Actively Recruiting
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
Led by Baylor Research Institute · Updated on 2026-02-12
48
Participants Needed
1
Research Sites
318 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients 18 years of age or older
- Diagnosed with node-positive, hormone receptor-positive (ER+ > 10%), HER2-negative breast cancer within the past 15 years
- For synchronous bilateral or multifocal breast cancers, appropriate tissue samples submitted for genetic testing
- Overweight or obesity defined as body mass index (BMI) greater than 27 kg/m2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Received at least 1 year of or completed standard neo/adjuvant endocrine therapy; completed CDK 4/6 inhibitor therapy if prescribed
- Positive circulating tumor DNA (ctDNA) blood test confirmed by Haystack Oncology assay
- Availability of primary tumor tissue for whole genome sequencing
- No clinical evidence of metastatic breast cancer by examination, blood tests, and imaging after ctDNA positivity
- Adequate blood cell counts, liver, and kidney function as defined
- Accessible for treatment and follow-up
- Able to understand and provide written informed consent
You will not qualify if you...
- Prior bariatric surgery or endoscopic weight loss procedures after breast cancer diagnosis
- Treatment with GLP-1 or related receptor agonists within the last 3 months
- History of severe allergic reaction to GLP-1 or related therapies
- Insulin-dependent diabetes or diabetic retinopathy
- Clinical evidence or suspicion of metastatic breast cancer
- Current or past invasive cancers other than breast cancer, except certain treated skin cancers or cancers disease-free for 5 years
- Second primary HER2-positive or triple negative breast cancer
- Active infections requiring systemic therapy
- Known history of HIV or active hepatitis B or C
- Significant cardiovascular disease within last 6 months or severe heart failure
- Active tuberculosis
- Pregnant or breastfeeding women; reproductive potential patients must use effective contraception
- Severe or uncontrolled medical conditions affecting lung, liver, gastrointestinal function, or history of pancreatitis
- Family history of Multiple Endocrine Neoplasia Syndrome Type 2 or medullary thyroid cancer
- Conditions or treatments that could interfere with study participation or results
- Received investigational agents within 4 weeks prior to study treatment
- Use of investigational or anti-cancer treatments during study except standard approved therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
C
CORC Solid Tumor
CONTACT
P
Page E Blas, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here