Oncology Clinical Trial Finder
Breast Cancer

Active, not recruiting • Phase I • Stage I, II, III • ER positive • Post-Menopausal • Brain Metastases absent • Interventional

The following is imported from ClinicalTrials.gov:

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

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

Study Design
Study type:


Estimated enrollment:

31 participant

Actual study start date:

July 8, 2019

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:


Arms and Intervention
  • 2-Week Ketogenic Diet

  • Letrozole

Inclusion criteria
  • 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)

Exclusion criteria
  • 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.

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Active, not recruiting

Estimated Enrollment:


Last Updated:


Principal Investigator

Brent Rexer, MD, PhD

Trial Sponsor

Vanderbilt-Ingram Cancer Center

Study Location (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States


© 2024 Outcomes4Me Inc. All rights reserved.