Tirzepatide Weight Loss for MRD+ Early Breast Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.

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

The registry classes the interventions as drug.

More on the Plan

The goal of this clinical trial is to learn if tirzepatide induced weight loss effects survival outcomes in high risk early breast cancer patients.

The main questions it aims to answer are: 1.

Does tirzepatide-induced weight loss lead to clearance of plasma ctDNA in the adjuvant setting in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence, and 2.

Patients will screen for ctDNA every 3 months for up to 3 years or until ctDNA positivity, whichever comes first.

Who Took Part

Enrollment: 48 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: Female or male patients ≥18 years of age. If patients have synchronous bilateral ER+ breast cancers, tissue from both primary cancers should be submitted for next-generation sequencing (NGS) to inform ctDNA testing. Overweight or obesity defined as body mass index (BMI) \> 27 kg/m2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Positive ctDNA blood test as determined by the Haystack Oncology Haystack MRD tumor-informed ctDNA assay.

The full record lists 21 inclusion and 26 exclusion criteria; among the exclusions: prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer; treatment with a glp-1/glucagon receptor agonist, gip/glp-1/glucagon receptor agonist, gip/glp receptor agonist, or any combinations with glp-1 receptor agonist therapies within the last 3 months; history of severe hypersensitivity reaction to glp-1/glucagon receptor agonist, gip/glp-1/glucagon receptor agonist, or any combinations with glp-1 receptor agonist therapies.

How the Study Was Run

It was run as a single-group and open-label study.

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 2024-11-26 with completion listed for 2029-08-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example ctDNA kinetic changes using Haystack MRD, Number of patients with Treatment-Related Adverse Events (Safety and Tolerability) and weight loss.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Tirzepatide in 48 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.