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one high-risk feature. A recent joint analysis of the NSABP B-31 and NCCTG N9831 randomized phase III trials that led to these approvals showed that adjuvant trastuzumab added to chemotherapy increased 10-year overall survival from 75.2% to 84% and 10-year DFS from 62.2% to 73.7%, Salazar said. “So the question becomes, if you add the vaccine to trastuzumab to prevent recurrence, does it improve survival even more? And with this vaccine, it’s limited to those who are HLA-A2+, so that’s a small pool of breast cancer patients.” (About 40%–55% of the population has the HLA-A2 allele.) Mittendorf acknowledged that obstacles to bringing a HER2 vaccine forward exist. “The HER2 space is crowded,” she said. “Trastuzumab is no longer the only player. There is TDM-1 (Kadcyla). There is pertuzumab (Perjeta). These agents are being tested in the neoadjuvant and adjuvant setting. We will need to further investigate and see who really needs what. [HER2-targeted] therapies are expensive regimens” to combine, and they have side effects. The vaccine is nontoxic, is very inexpensive and might stimulate a memory response that would work against HER2 for life.” And that excites researchers. “The logic to test these vaccines is there and the potential is definitely there,” Slamon said. “It’s been known for a long time you that you could get an immune response to what you are immunizing against. But just because you can measure an immune response doesn’t mean it will translate into a clinical response or clinical benefit. You only know that by looking at clinical outcomes and that takes time.” Norwell owns the GP2 vaccine. Mittendorf is the principal investigator on vaccine trials that Galena Biopharma (NeuVax), Antigen Express (AE37), and Norwell sponsored. The M. D. Anderson Cancer Center receives financial support for each study patient enrolled. George E. Peoples Jr., M.D., F.A.C.S., a coauthor of the GP2 study, holds inventor rights to GP2.

Rising Double-Mastectomy Rates Attract Increasing Scrutiny