ACCRU News & Releases – May 1, 2018

Approximately 15 percent of all breast cancer patients have triple negative breast cancer (TNBC), an aggressive form of cancer that has a poor prognosis. Patients with TNBC do not benefit from most approved available targeted therapies, such as trastuzumab, pertuzumab and tamoxifen. That’s why ACCRU investigators have developed a clinical trial to evaluate the effectiveness of immunotherapy as a treatment for these patients.

ACCRU trial RU011501I is testing a vaccine to stimulate the immune system of patients with TNBC who are disease-free following conventional therapy. The vaccine will encourage the production of T cells, which may prevent the re-emergence of TNBC. Targeted enrollment for the study is 280 patients.

“Immunotherapy holds tremendous potential for improving the treatment of breast cancer. We’re now working to make our eligibility criteria more inclusive to allow more patients to participate in this exciting trial,” says Kathryn Ruddy, M.D., M.P.H., associate professor of Oncology on Mayo Clinic’s Rochester campus and principal investigator for the trial.

The phase II, double-blind, randomized trial is evaluating vaccination with folate receptor alpha (FRα) peptide vaccine with GM-CSF as adjuvant therapy following oral cyclophosphamide, compared to GM-CSF/placebo, to prevent recurrence of TNBC.

“Targeting FRα is appealing because most TNBC expresses this protein, and a recent study showed that use of a FRα peptide vaccine induced immunity to the folate receptor antigen in 90 percent of patients with ovarian or breast cancer, regardless of HLA genotype,” says Dr. Ruddy.

Edith Perez, M.D., professor of Medicine, and Keith Knutson, Ph.D., professor of Immunology on Mayo Clinic’s campus in Jacksonville, Florida, are study co-chairs for the trial.

Trial objectives – Investigators developed the trial to address the following research objectives:

• Show that FRα peptide vaccine will prolong the disease-free survival in patients with triple negative breast cancer.

• Determine whether high level of antibody and cellular immune response toward the FRα at baseline is a prognostic factor for vaccine immune response and/or cancer relapse.

• Determine whether the level of FRα expression at baseline is a prognostic factor for vaccine immune response and/or cancer relapse.