Health TrialsbyHealthPanel

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

ConditionsObesity (Disorder)Breast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University

About this trial

This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biologically female

Age ≥ 18

Obesity as defined by current BMI ≥ 30 kg/m² or ≥ 27.5 kg/m² for individuals of Asian ancestry

Postmenopausal as defined by one or more of the following

Disqualifiers

Stage IV breast cancer

Concomitant use of CDK inhibitors

Concomitant use of antiHER2 therapy

The PI may be consulted regarding enrollment of females receiving other endocrine therapy medications

Trial design

Design model

Single group

Treatments tested in this trial

  • Tirzepatide

    Drug

    Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: DrugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants completing week 24 visit with all required assessments

Time frame
24 weeks

Secondary outcomes

1

Percent change in body weight from baseline to week 24

Time frame
Baseline, 24 weeks
2

Absolute change in visceral fat mass from baseline to week 24

As assessed by SECA scan

Time frame
Baseline, 24 weeks
3

Percent change in visceral fat mass from baseline to week 24

As assessed by SECA scan

Time frame
Baseline, 24 weeks
4

Absolute change in fasting glucose from baseline to week 24

Time frame
Baseline, 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov
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