Titles and Affiliations
Susan Dwight Bliss Professor of Epidemiology
Associate Dean of Research, Yale School of Public Health
Deputy Director, Yale Cancer Center
Deputy Director of Public Health, Yale Center for Clinical Investigation
Research area
Examining the effects of exercise and nutrition therapy on patients newly diagnosed with triple-negative breast cancer
Impact
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer that can be challenging to treat. Unlike other forms of the disease, TNBC does not respond to hormone therapy or HER2-targeted treatments, leaving chemotherapy as the main treatment option. Even with chemotherapy, TNBC has a higher risk of recurrence and worse survival outcomes and is more often linked to modifiable risk factors such as obesity. This challenging landscape underscores the urgent need for innovative approaches that can safely enhance treatment effectiveness and improve patients’ quality of life. Dr. Irwin has led two clinical trials supported by BCRF, LEAN (Lifestyle, Exercise, and Nutrition) and LEANer (Lifestyle, Exercise, Nutrition Early after Diagnosis Study) testing how diet and exercise during treatment improves breast cancer outcomes.
Progress Thus Far
Dr. Irwin and her team are launching the first-ever clinical trial to test whether a structured exercise and nutrition program can improve pathologic complete response (pCR) in people undergoing chemotherapy for TNBC. pCR is the disappearance of all detectable cancer after treatment given before surgery and is closely associated with improved long-term outcomes, including lower risk of recurrence and better overall survival. This study is built on the promising results of LEANer, which showed that TNBC patients who received the exercise and nutrition intervention achieved a pCR rate of 69 percent, compared to just 30 percent with usual care. These findings suggested that the LEANer intervention may influence cancer outcomes by altering immune, inflammatory, and metabolic pathways.
What’s next
The researchers will enroll a diverse group of 160 participants diagnosed with stage II and III TNBC receiving chemo-immunotherapy before surgery over the next four years. Participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. The research team will explore if the intervention improves residual cancer burden, symptoms related to cancer treatment, body composition, and will monitor blood biomarkers and patient-reported outcomes such as fatigue and quality of life.
She will continue studying results from the LEAN and LEANer trials. The team is analyzing how the interventions affect body composition, treatment response, nerve damage, diet, and surgery results, with the goal of identifying links between biological changes and better health outcomes.
Biography
Melinda L. Irwin, PhD, MPH is the Susan Dwight Bliss Professor of Epidemiology and Associate Dean of Research at the Yale School of Public Health, Deputy Director of the Yale Cancer Center, and the Deputy Director of Public Health for the Yale Center for Clinical Investigation. Dr. Irwin is a prominent leader in cancer prevention and survivorship research: she is the principal investigator of 16 externally funded research projects in the last 19 years, serves on numerous national advisory boards related to cancer survivorship including co-chairing the national clinical trials network SWOG cancer survivorship committee, and is leading NCI-funded training programs to mentor and train the next generation of cancer researchers. The focus of her breast cancer research is on randomized controlled trials of the impact of exercise, diet, and weight loss on cancer biomarkers, treatment side effects and outcomes, and quality of life.
