Tirzepatide Weight Loss for MRD+ Early Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Tirzepatide
DrugPatients will receive tirzepatide once weekly for up to 2 years.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: tirzepatideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ctDNA efficacy
Clearance of the presence of plasma ctDNA within two years of documented ctDNA positivity at time of study entry.
Time frame
2 years2
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.
Time frame
2 yearsSecondary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
weight loss
Percentage of weight loss observed on tirzepatide associated with clearance or persistence of ctDNA in patients receiving standard adjuvant endocrine therapy.
Time frame
2 yearsOther outcomes
1
time to recurrence
Breast cancer distant disease-free survival, defined as the time from beginning tirzepatide therapy to the time of distant disease recurrence or death, over five years in ctDNA-positive patients who clear ctDNA versus patients who do not clear ctDNA while on tirzepatide.
Time frame
5 years2
exploratory molecular changes via Next Generation Sequencing (NGS), Flow Cytometry, and Reverse Phase Protein Array (RPPA)
Exploratory analysis of metabolic, hormonal and immune cell changes associated with weight loss on tirzepatide in early breast cancer patients. Exploratory analyses may include NGS, Flow Cytometry, and RPPA.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov