Tirzepatide for Breast Cancer Survivors with Obesity

Overseen By Henry Cheng

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: CDK inhibitors, AntiHER2 therapy, GLP-1 agonists

Disqualifiers: Stage IV breast cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tirzepatide, a medication for weight management, to determine its effectiveness for postmenopausal women with hormone receptor-positive breast cancer who are also dealing with obesity. The main goal is to assess whether these women can comfortably take the medication weekly for six months and if it aids in weight loss and health improvement. Participants must be biologically female, postmenopausal, and have a BMI of 30 or higher. The trial includes monthly check-ins and health assessments at the beginning and end. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

What is the safety track record for this treatment?

Research has shown that tirzepatide is generally well-tolerated by adults. In past studies, participants taking tirzepatide for weight loss lost a significant amount of weight, indicating its effectiveness in managing obesity. Importantly, these studies did not identify any major safety concerns.

One study focused on breast cancer survivors who took tirzepatide. It found that their cancer did not return more often than in those who did not take the drug, suggesting that tirzepatide might be safe for individuals with a history of breast cancer.

The FDA has already approved tirzepatide for treating type 2 diabetes, indicating it has passed strict safety checks for that condition. While this doesn't guarantee complete safety for every use, it does provide some reassurance about its overall safety.

In summary, current evidence suggests that tirzepatide is generally safe for use in humans, with no major safety issues reported in relevant studies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard care for obesity, which often involves lifestyle changes and medications targeting appetite or fat absorption, Tirzepatide is unique because it is a dual-action drug that mimics the hormones GLP-1 and GIP. These hormones are naturally involved in insulin release and appetite regulation, making Tirzepatide distinct in its ability to potentially improve both metabolic control and weight loss. Researchers are excited about Tirzepatide because it offers a promising new approach by tackling both obesity and metabolic issues simultaneously, which could be especially beneficial for breast cancer survivors managing weight-related health challenges.

What evidence suggests that tirzepatide might be an effective treatment for obesity in breast cancer survivors?

Studies have shown that tirzepatide helps reduce body weight and fat. One study found that people with obesity who took tirzepatide weekly lost significant weight over 72 weeks. Research also suggests that tirzepatide might slow tumor growth in some obesity-linked breast cancer cases. Additionally, cancer recurred less often in patients treated with tirzepatide. This evidence supports tirzepatide's potential to improve health outcomes for breast cancer survivors with obesity. ^{2 3 5 6 7}

Who Is on the Research Team?

Sarah Schmitz, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who have survived hormone receptor-positive breast cancer and are dealing with obesity. Participants should be willing to take tirzepatide once a week for 6 months, attend monthly check-ins, and undergo body assessments, blood tests, stool sample collection, and surveys at the start and end of the study.

Inclusion Criteria

Obesity as defined by current BMI ≥ 30 kg/m²

I am postmenopausal based on age, lack of periods, surgery, or treatment.

I am biologically female.

Exclusion Criteria

Enrollment in another investigational clinical trial

Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol

My doctor can talk to the study leader about my hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide once weekly for 6 months to assess its practicality and acceptability

24 weeks

Monthly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study is testing tirzepatide as a potential treatment to help improve weight and overall health in postmenopausal breast cancer survivors with obesity. The medication will be administered weekly over a period of six months with regular monitoring.

How Is the Trial Designed?

Group I: Drug Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. endocrine.org endocrine.org/news-and-advocacy/news-room/endo-annual-meeting/endo-2025-press-releases/kucinskas-press-release

Mouse study finds tirzepatide slowed obesity-associated ... The researchers found that the anti-obesity drug reduced body weight and body fat by approximately 20% in mice, similar to the amount of weight ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10849495/

Tirzepatide attenuates mammary tumor progression in diet- ... We conclude that tirzepatide represents a promising pharmacologic approach for mitigating the procancer effects of obesity.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06517212

Tirzepatide Weight Loss for MRD+ Early Breast Cancer ... 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 ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e24140

Impact of semaglutide and tirzepatide administration on ... Rates of local, locoregional, and distant breast cancer recurrence were 1.5%, 0%, 1.5% in the S/T treated patients and 1.3%, 4.7% and 3.3% in ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12186097/

The Impact and Safety of GLP‐1 Agents and Breast Cancer The study found that adults who received 5, 10, and 15 mg doses of tirzepatide experienced average weight reductions of 15% (95% CI: −15.9 to ...

7. academic.oup.com academic.oup.com/jes/article/9/Supplement_1/bvaf149.2433/8297317

SAT-291 Impact of the Incretin Mimetic Drug Tirzepatide on ... Tirzepatide also had beneficial effects on tumor outcomes, with a trend for reduction in tumor volume, compared to control mice. In addition, ...