Phase 2 Breast Cancer Trial, Recruiting NCT06518837 Sponsor: Rutgers, The State University of New Jersey Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06518837
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to sign a written consent form for the trial.
  • Men or women aged 18 years or older.
  • People who have been diagnosed by biopsy with a specific type of breast cancer called hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer, based on specific laboratory test results.
  • People whose breast cancer is early-stage (Stage I, II, or III) and has not previously been treated.
  • People who have already completed definitive treatment aimed at curing their breast cancer, which may have included surgery, chemotherapy, and/or radiation therapy as appropriate.
  • People with a body mass index (BMI) of 30 or above, or a BMI of 27 or above alongside at least one weight-related health condition (such as high blood pressure, type 2 diabetes, high cholesterol, sleep apnea, or heart disease).
  • People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are able to carry out at least some daily activities (confirm with trial site).
  • People whose heart is pumping at 50% efficiency or above, as measured by a heart scan done at the screening stage.
  • People whose liver, kidneys, and other organs are functioning adequately, as shown by blood tests at screening.
  • People who have stored tumour tissue samples (either tissue blocks or prepared slides) available from a previous biopsy or surgery.

Who may not be able to join:

  • People who are currently enrolled in, or planning to join, another clinical study that involves experimental treatments or procedures at the same time.
  • People whose breast cancer has spread to other parts of the body (Stage IV or metastatic breast cancer).
  • People whose breast cancer is HER2-positive or triple-negative breast cancer.
  • People who currently have another active cancer diagnosis.
  • People whose general health and activity level is rated above 2 on the standard ECOG scale, meaning their daily functioning is significantly limited.
  • People with a BMI below 27.
  • People who have Type 1 diabetes.
  • People who have a known significant problem with their stomach emptying (such as severe gastroparesis or gastric outlet obstruction), or who have been regularly taking medications that affect how the digestive system moves food through the body.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Coral Omene, MD., PhD, Rutgers Cancer Institute

Phone: 732-235-3374

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Rutgers, The State University of New Jersey
Registry
ClinicalTrials.gov
Start date
30 October 2024
Est. completion
30 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Weight Loss Reduction with Tirzepatide during Adjuvant Treatment for HR+/Her2- Breast Cancer (Measured by Body Weight Reduction)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov