Breast Cancer Trial, Recruiting NCT07574671 Sponsor: The University of Texas Health Science Center at San Antonio Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT07574671
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give their consent to take part in the study
  • People who are 18 years of age or older at the time they give consent
  • People whose overall physical functioning is rated at a certain level by their doctor (a score of 2 or lower on a standard cancer patient health scale — confirm with trial site)
  • People who have gone through menopause at the time they join the study
  • People diagnosed with Stage I or II breast cancer (early-stage, not spread to distant parts of the body)
  • People who are planned to have breast surgery (either full or partial breast removal) as their first treatment, without needing any chemotherapy, hormone therapy, or other systemic treatment before surgery
  • People who have tissue available from their initial breast biopsy, taken as part of their standard care
  • People who, in the opinion of the study doctor, are able to follow a ketogenic (very low carbohydrate, high fat) diet and meet study requirements such as attending video appointments, using apps on a smartphone, measuring blood sugar and ketone levels at home, keeping a food and exercise diary, and preparing meals that fit the ketogenic diet

Who may not be able to join:

  • People whose doctors have determined they need treatment (such as chemotherapy or hormone therapy) before surgery
  • People whose breast surgery is planned to happen in less than 3 weeks from when they would join the study
  • People who are unable to follow a ketogenic diet
  • People who have been consistently following a ketogenic diet in the past 3 months
  • People who are already taking part in another structured diet program during the study period
  • People whose breast cancer is a type that does not start in the breast tissue lining, such as sarcoma or lymphoma
  • People with a Body Mass Index (a measure of body weight relative to height) below 18.5 (considered underweight)
  • People with other health conditions that, in the study doctor's opinion, would prevent them from safely taking part
  • People with Type 1 diabetes
  • People who use insulin or other diabetes medications taken by mouth to manage blood sugar
  • People who have experienced any of the following in the past 6 months: a heart attack, unstable chest pain (angina), a dangerous heart rhythm problem, severe sudden heart failure, a stroke, or a life-threatening spike in blood pressure
  • People with high blood pressure that remains uncontrolled even with blood pressure medication
  • People with end-stage kidney, liver, or heart disease
  • People with inherited genetic conditions that affect how the body processes fats (such as certain enzyme deficiencies — confirm specific conditions with trial site)
  • People with a condition called G6PD deficiency, which affects red blood cells
  • People with conditions that affect how the body absorbs food, such as inflammatory bowel disease, a history of gastric sleeve surgery, or prior bowel removal surgery
  • People with a history of recurring kidney stones or a known predisposition to developing them
  • People with very high triglyceride (blood fat) levels of 500 or above
  • People with known mental health or substance use conditions that would interfere with taking part in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Saba Shaikh, MD, The University of Texas Health Science Center at San Antonio

Phone: 210-450-5098

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
The University of Texas Health Science Center at San Antonio
Registry
ClinicalTrials.gov
Start date
2 April 2026
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in tumor immune microenvironment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov