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Tirzepatide for Weight Loss in Breast Cancer (FITWISE Trial)

Phase 2

Recruiting

Led By Coral Omene, MD., PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Organ Function: Demonstrate adequate organ function in screening labs

Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Must not have

Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2

Gastric Emptying Abnormality: Have a known clinically important gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically took drugs that directly affect gastrointestinal motility

Timeline

Screening 3 weeks

Treatment Varies

Follow Up metabolic markers will be evaluated through study completion for two years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if tirzepatide can help patients with a specific type of breast cancer lose at least 5% of their body weight. They will also check if tirzep

Who is the study for?

This trial is for individuals with early-stage hormone receptor-positive, HER2-negative breast cancer who are undergoing adjuvant treatment and aim to lose at least 5% body weight. Details on specific inclusion or exclusion criteria were not provided.

What is being tested?

The trial tests Tirzepatide's ability to help patients lose weight during breast cancer treatment. It also looks at the drug's safety, how many people can finish the treatment without stopping, and its impact on survival rates and body composition over three years.

What are the potential side effects?

While specific side effects of Tirzepatide in this context aren't detailed here, common ones may include digestive issues like nausea or diarrhea, potential low blood sugar levels, fatigue, and injection site reactions.

Eligibility Criteria

Inclusion Criteria

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

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My organ functions are within normal ranges according to my recent tests.

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I am able to care for myself and up to being unable to work but can still move around.

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I have tumor samples from a biopsy or surgery available.

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My breast cancer is hormone receptor-positive and HER2-negative.

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My heart's pumping ability is normal or above 50%.

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My breast cancer is in stage I, II, or III and has not been treated yet.

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I have completed all recommended treatments for breast cancer with the goal of curing it.

Exclusion Criteria

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

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My daily activity is limited due to my health condition.

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I have a severe stomach emptying issue or take medication that affects my stomach's movement.

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My breast cancer is either HER2-positive or triple-negative.

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I have another active cancer besides the one being treated.

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I have type 1 diabetes.

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My breast cancer is at stage IV and has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ adverse events will be monitored through study completion for two years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~adverse events will be monitored through study completion for two years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events will be monitored through study completion for two 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

Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction)

Secondary study objectives

Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, Weight and height will be combined to report BMI in kg/m^2.

Assessment of Obesity Measurements Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer, as measured by Waist/Hip Ratio (WHR), and waist circumference.

Assessment of Obesity-Related Metabolic Markers Using Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer Assessment of Blood Pressure Changes unit of Measure: Millimeters of mercury (mm Hg).

+12 more

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

Tirzepatide will be administered subcutaneously in the stomach, upper arm, or thigh, rotating injection sites with each dose. Administer once weekly at any time of day, with or without meals. Start with an initial dosage of 2.5 mg. After 4 weeks, increase to 5 mg weekly. Further increases may be made in 2.5 mg increments after at least 4 weeks on the current dose, aiming for a target of 15 mg (i.e., 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg). Consider treatment tolerability when selecting the maintenance dose. If not tolerated, consider the next lower maintenance dose. Recommended maintenance doses are 5 mg, 10 mg, or 15 mg, with 5 mg as the lowest evaluable dose. The 2.5 mg dose is not a maintenance dose. The maximum allowed dosage is 15 mg once weekly.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 13Eligibility criteria met