West Cancer Center

BREAST: Metastatic: Triple Negative; 1st line; "GO29227"

A randomized, phase II, multi-center, placebo-controlled study of ipatasertib (GDC-0068), an inhibitor of AKT, in combination with paclitaxel as front-line treatment for patients with metastatic triple-negative breast cancer

Title

Genentech GO29227

Study Title

Site Link

study/NCT02162719

Malignancy

Breast, Metastatic Triple Negative Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st

Investigational Agent

Ipatasertib

Drug Class

small molecule AKT inihibitor

Greg Vidal, MD, PhD

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

study/NCT02162719

Key Eligibility Criteria Details

Unresectable metastatic or locally advanced TNBC
Pre- or post-menopausal
ECOG PS 0-1
Tumor specimen (FFPE) must be available prior to randomization
Measurable disease per RECIST 1.1
No prior systemic anti-breast cancer therapy in metastatic or inoperable setting
No prior tx with AKT, PI3k, or mTOR inhibitors
No CNS disease

Objective

Primary- PFS: Secondary- OS, ORR, DoR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER/PR negative, HER2 negative

Dosing Frequency

Ipatasertib 400mg qday on days 1-21 of each 28 day cycle. Paclitaxel 80mg/m2 on Day 1, 8, and 15 of each 28 day cycle

Control Agents

Paclitaxel + placebo

Study Protocol

Randomized