, PLLC, Tacoma

02114

Massachusetts General Hospital, Boston

01923

Mass General/North Shore Cancer, Danvers

1099-023

IPO de Lisboa; Servico de Oncologia Medica, Lisbon

2674-514

Hospital Beatriz Angelo; Departamento de Oncologia, Loures

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

07014

Hospital Universitario Son Espases, Palma de Mallorca

07198

Hospital Son Llatzer; Servicio de Oncologia, Palma de Mallorca

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

08908

Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SOLTI Breast Cancer Research Group

OTHER

lead

Genentech, Inc.

INDUSTRY