Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.
Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study.
Capable of providing informed consent and willing to comply with study procedures
Biopsy-proven ER+ DCIS
The signed pathology report from the attending pathologist will be used to determine eligibility
Invasive breast cancer > 1mm on pathologic evaluation
Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)
Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
Recurrent ipsilateral DCIS
Finn, Olivera, PhD
Lead sponsor
University of Pittsburgh
Sponsor institution
A Glimmer of Hope Foundation
Collaborator
Breast Cancer Research Foundation
Collaborator