A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer
The study is a single arm, open label, pilot study of safety and immune efficacy of peptide
vaccination with poly-ICLC in patients with stage IB-IIIA resected breast cancer.
Participants will be patients who have completed their last dose/treatment of any single
treatment or combination of adjuvant surgery, radiation, chemotherapy or trastuzumab therapy
between 45 days and 6 months (180 days) prior to enrollment.
Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. All participants
will receive 9 class I MHC-restricted synthetic peptides (restricted by HLA-A1, -A2, -A3, or
-A31) and a class II MHC-restricted tetanus helper peptide mixed with 1mg poly-ICLC and
administered in sterile water. The vaccine will be administered intramuscular (IM) (1 ml)
and intradermally (ID) (1 ml) at vaccination sites in the arm and leg. (Each vaccine given
IM and ID at one site; site to alternate between arm site opposite the breast cancer and an
anterior thigh site.) Participants will be screened for HLA type and must be HLA-A1, -A2,
-A3, or -A31 (80% of the Virginia population in prior studies1).
Annual follow-up for progression and survival for 3 years after study withdrawal/completion.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of dose limiting adverse events.
Patrick M Dillon, MD
University of Virginia
United States: Food and Drug Administration
|University of Virginia Health System||Charlottesville, Virginia 22903|