A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

February 13, 2018

Primary Completion Date

March 16, 2022

Study Completion Date

March 16, 2022

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 all arms except for arms F1/F2 where it will be administered at a dose of 300 milligrams (mg) orally daily for the first two cycles and 400 mg for the remaining three cycles.

DRUG

Paclitaxel

Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion on Days 1, 8, and 15 of each 28 day cycle for all arms, with the exceptions of Arms F1, F2, G1 and G2, where it will be also administered on Day 22 as well, of each 28 day cycle.

DRUG

Atezolizumab

Atezolizumab will be administered by IV infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28 day cycle for all arms, although in Arms C1/C2, it will be administered on Day 15 of Cycle 1 followed by Days 1 and 15 in subsequent cycles.

DRUG

Nab-Paclitaxel

Nab-paclitaxel will be administered by IV infusion at a dose of 100 mg/m\^2 on Days 1, 8, and 15 of each 28 day cycle.

DRUG

AC

AC (Doxorubicin and Cyclophosphamide) will be administered by IV infusion at 60 mg/m\^2 and 600 mg/m\^2 respectively on Days 1 and 15 of Cycles 1 and 2 for Arms F1, F2, G1 and G2.

Trial Locations (18)

2010

St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept, Darlinghurst

3051

Peter MacCallum Cancer Center, North Melbourne

3084

Austin Hospital, Heidelberg

8041

Hospital de la Santa Creu i Sant Pau, Barcelona

21000

Centre Georges Francois Leclerc, Dijon

28040

Hospital Clinico San Carlos; Servicio de Oncologia, Madrid

Hospital Universitario Fundacion Jimenez Diaz., Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

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

33076

Institut Bergonie, Bordeaux

41013

Hospital Universitario Virgen del Rocío, Seville

49055

Institut de Cancerologie de l Ouest, Angers

75005

Institut Curie, Paris

90813

Pacific Shores Medical Group, Long Beach

94805

Gustave Roussy, Villejuif

280146

Hospital Universitario La Paz, Madrid

E1 2AT

Barts Cancer Institute, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03800836 - A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer | Biotech Hunter | Biotech Hunter