Recruiting PHASE4 Obesity (Disorder)

New treatment option for Obesity (Disorder)

Official title Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

ClinicalTrials.gov ID: NCT07257484

What this study is testing

What is Tirzepatide?

Tirzepatide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obesity (disorder).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • Biologically female
  • Age ≥ 18
  • Obesity as defined by current BMI ≥ 30 kg/m²
  • Postmenopausal as defined by one or more of the following
  • Age ≥60 years

You likely can't join if

  • 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
  • Other active malignancy requiring treatment
  • Enrollment in another investigational clinical trial
See the full eligibility criteria
Who can join
  • Biologically female
  • Age ≥ 18
  • Obesity as defined by current BMI ≥ 30 kg/m²
  • Postmenopausal as defined by one or more of the following
  • Age ≥60 years
  • Age \<60 years with amenorrhea for ≥ 1 year
  • Documented bilateral surgical oophorectomy
  • Chemical menopause with the addition of LHRH agonists at least 12 weeks prior to enrolment, and plan to remain on LHRH agonists throughout the trial
  • HR+ (ER and/or PR) stage 0-III breast cancer
  • Completed curative treatment (surgery, chemotherapy, radiotherapy) at least 12 weeks prior to enrolment
  • Insurance approval for tirzepatide or willing to pay out of pocket
  • Willing to provide informed consent and comply with study procedures
What rules you out
  • 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
  • Other active malignancy requiring treatment
  • Enrollment in another investigational clinical trial
  • Contraindication to tirzepatide
  • Treatment with a GLP-1 receptor agonist within the last 3 months
  • Diabetes requiring insulin
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • New York, New York, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.