West Cancer Center

BREAST: Neoadjuvant: Phase 1: HER2+: Immunotherapy combination: “GO29831- Neoadjuvant”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

Title

Genentech GO29831- Neoadjuvant

Study Title

Site Link

NCT02605915

Malignancy

Breast Cancer, Breast Neoadjuvant, HER2+

Stage

Stage 2

Disease Setting

Curative, Neoadjuvant

Line Of Therapy

Neoadjuvant

Investigational Agent

Atezolizumab

Drug Class

PD-L1 antibody

Greg Vidal, MD

Sponsor

Hoffmann-La Roche

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT02605915

Key Eligibility Criteria Details

Men or women
Primary tumor size >2cm
Stage at presentation cT2-cT4, cN0-cN3, cM0
HER2 positive disease (ISH positive and/or 3+ by IHC)
HLA-A2 positive (by central laboratory)
ECOG PS 0-2
Adequate lab tests
Baseline LVEF >50% by ECHO or MUGA
No prior systemic therapy for treatment or prevention of breast cancer
No history of DCIS unless >5 years prior to current diagnosis
No Grade 2 or higher peripheral neuropathy
No history of autoimmune disease, need for current immunosuppressants
No HBV/HCV/HIV

Objective

Primary- DLTs, Safety; Secondary- Anti-therapeutic antibody, VS results, number of cycles received, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 positive

Dosing Frequency

Control Agents

N/A

Study Protocol

Randomized