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tirzepatide for Breast Cancer

Phase 2
Waitlist Available
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
1. Female or male patients ≥18 years of age
2. Have a diagnosis of node-positive, hormone receptor-positive (ER+ \> 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial aims to asses if tirzepatide-induced weight loss of ≥10% body weight 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.

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

Timeline

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
ctDNA kinetic changes using Haystack MRD
safety and efficacy
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
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide

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
~5560

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
205 Previous Clinical Trials
203,478 Total Patients Enrolled
4 Trials studying Breast Cancer
250 Patients Enrolled for Breast Cancer
Joyce A O'Shaughnessy, MDPrincipal InvestigatorBaylor Scott and White Research Institute
5 Previous Clinical Trials
3,204 Total Patients Enrolled
2 Trials studying Breast Cancer
3,020 Patients Enrolled for Breast Cancer
~32 spots leftby Aug 2029
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