Tirzepatide for Weight Loss Intervention in Early-Stage H... | NCT06518837

Status Module

Name	Class
Ludwig Institute for Cancer Research	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tirzepatide	Experimental	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.	Drug: Tirzepatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability of Tirzepatide for Weight Loss during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Incidence of Adverse Events Using CTCAE v5.0)	This outcome assesses the safety and tolerability of tirzepatide for weight loss in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast cancer. The primary focus is to monitor and document the incidence of adverse events (AEs) associated with tirzepatide use, utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This assessment will help determine the risk profile of tirzepatide and ensure that the benefits of weight loss outweigh potential adverse effects in this patient population.

Eligibility Module

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.

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011964	Receptors, Gastrointestinal Hormone
D018000	Receptors, Peptide