Overview

Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our target study population is high-risk HER2-positive breast cancer patients. High-risk HER2-positive breast cancer patients are defined as: Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR. Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo surgery as a first intervention and are found to have ≥ 4 positive lymph nodes. Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a first intervention and are found to have 1-3 positive lymph nodes. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed.

Phase:

Phase 2

Details

Lead Sponsor:

Cancer Insight, LLC

Collaborators:

Galena Biopharma, Inc.
Genentech, Inc.
Sellas Life Sciences Group

Treatments:

Sargramostim
Trastuzumab
Vaccines