Tirzepatide Weight Loss for MRD+ Early Breast Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT06517212
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Patients will receive tirzepatide once weekly for up to 2 years.

Study Details

This trial aims to asses if tirzepatide-induced weight loss 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.

Key Dates

Start date
Nov 26, 2024
Status verified
Feb 2026
Primary completion
Aug 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tirzepatide
    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.

Primary Outcome Measure

ctDNA efficacy [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical Center, Baylor Charles A Sammons Cancer CenterDallasTexas75246
Page E Blas, MA
[email protected]
214-820-5424

Find similar trials in Dallas, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center· Dallas, TX

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