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Breast Diseases

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Vaccines

* Will be treated with standard of care adjuvant endocrine therapy as determined by their treating physician
* Optional biopsy approximately 14 days following initiation of neoadjuvant therapy

* Will be treated with standard of care adjuvant endocrine therapy
* Optional biopsy approximately 14 days following initiation of neoadjuvant therapy
* Treated with 4 mg of mammaglobin-A DNA vaccine at 3 time points (Days 28, 56, and 84)
* All study injections will be administered using a TriGrid electroporation device

* Will be treated with standard of care neoadjuvant chemotherapy as determined by their treating physician
* If archival tissue not sufficient, a research biopsy to obtain primary tissue must be done prior to day 28
* Subjects who begin neoadjuvant endocrine therapy but are determined to not be responding at the Day 14 biopsy may begin chemotherapy treatment, at the discretion of the treating physician. These subjects may be enrolled in cohort 3

* Will be treated with standard of care neoadjuvant chemotherapy as determined by their treating physician
* If archival tissue not sufficient, a research biopsy to obtain primary tissue must be done prior to day 28
* Treated with 4 mg of mammaglobin-A DNA vaccine at 3 time points (Days 28, 56, and 84)
* All study injections will be administered using a TriGrid electroporation device
* Subjects who begin neoadjuvant endocrine therapy but are determined to not be responding at the Day 14 biopsy may begin chemotherapy treatment, at the discretion of the treating physician. These subjects may be enrolled in either cohort 4

Mammaglobin-A DNA Vaccine

Optional biopsy

William Gillanders, M.D.

The purpose of this research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way to generate an immune response to breast cancer cells. There is evidence that an immune response may be a way to fight cancer. In addition to evaluating the safety of the mammaglobin-A injection, this study is also looking at the immune response that the participant's body has after each injection.

Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy

A Phase 1B Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in ER+, HER2- Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy or Chemotherapy

-ORR=complete response (CR) + partial response (PR)

* Complete response: disappearance of all lesions and normalization of tumor marker level
* Partial response: at least a 30% decrease in the sum of the diameters of target lesions and no new lesions

Assessment of plasmid DNA safety will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial. The following parameters will be assessed following vaccination:

1. Local signs and symptoms
2. Systemic signs and symptoms
3. Laboratory evaluations, including blood counts and serum chemistries
4. Adverse and serious adverse events

Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0

ELISPOT analyses and intracellular cytokine expression analyses using multi-parameter flow cytometry, and peptide MHC tetramer analyses will be performed. Peripheral blood will be obtained at two independent time points before vaccination (Pre-study, and Day 28 +/- 7 days), and at four independent time points following vaccination (Day 56 +/- 7 days, Day 84 +/- 7 days, Day 112 +/- 7 days, and Day 365 +/- 28 days).

◦Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one more new lesions PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Spots Global Cancer Trial Database for optional biopsy