Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Public ClinicalTrials.gov record NCT06518837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).
Study identification
- NCT ID
- NCT06518837
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2024
- Primary completion
- Sep 29, 2027
- Completion
- Sep 29, 2027
- Last update posted
- Jan 20, 2026
2024 – 2027
United States locations
- U.S. sites
- 7
- U.S. states
- 1
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trinitas Comprehensive Cancer Center | Elizabeth | New Jersey | 07202 | Recruiting |
| RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton | Hamilton | New Jersey | 08690 | Not yet recruiting |
| RWJBarnabas Health - Cooperman Barnabas, Livingston | Livingston | New Jersey | 07039 | Recruiting |
| RWJBarnabas Health - Monmouth Medical Center | Long Branch | New Jersey | 07740 | Recruiting |
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | Recruiting |
| RWJBarnabas Health - Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | Recruiting |
| RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset | Somerville | New Jersey | 08876 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06518837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06518837 live on ClinicalTrials.gov.