Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

Part of paid clinical trials in Elizabeth, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06518837
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HER2-Negative Breast Cancer
  • Hormone Receptor-Positive Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    The intervention aims to assess the feasibility, safety, and efficacy of tirzepatide for weight loss in patients with early-stage hormone receptor-positive, HER2-negative breast cancer, potentially improving treatment outcomes and overall health.

Study Details

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).

Key Dates

Start date
Oct 30, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Tirzepatide will be administered subcutaneously in the stomach, upper arm, or thigh, rotating injection sites with each dose. Administer once weekly at any time of day, with or without meals. Start with an initial dosage of 2.5 mg. After 4 weeks, increase to 5 mg weekly. Further increases may be made in 2.5 mg increments after at least 4 weeks on the current dose, aiming for a target of 15 mg (i.e., 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg). Consider treatment tolerability when selecting the maintenance dose. If not tolerated, consider the next lower maintenance dose. Recommended maintenance doses are 5 mg, 10 mg, or 15 mg, with 5 mg as the lowest evaluable dose. The 2.5 mg dose is not a maintenance dose. The maximum allowed dosage is 15 mg once weekly.

Primary Outcome Measure

Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction) [ Time Frame: Through study completion, total of two years. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Trinitas Comprehensive Cancer CenterElizabethNew Jersey07202
Coral Omene, MD.,PhD
[email protected]
732-235-3374
RWJ Barnabas Health - Robert Wood Johnson University Hospital, HamiltonHamiltonNew Jersey08690
Coral Omene, MD.,PhD
[email protected]
732-235-3374
RWJBarnabas Health - Cooperman Barnabas, LivingstonLivingstonNew Jersey07039
Coral Omene, MD.,PhD
[email protected]
732-235-3374
RWJBarnabas Health - Monmouth Medical CenterLong BranchNew Jersey07740
Coral Omene, MD., PhD
[email protected]
732-235-3374
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Coral Omene,, MD.PhD
[email protected]
732-235-3374
RWJBarnabas Health - Newark Beth Israel Medical CenterNewarkNew Jersey07112
Coral Omene, MD., PhD
[email protected]
732-235-3374
RWJ Barnabas Health - Robert Wood Johnson University Hospital, SomersetSomervilleNew Jersey08876
Coral Omene, MD., PhD
[email protected]
732-235-3374

Find similar trials in Elizabeth, NJ

By research site
Trinitas Comprehensive Cancer Center· Elizabeth, NJRWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton· Hamilton, NJRWJBarnabas Health - Cooperman Barnabas, Livingston· Livingston, NJRWJBarnabas Health - Monmouth Medical Center· Long Branch, NJRutgers Cancer Institute· New Brunswick, NJRWJBarnabas Health - Newark Beth Israel Medical Center· Newark, NJ

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