A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

Completed · Early Phase 1

Conditions studied: Estrogen Receptor-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT03962647

Run by

Vanderbilt-Ingram Cancer Center

People needed

31

Starts

2019-07-08

Expected to finish

2024-07-14

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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