Is NCT06517212 recruiting in Dallas, TX?

Yes, NCT06517212 is currently recruiting participants at its Dallas, TX location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Cancer Clinical Trial in Dallas, TX

About This Breast Cancer Study in Dallas

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.

Sponsor: Baylor Research Institute

Who Can Participate

Inclusion Criteria

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

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: a. 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

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT06517212) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Cancer Treatment Options in Dallas, TX

If you're searching for breast cancer treatment options in Dallas, TX, this clinical trial (NCT06517212) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Dallas, TX

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