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NCT06518837 · ClinicalTrials.gov registry record · Phase 2
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
A Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT06518837: Recruiting Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Rutgers, The State University of New Jersey.
NCT06518837 is a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 40 participants, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06518837, a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study Summary
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).
Primary Outcome
To determine the effectiveness of tirzepatide in facilitating a 5% or more weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer.
Conditions Studied
Interventions
- DRUG Tirzepatide
Study Locations (7)
New Jersey
- Trinitas Comprehensive Cancer Center - Elizabeth
- RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton - Hamilton
- RWJBarnabas Health - Cooperman Barnabas, Livingston - Livingston
- RWJBarnabas Health - Monmouth Medical Center - Long Branch
- Rutgers Cancer Institute - New Brunswick
- RWJBarnabas Health - Newark Beth Israel Medical Center - Newark
- RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset - Somerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-10-30 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What NCT06518837 shows while recruiting
NCT06518837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Tirzepatide is the first listed.
NCT06518837 lists 7 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT06518837 about?
NCT06518837 is a clinical study titled "Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer". 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 tirzepatid...
What is the current status of trial NCT06518837?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-10-30. Estimated completion is 2027-09-30.
What conditions does trial NCT06518837 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer.
What interventions are being tested in trial NCT06518837?
The interventions under investigation include: Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT06518837?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06518837 being conducted?
This trial has 7 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06518837's enrollment target sits among peer trials
40 32nd of 49 higher than 18 of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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