Vanderbilt Clinical Trials

• All participants must provide written informed consent. - Patients must have histologically confirmed primary invasive mammary carcinoma - The tumor must be estrogen receptor positive - The tumor must be HER2 negative (negative IHC or FISH) - The primary tumor size must be at least 2 mm in size. - Patients must be post-menopausal defined by any of the following: - Subjects at least 55 years of age. - Subjects younger than 55 years of age and amenorrheic for at least 12 months or serum follicle-stimulating hormone (FSH) levels and estradiol levels in the post-menopausal range by local lab criteria - Subjects with history of bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months. - Patients must have clinical stage I, II, or III invasive mammary carcinoma planning to undergo surgical treatment with either segmental resection or total mastectomy. - Patients must have BMI >= 30. - A core biopsy from the time of diagnosis must be available. - Mammogram or ultrasound required prior to screening - Patients must have adequate organ function based on the following laboratory parameters: - Serum creatinine <= 1.5x ULN - SGOT, SGPT <= 4x ULN (unless known steatohepatitis) - Serum albumin >= 2.0 g/dL - Total serum bilirubin <= 1.5x ULN (or <= 3x ULN if known Gilbert's syndrome)

Patients with locally advanced disease who are candidates for other preoperative (chemo)therapy at the time of initial evaluation. This includes patients with inflammatory breast cancer. - Evidence of distant metastatic disease (stage IV). - Serious medical illness that in the judgment of the treating physician places the patient at high risk of operative mortality. - Serious medical illness that in the judgment of the treating physician would preclude the use of a ketogenic diet. - Severe uncontrolled malabsorption condition or disease (e.g. grade II/III diarrhea, severe malnutrition, short gut syndrome). - Diabetes mellitus requiring insulin therapy. - Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. - Participation in any other neoadjuvant therapeutic clinical trial. - Concurrent anti-cancer therapy other than endocrine therapy (e.g. chemotherapy, radiotherapy, immunotherapy, or any other biologic therapy). - Concurrent treatment with an investigational agent. - Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first day of dietary intervention.