Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer

After the patient has given their consent to participate in the trial, a series of tests will
be performed to determine if the patient is eligible. These tests may take place up to 21
days before the surgery to remove a tumor sample or cancer-containing fluid, which will be
used to create the vaccines. The tumor cells or fluid is then brought to a special, certified
laboratory where the vaccine is made. Specially trained laboratory technicians then use a
method known as adenoviral mediated gene transfer, which adds a new gene to the cancer cells.
This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune
system. The cells are then given radiation so that they will not grow. Participants will
start receiving vaccine on day 1, 8, 15, 29, and then every two weeks until the supply of
vaccine has run out. The amount of the vaccine depends upon the total amount of cells that
are obtained from the breast cancer tumor or fluid. Each time the patient is vaccinated, they
will be given injections that will be placed underneath the skin. A different place will be
used for each injection. If there are enough cells from the patient's tumor sample, the
patient will be given an injection of non-transduced irradiated cells (the gene was not
added) . These cells will help to measure how the patient's immune system is reacting to the
tumor cells. This is called Delayed-Type Hypersensitivity (DTH). With vaccine #1 and #5, the
patient will also receive a DTH injection. Two to three days after the vaccine and DTH
injection, skin biopsies will be taken of both sites. At week 10 in the study treatment, or
earlier if necessary, the patient will have a chest, abdomen, and pelvic CT scan to determine
if the vaccine therapy has had an effect on their disease. A brain MRI will be performed if
there were any abnormalities on the first brain MRI or if new symptoms have developed.
Patients may participate in this study until one of the following happens: All vaccine
created from the tumor has been given to the patient; the patient's disease worsens; the
patient experiences an unacceptable and/or harmful side effect; the patient is unable to
follow the study plan; or the patient's doctor feels it is no longer in the best interest of
the patient to continue.

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer, pre-operative stages
II-III per AJCC 6th edition, based on baseline evaluation by clinical examination
and/or breast imaging

- Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or
radiographic findings following their preoperative chemotherapy

- Cohort 2: Patients who have not received preoperative chemotherapy must have at least
4cm of disease in the largest diameter by clinical or radiographic findings

- Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant)
chemotherapy with either a standard regimen (containing an anthracycline and/or a
taxane) or on a clinical trial

- HER2 positive tumors must have received at least one prior trastuzumab-based therapy,
and may not receive concurrent trastuzumab therapy and vaccination

- Must initiate hormonal therapy (if indicated), including ovarian suppression, at least
4 weeks prior to initiation of vaccinations

- Must have completed definitive resection of primary tumor with adequated excision of
gross disease. Surgery should have occured more than 28 days but within 12 weeks prior
to enrollment

- May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and
aromatase inhibitors

- Must have had prior banked tumor of sufficient cellular yield for vaccination

- ECOG Performance Status 0 or 1

- 18 years of age or older

- Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy

- Adequate recovery from recent surgery and radiation therapy

Exclusion Criteria:

- Uncontrolled active infection or illness

- Other medical or psychiatric illness or social situation that would limit study
compliance

- Pregnancy or nursing mothers

- Evidence of HIV infection

- Previous participation in an adenovirus-based trial

- Concurrent invasive malignancies