Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

What Was Tested

This registered phase 2 trial tested Tirzepatide.

The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment.

Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).

It had 1 arm (groups): Tirzepatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Secondary objectives include assessing the safety and tolerability of tirzepatide for weight loss during this treatment.

The feasibility of using tirzepatide for weight loss intervention will be evaluated through discontinuation rates and completion of the treatment course.

Additionally, the trial will determine the 3-year invasive disease-free survival (IDFS) and 3-year distant relapse-free survival (DRFS) with the use of tirzepatide.

The study will also assess changes in Body Mass Index (BMI), body fat distribution (measured via Waist/Hip Ratio (WHR) and waist circumference), and obesity-related metabolic markers (including Blood Pressure, fasting insulin, fasting blood glucose, HgbA1c, cholesterol, LDL, HDL, triglycerides, IGF1, estrogen, and testosterone).

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Consent: Be willing and able to provide written informed consent for the trial. Age: Male or Female patients aged 18 years or older. Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumor blocks or unstained slides.

The full record lists 10 inclusion and 8 exclusion criteria; among the exclusions: active malignancy: have a concomitant active malignancy; performance status: have an eastern cooperative oncology group (ecog) performance status greater than 2; body mass index: have a bmi of less than 27 kg/m².

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-10-30 with completion listed for 2027-09-30.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Tirzepatide in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.