Breast CancerPhase 2TRIM-EBCNCT06517212
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
A Phase 2 study testing Tirzepatide in people with Breast Cancer and Breast Neoplasms, run by Baylor Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancers
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients ≥18 years of age
- Have a diagnosis of node-positive, hormone receptor-positive (ER+ > 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- If patients have synchronous bilateral ER+ breast cancers, tissue from both primary cancers should be submitted for next-generation sequencing (NGS) to inform ctDNA testing
- Patients with multifocal/multicentric cancers are eligible and the largest focus of cancer should be submitted for NGS evaluation. If tested, all tumor foci must meet have ER > 10%
- For patients who received neoadjuvant therapy and have discordant hormone receptor and/or HER2 results between the diagnostic biopsy (pre-treatment) and the surgical pathology (post-neoadjuvant treatment), the hormone receptor status and HER2 status of the post-treatment specimen will determine eligibility
- Overweight or obesity defined as body mass index (BMI) > 27 kg/m2
Show all 22Show fewer
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Have received at least 1 year of or having completed standard neo/adjuvant endocrine therapy. If adjuvant cyclin dependent kinase (CDK) 4/6 inhibitor therapy was prescribed, patients must have completed this therapy
- Positive ctDNA blood test as determined by the Haystack Oncology Haystack MRD tumor-informed ctDNA assay
- Patients must have formalin-fixed paraffin-embedded (FFPE) tissue from the primary tumor available for submission to Haystack Oncology to perform whole genome sequencing (WGS) to build customized mutation panel to monitor for plasma ctDNA
- No clinical evidence of metastatic breast cancer found on history, physical examination, complete blood count (CBC), comprehensive metabolic panel (CMP), and radiologic imaging following a finding of positive ctDNA
- Have adequate hematologic function, defined by:
- Absolute neutrophil count (ANC) >1500/µL
- Platelet count ≥100,000/ µL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
- Have adequate liver function, defined by:
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x the upper limit of normal (ULN)
- Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN
- Have adequate renal function, defined by:
- Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
- Patients must be accessible for treatment and follow-up
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry
Who cannot join
- Prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer
- Treatment with a GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies within the last 3 months
- History of severe hypersensitivity reaction to GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, or any combinations with GLP-1 receptor agonist therapies
- Insulin-dependent diabetes
- Has clinical evidence of diabetic retinopathy
- Clinical evidence or suspicion of metastatic breast cancer
Show all 26Show fewer
- Current or past invasive cancers, other than breast cancer, are not allowed except for:
- Adequately treated basal or squamous cell carcinoma of the skin
- Previously diagnosed invasive cancer treated with curative intent, with no evidence of disease recurrence for at least 5 years, and are considered low risk for future recurrence by the treating physician
- Patients with a second synchronous primary HER2-positive or triple negative breast cancer
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) or active or persistent hepatitis B or hepatitis C virus
- Has significant cardiovascular disease, such as:
- History of stroke, myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months
- Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.
- Has a known history of active tuberculosis
- Women who are pregnant or lactating. All patients of reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
- severe impaired lung functions as defined as spirometry and diffusing capacity of lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)
- history of gastroparesis, impaired gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drug (e.g., ulcerative diseases, uncontrolled nausea vomiting and/or diarrhea, malabsorption syndrome, or small bowel resection)
- Has a history of pancreatitis or current symptoms of untreated cholelithiasis
- Has a family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) or medullary thyroid cancer (MTC)
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or results in trial participation not being in the patient's best interest, in the opinion of the Treating Physician
- Has received an investigational agent within 4 weeks prior to study treatment; investigational monoclonal antibodies should have a 4-week (28 day) or 5 half-life washout period
- Any other investigational or anti-cancer treatments while participating in this study with the exception of standard adjuvant endocrine therapy, zoledronic acid, or denosumab
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246
Page E Blas, MA, 214-820-5424, page.blas@bswhealth.org
About this study
Official title: Adjuvant Tirzepatide Plus Standard of Care Endocrine Therapy in Patients With Obesity or Overweight Who Have Hormone Receptor-positive, HER2-negative, Node-positive Early Breast Cancer, With Molecular Residual Disease (MRD), as Determined by Circulating Tumor DNA (ctDNA)
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.
Read the detailed description
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 questions it aims to answer are:
- Does tirzepatide-induced weight loss lead to clearance of plasma ctDNA in the adjuvant setting in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence, and
- Does tirzepatide-induced weight loss prevent the development of overt metastatic disease and improve distant disease-free survival, in the two-year period following first detection of ctDNA in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence.
Researchers will assess clinical outcomes after the first 20 patients are enrolled and have taken tirzepatide for at least 6 months. If at least three of the first 20 evaluable patients demonstrate clearance of ctDNA on tirzepatide, or at least ten of the first 20 patients remain alive and free of distant metastatic disease during the two-year period following initial detection of ctDNA using the Kaplan-Meier method, an additional 28 ctDNA-positive patients will be enrolled.
Patients will screen for ctDNA every 3 months for up to 3 years or until ctDNA positivity, whichever comes first. Once positive, they will undergo radiologic imaging to confirm the absence of frank metastatic disease. If confirmed, patients will receive tirzepatide once weekly for up to 2 years, visit the clinic monthly for the first 6 months, and every other month thereafter.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancers
- Being tested
- Tirzepatide
- Keywords
- TRIM, TRIM EBC, TRIM-EBC, tirzepatide, MRD, ctDNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called ZepBound
Patients will receive tirzepatide once weekly for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| tirzepatide | Experimental | 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. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA efficacy
Clearance of the presence of plasma ctDNA within two years of documented ctDNA positivity at time of study entry.
Measured: 2 years
distant disease-free survival efficacy
Percentage of patients alive and free of distant metastatic disease at 2 years following detection of ctDNA at the time of study entry.
Measured: 2 years
Secondary outcomes (3)
ctDNA kinetic changes using Haystack MRD
Differences in ctDNA kinetics between patients who clear ctDNA versus patients who do not clear ctDNA while on tirzepatide using the Haystack MRD assay.
Measured: 2 years
Number of patients with Treatment-Related Adverse Events (Safety and Tolerability)
Number of patients with treatment related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 2 years
weight loss
Percentage of weight loss observed on tirzepatide associated with clearance or persistence of ctDNA in patients receiving standard adjuvant endocrine therapy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start26 Nov 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce A O'Shaughnessy, MD, Principal investigator, Baylor Scott & White The Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517212
- Sponsor's protocol ID
- 024-273
- Acronym
- TRIM-EBC
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Tirzepatide Plus Standard of Care Endocrine Therapy in Patients With Obesity or Overweight Who Have Hormone Receptor-positive, HER2-negative, Node-positive Early Breast Cancer, With Molecular Residual Disease (MRD), as Determined by Circulating Tumor DNA (ctDNA)
- ClinicalTrials.gov ID
- NCT06517212
- Acronym / sponsor ID
- TRIM-EBC / 024-273
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancers
- Keywords
- TRIM, TRIM EBC, TRIM-EBC, tirzepatide, MRD, ctDNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 questions it aims to answer are:
- Does tirzepatide-induced weight loss lead to clearance of plasma ctDNA in the adjuvant setting in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence, and
- Does tirzepatide-induced weight loss prevent the development of overt metastatic disease and improve distant disease-free survival, in the two-year period following first detection of ctDNA in patients with obesity or overweight who have HR+, HER2-, N+ early breast cancer who are at high risk of recurrence.
Researchers will assess clinical outcomes after the first 20 patients are enrolled and have taken tirzepatide for at least 6 months. If at least three of the first 20 evaluable patients demonstrate clearance of ctDNA on tirzepatide, or at least ten of the first 20 patients remain alive and free of distant metastatic disease during the two-year period following initial detection of ctDNA using the Kaplan-Meier method, an additional 28 ctDNA-positive patients will be enrolled.
Patients will screen for ctDNA every 3 months for up to 3 years or until ctDNA positivity, whichever comes first. Once positive, they will undergo radiologic imaging to confirm the absence of frank metastatic disease. If confirmed, patients will receive tirzepatide once weekly for up to 2 years, visit the clinic monthly for the first 6 months, and every other month thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tirzepatide | Experimental | Drug: TirzepatidePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female or male patients ≥18 years of age
- Have a diagnosis of node-positive, hormone receptor-positive (ER+ > 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Overweight or obesity defined as body mass index (BMI) > 27 kg/m2
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Have received at least 1 year of or having completed standard neo/adjuvant endocrine therapy. If adjuvant cyclin dependent kinase (CDK) 4/6 inhibitor therapy was prescribed, patients must have completed this therapy
Key exclusion criteria (26 listed)
- Prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer
- Treatment with a GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies within the last 3 months
- History of severe hypersensitivity reaction to GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, or any combinations with GLP-1 receptor agonist therapies
- Insulin-dependent diabetes
- Has clinical evidence of diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: ZepBoundPatients will receive tirzepatide once weekly for up to 2 years. | Drug | tirzepatide |
Primary outcome
ctDNA efficacy
Time frame: 2 years
Clearance of the presence of plasma ctDNA within two years of documented ctDNA positivity at time of study entry.
distant disease-free survival efficacy
Time frame: 2 years
Percentage of patients alive and free of distant metastatic disease at 2 years following detection of ctDNA at the time of study entry.
3 secondary outcomes
ctDNA kinetic changes using Haystack MRD
Time frame: 2 years
Number of patients with Treatment-Related Adverse Events (Safety and Tolerability)
Time frame: 2 years
weight loss
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joyce A O'Shaughnessy, MD principal investigator
Baylor Scott & White The Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Breast Cancer and Breast Neoplasms, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CORC Solid Tumor (214-818-8472, corcsolidtumor@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA efficacy (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.