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

NCT03962647 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Estrogen Receptor-positive Breast Cancer

Interventions

DIETARY_SUPPLEMENT

2-Week Ketogenic Diet

2-Week Ketogenic Diet in Combination with Letrozole

DRUG

Letrozole

2.5 mg taken once daily by mouth

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Brent Rexer, MD, PhD · Vanderbilt Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2024-03-07
Completion
2024-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962647 on ClinicalTrials.gov