A patient will be eligible for inclusion in this study only if ALL of the following
- Newly diagnosed histologically confirmed invasive breast cancer.
- Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2- (0 or 1+ by
IHC or FISH negative for amplification) breast cancer by AJCC 7th edition clinical
staging, with the goal being surgery to completely excise the tumor in the breast and
the lymph node. If the patient has invasive cancer in the contralateral breast, the
patient is not eligible for this study.
- At least 1 measurable lesion that is palpable and which can be measured by
bi-dimensional tape, ruler, or caliper technique. The minimum size of the largest
tumor diameter is at least 2.0 cm by imaging or physical examination.
- Candidate for neoadjuvant endocrine therapy.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 2.
- Adequate organ and marrow function no more than 14 days prior to registration as
- WBC 3,000/L
- absolute neutrophil count 1,500/L
- platelets 100,000/L
- total bilirubin institutional upper limit of normal
- AST/ALT 2.5 X institutional upper limit of normal
- creatinine institutional upper limit of normal OR creatinine clearance 60
mL/min/1.73 m2 for patients with creatinine above IULN
- Postmenopausal or premenopausal. NOTE: Postmenopausal women, verified by: (1)
bilateral surgical oophorectomy, or (2) no spontaneous menses 1 year or (3) no
menses for <1 year with FSH and estradiol levels in postmenopausal range, according
to institutional standards. Premenopausal women, verified by: (1) regular menses, or
(2) FSH and estradiol levels in premenopausal range, according to institutional
- Able to understand, and willing to sign a written informed consent document.
- A patient will be eligible for randomization only if both of the following criteria
- Confirmation that primary tumor expresses mammaglobin-A by IHC.
- Tumor Ki67 value is 10% after 14 days of endocrine therapy.
A patient will be ineligible for inclusion in this study if ANY of the following criteria
- Received any of the following for treatment of this cancer:
- Radiation therapy
- Hormonal therapy
- Investigational agent
- Receiving any other investigational agent(s) or has received an investigational agent
within the last 30 days.
- Known metastatic disease.
- Known allergy, or history of serious adverse reaction to vaccines such as
anaphylaxis, hives, or respiratory difficulty.
- Prior axillary lymph node sampling (sentinel lymph node biopsy or axillary lymph node
dissection). FNA of axillary lymph node is acceptable.
- Invasive cancer in the contralateral breast.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situation that would limit compliance with
- Prior or currently active autoimmune disease requiring management with
immunosuppression. This includes inflammatory bowel disease, ulcerative colitis,
Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis,
hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic
lupus erythematosus, Sjorgen's syndrome, sarcoidosis, or other rheumatologic disease
or any other medical condition or use of medication (e.g., corticosteroids) which
might make it difficult for the patient to complete the full course of treatments or
to generate an immune response to vaccines. Asthma or chronic obstructive pulmonary
disease that does not require daily systemic corticosteroids is acceptable. Any
patients receiving steroids should be discussed with the PI to determine if eligible.
- Pregnant or breastfeeding. A negative serum or pregnancy test is required no more
than 7 days before study entry, and patients must be willing to employ adequate
contraception. Women of childbearing potential must use two forms of contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation.
- Known HIV-positive status. These patients are ineligible because of the potential
inability to generate an immune response to vaccines.
- Subjects with a strong likelihood of non-adherence such as difficulties in adhering
to follow-up schedule due to geographic distance from the Siteman Cancer Center
should not knowingly be registered.
- Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue
for the eligible injection sites (left and right medial deltoid region) exceeds 40 mm
- Individuals in whom the ability to observe possible local reactions at the eligible
injection sites (deltoid region) is, in the opinion of the investigator, unacceptably
obscured due to a physical condition or permanent body art
- Therapeutic or traumatic metal implant in the skin or muscle of either deltoid
- Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or
hepatic or renal functional abnormality as determined by the investigator based on
medical history, physical examination, EKG, and/or laboratory screening test
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding
a single febrile seizure as a child
- Syncopal episode within 12 months of screening
- Current use of any electronic stimulation device, such as cardiac demand pacemakers,
automatic implantable cardiac defibrillator, nerve stimulators, or deep brain
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Female