WASHINGTON UNIVERSITY: A P1b randomized clinical trial to evaluate safety and immune response to a mammaglobin-A DNA vaccine in breast cancer patients undergoing neoadjuvant endocrine therapy

Year of Grant: 2014

Location: United States


Cancer vaccines have generated considerable enthusiasm to date, both as an innovative treatment modality for established disease, but also because of their tremendous potential for cancer prevention.  Current surrogates for vaccine efficacy are imperfect, which is a major weakness in the cancer vaccine field. Many cancer vaccines have successfully induced immune responses in the peripheral blood but have failed to induce antitumor responses.


This phase 1b clinical trial seeks to addresses this limitation, as the immune response will be analyzed in both the primary tumor and the peripheral blood. 25 breast cancer patients undergoing neoadjuvant endocrine therapy will be randomized to neoadjuvant endocrine therapy alone (Arm 1), or neoadjuvant endocrine therapy plus mammaglobin-A DNA vaccination (Arm 2). The hypothesis is that the mammaglobin-A DNA vaccine will be safe and capable of generating mammaglobin-A-specific CD8 T cell responses.


Mammaglobin-A was first identified by the researchers as a near-universal breast cancer associated antigen with unique properties that make it an exceptional target for breast cancer therapy and prevention. The group developed a novel mammaglobin-A DNA vaccine for breast cancer, whose safety and strong preliminary evidence of biologic efficacy have already been demonstrated in a Phase 1 clinical trial.