West Cancer Center

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BREAST; Neoadjuvant;WT1+;"INDUCT"

Title

GlaxoSmithKline 113172

Study Title

Site Link

NCT01220128

Malignancy

Breast Cancer, Early Breast Cancer

Stage

Stage 2

Disease Setting

Neoadjuvant

Line Of Therapy

N/A

Investigational Agent

GSK2302024A

Drug Class

WT1-A10 + AS15 Antigen-Specific Cancer Immunotherapeutic

Lee Schwartzberg, MD

Sponsor

GSK (GlaxoSmithKline)

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://clinicaltrials.gov/ct2/show/NCT01220128?term=gsk+113172&rank=1

Key Eligibility Criteria Details

WT1 antigen expression (positive, +),
Stage II or Stage III,
ECOG 0-1,
LVEF >50%,
Normal organ function by labs,
No inflammatory breast CA,
No diagnosis by incisional bx,
No symptomatic autoimmune dz,
No immunosuppressive agents or prednisone >10mg/day,
No heparin or warfarin.__

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

WT1-positive Any ER/PR/HER2 Status

Dosing Frequency

...

Control Agents

Group B- placebo; Group D- standard chemo; Group F (HER2+)- trastuzumab;

Study Protocol

Randomized