New Brunswick, March 31, 2025 –Obesity is a well-established risk factor for breast cancer, particularly in postmenopausal women. In fact, studies show that women with severe obesity (BMI 35+) face a 44 percent higher risk of dying from breast cancer. Excess body fat can lead to increased levels of estrogen and insulin, both of which are known to promote cancer growth. Additionally, chronic inflammation associated with obesity can contribute to the development and progression of tumors.
Doctors at Rutgers Cancer Institute and RWJBarnabas Health are studying how to tackle this problem with a first-of-its-kind clinical trial using tirzepatide, a dual GIP/GLP-1 receptor agonist weight loss drug. Titled FITWISE, this innovative trial aims to induce sustainable weight loss, improve cardiometabolic health and potentially reduce cancer recurrence during the survivorship years of patients with early-stage hormone receptor positive/Her 2 negative (HR+/Her2-) breast cancer. This is particularly important given the side effects of weight gain that women can experience with the treatment for their HR+ breast cancer
“This class of drug is making waves right now due to the multitude of health benefits attributed to these drugs,” said Dr. Coral Omene, a medical oncologist in the Breast Oncology Program at Rutgers Cancer Institute and RWJBarnabas Health and lead researcher who is overseeing the study. “Oncologists are now looking into the various ways in which these drugs can potentially benefit cancer patients. We are excited to lead the charge in researching the potential benefits of tirzepatide for women with breast cancer,” stated Dr. Omene who is also Program Director, Breast Cancer Disparities Research at Rutgers Cancer Institute.
Previous studies have shown that a 5 percent weight loss may be sufficient to reverse the metabolic disarray induced by obesity. Tirzepatide has been demonstrated to result in substantial and sustained reductions in body weight, and the team at Rutgers Cancer Institute and RWJBarnabas Health believe that the use of this medication post-treatment may result in the needed weight loss to decrease a patient’s risk of HR+/Her2- breast cancer recurrence.
Researchers have also determined that not only does obesity disproportionately affect minorities, in particular Black populations, it results in disparities in obesity related cancer diagnosis and outcomes. In fact, Black women have a roughly 41 percent higher death rate from breast cancer. The FITWISE study is designed to enroll 50 percent of the participants to be Black women. “The statistics are clear — Black women face a disproportionate burden of both obesity and breast cancer,” added Dr. Omene. “That’s why we prioritized collecting blood and tissue in this trial for analysis to directly address these disparities. One of our goals is to gather insights that can improve survival rates and outcomes for Black women battling breast cancer.”
“Clinical trials are the foundation of modern cancer treatment,” said Dr. Omene. “Trials like this one help researchers determine the safety and effectiveness of new therapies, refine existing treatments, and uncover new approaches to fighting disease. We are hopeful and confident that this trial will help pave the way for a new and potentially life-saving approach.”
FITWISE was presented at the San Antonio Breast Cancer Symposium in December 2024 and is currently enrolling patients (NCT06518837).
Support for this work is provided by the Princeton Branch of the Ludwig Institute for Cancer Research and the Hilton Foundation.
Media Contacts:
Krista Didzbalis
732.507.8307
krista.didzbalis2@rwjbh.org