Trial Title:
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
NCT ID:
NCT06518837
Condition:
Hormone Receptor-Positive Breast Cancer
HER2-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Weight Loss
Tirzepatide
Conditions: Keywords:
Weight Loss
Body Weight Reduction
Feasibility of Weight Loss Intervention
invasive Disease-Free Survival (IDFS)
Body Mass Index (BMI)
Body Fat Distribution
Metabolic Markers
Circulating Tumor DNA (ctDNA)
Tirzepatide
GIP and GLP-1 dual agonist
Black patients
distant relapse-free survival (DRFS)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Tirzepatide will be administered subcutaneously in the stomach, upper arm, or thigh.
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.
20 Black and 20 Non-Black breast cancer patients will be enrolled. More black patients
will be enrolled to enrich this cohort with the population that has an established
significant disparity in HR+ breast cancer and obesity related outcomes.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tirzepatide
Description:
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.
Arm group label:
Tirzepatide
Other name:
LY3298176 (development code name)
Other name:
Mounjaro (brand name in certain regions)
Other name:
Zepbound (brand name in certain regions)
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).
Detailed description:
The primary objective of this clinical trial is to determine the proportion of patients
who achieve a 5% or greater reduction in body weight by the end of the study treatment
with tirzepatide, during adjuvant treatment for hormone receptor-positive, HER2-negative
(HR+/Her2-) breast cancer. Secondary objectives include assessing the safety and
tolerability of tirzepatide for weight loss during this treatment. The feasibility of
using tirzepatide for weight loss intervention will be evaluated through discontinuation
rates and completion of the treatment course. Additionally, the trial will determine the
3-year invasive disease-free survival (IDFS) and 3-year distant relapse-free survival
(DRFS) with the use of tirzepatide. The study will also assess changes in Body Mass Index
(BMI), body fat distribution (measured via Waist/Hip Ratio (WHR) and waist
circumference), and obesity-related metabolic markers (including Blood Pressure, fasting
insulin, fasting blood glucose, HgbA1c, cholesterol, LDL, HDL, triglycerides, IGF1,
estrogen, and testosterone). Finally, the trial will monitor for circulating tumor DNA
(ctDNA) and assess changes when using tirzepatide for weight loss in the adjuvant
treatment of HR+/Her2- breast cancer. Quality of Life assessments will be obtained and
exploratory objectives investigating adipokines (adiponectin, leptin) and their
receptors, metabolomic pathways and immune cell metabolism will be conducted.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Consent: Be willing and able to provide written informed consent for the trial.
- Age: Male or Female patients aged 18 years or older.
- Breast Cancer Diagnosis: Have hormone receptor-positive (HR+), HER2-negative (HER2-)
breast cancer previously diagnosed by biopsy. HR status is defined as estrogen
receptor (ER) >10% and/or progesterone receptor (PR) >10%; HER2 status is defined as
immunohistochemistry (IHC) 0 or 1+ or IHC 2+, fluorescence in situ hybridization
(FISH) negative.
- Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or
III hormone receptor-positive breast cancer.
- Definitive Treatment: Have had definitive treatment with curative intent for breast
cancer, including surgery, chemotherapy, and radiotherapy as indicated.
- Body Mass Index (BMI): Have a BMI of 30 kg/m² or more, or a BMI of 27 kg/m² or more
with one weight-related complication (e.g., hypertension, type 2 diabetes,
dyslipidemia, obstructive sleep apnea, or cardiovascular disease).
- Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 to 2.
- Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% or
greater, or greater than the institution's lower limit of normal (LLN), as assessed
by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at
screening.
- Organ Function: Demonstrate adequate organ function in screening labs.
- Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumor
blocks or unstained slides.
Exclusion Criteria:
- Other Clinical Studies: Is currently enrolled, or will enroll in, a different
clinical study in which investigational therapeutic procedures are performed or
investigational therapies are administered while participating in this study.
- Stage IV Breast Cancer: Have stage IV, metastatic breast cancer.
- Cancer Type: Have HER2-positive or triple-negative breast cancer.
- Active Malignancy: Have a concomitant active malignancy.
- Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance
status greater than 2.
- Body Mass Index: Have a BMI of less than 27 kg/m².
- Type 1 Diabetes Mellitus: Have type 1 diabetes mellitus.
- Gastric Emptying Abnormality: Have a known clinically important gastric emptying
abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or
chronically took drugs that directly affect gastrointestinal motility.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Trinitas Comprehensive Cancer Center
Address:
City:
Elizabeth
Zip:
07202
Country:
United States
Contact:
Last name:
Coral Omene, MD.,PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Facility:
Name:
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Hamilton
Address:
City:
Hamilton
Zip:
08690
Country:
United States
Contact:
Last name:
Coral Omene, MD.,PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Cooperman Barnabas, Livingston
Address:
City:
Livingston
Zip:
07039
Country:
United States
Contact:
Last name:
Coral Omene, MD.,PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Monmouth Medical Center
Address:
City:
Long Branch
Zip:
07740
Country:
United States
Contact:
Last name:
Coral Omene, MD., PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Facility:
Name:
Rutgers Cancer Institute
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Contact:
Last name:
Coral Omene,, MD.PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health - Newark Beth Israel Medical Center
Address:
City:
Newark
Zip:
07112
Country:
United States
Contact:
Last name:
Coral Omene, MD., PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Facility:
Name:
RWJ Barnabas Health - Robert Wood Johnson University Hospital, Somerset
Address:
City:
Somerville
Zip:
08876
Country:
United States
Contact:
Last name:
Coral Omene, MD., PhD
Phone:
732-235-3374
Email:
co273@cinj.rutgers.edu
Start date:
September 30, 2024
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Collaborator:
Agency:
Ludwig Institute for Cancer Research
Agency class:
Other
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06518837
