CRC_ML25749

Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence

The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is node-positive (NP) (or node-negative [NN] if negative for both ER and PR) breast cancer patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care therapy. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed. E75 is a CD8-eliciting peptide vaccine that is restricted to HLA-A2+ or HLA-A3+ patients (approximately two-thirds of the US population).

Key Inclusion Criteria:

•Stage I-III
•Node positive
•Node negative if both ER/PR negative and have received chemotherapy
•HER2 1+ or 2+
•Clinically cancer-free
•ECOG 0 – 1
Phase II
NCT01570036
Cancer, All Other
Breast
Jason Lukas, M.D., Ph.D.
Cancer Insight, LLC
Katie Lyon
  • Providence Regional Cancer Partnership - Everett