COMPLETED • Phase I • Stage I, II, III • ER positive • Post-Menopausal • Brain Metastases absent • Interventional
The following is imported from ClinicalTrials.gov:
This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.
Primary Objective: • To evaluate the feasibility and tolerability of a 2 week ketogenic diet in combination with endocrine therapy prior to surgery for early stage ER+ breast cancer. Secondary Objectives * To determine whether endocrine therapy in combination with a dietary intervention to reduce insulin pathway signaling results in enhanced inhibition of cancer cell proliferation (measured byKi67) * To determine the effectiveness of 2 weeks of a ketogenic diet to reduce measures of insulin/PI3Kpathway activation in breast tumors * To measure changes in weight and body composition after 2 weeks of a ketogenic diet * To measure changes in insulin resistance after 2 weeks of a ketogenic diet * To measure the effectiveness of a ketogenic diet in combination with endocrine therapy to induce and maintain a ketogenic state. Outline: Participants will have baseline metabolic parameters measured and will begin a 2-week diet consisting of meal replacement shakes to induce a ketogenic state. Patients will also receive letrozole 2.5 mg daily. At the end of 2 weeks, metabolic parameters will again be measured and patients will proceed with surgical treatment of their breast cancer. A tumor biopsy from the surgical specimen will be obtained to measure cell proliferation compared with the pre-treatment diagnostic biopsy.
Breast Cancer
INTERVENTIONAL
31 participant
Invalid date
18 - 999
female
2-Week Ketogenic Diet
Letrozole
* 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.
COMPLETED
31
10/29/2024
Brent Rexer, MD, PhD
Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
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