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Tirzepatide for Breast Cancer and Obesity (TRIM-EBC Trial)

Phase 2

Recruiting

Led By Joyce A O'Shaughnessy, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No clinical evidence of metastatic breast cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

Clinical evidence of diabetic retinopathy

Family history of MEN 2 or MTC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a weight loss of at least 10% with tirzepatide can cause changes in metabolism and hormones in breast cancer patients. The goal is to potentially stop the

Who is the study for?

This trial is for individuals with obesity or overweight who have high-risk early breast cancer that's hormone receptor-positive, HER2-negative, and node-positive. They must also have detectable circulating tumor DNA (ctDNA) indicating the presence of micrometastatic disease.

What is being tested?

The trial is testing whether Tirzepatide can help patients lose at least 10% body weight and if this weight loss leads to metabolic and hormonal changes that may stop the growth of tiny cancer spreadings and clear ctDNA, potentially preventing metastatic disease.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with weight loss medications like Tirzepatide may include gastrointestinal issues such as nausea, diarrhea, reduced appetite; potential low blood sugar; and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has not spread to other parts of my body.

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I am fully active or have some restrictions but can still take care of myself.

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My blood test for cancer DNA, using the Haystack method, is positive.

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I am overweight with a BMI over 27 and have gained more than 10% of my lowest weight since my breast cancer diagnosis.

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I have completed at least 1 year of hormone therapy for cancer.

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I can provide a tissue sample from my primary tumor for genetic testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with diabetic retinopathy.

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My family has a history of MEN 2 or medullary thyroid cancer.

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I am suspected to have or have been diagnosed with breast cancer that has spread.

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I use insulin for my diabetes.

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I have had weight loss surgery after being diagnosed with breast cancer.

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I have a serious heart condition.

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I have had pancreatitis or gallstones that were not treated.

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I am currently on medication for an infection.

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I have a history of HIV or hepatitis B or C.

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I have an active tuberculosis infection.

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I have a second breast cancer that is either HER2-positive or triple negative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ctDNA efficacy

distant disease-free survival efficacy

Secondary study objectives

Number of patients with Treatment-Related Adverse Events (Safety and Tolerability)

ctDNA kinetic changes using Haystack MRD

weight loss

Other study objectives

exploratory molecular changes via Next Generation Sequencing (NGS), Flow Cytometry, and Reverse Phase Protein Array (RPPA)

time to recurrence

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: tirzepatideExperimental Treatment1 Intervention

Patients will be treated with tirzepatide 15mg subcutaneously (SC) weekly (starting with 2.5mg SC weekly and increasing by 2.5mg monthly over 6 months) and will be monitored closely for tolerability, safety, and weight loss. Patients may be treated with tirzepatide for up to 2 years on trial if they remain without evidence of metastatic disease recurrence and provided there's demonstrated safety of tirzepatide with associated weight loss.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 17Eligibility criteria met