Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
Status:
Not yet recruiting
Trial end date:
2024-03-30
Target enrollment:
Participant gender:
Summary
Breast cancer is one of the most common malignancies in women globally, with ~1.4 million new
cases diagnosed annually Breast cancer is one of the leading causes of cancer-related
morbidity and mortality among women worldwide. While diabetes/insulin-resistance and breast
cancer are distinct diseases, insulin-signaling plays a central role in both illnesses.
Insulin activates key cancer processes including epithelial-mesenchymal transition (EMT),
tissue inflammation, motility, and angiogenesis. There are key opportunities to impact and
prevent hyperinsulinemia during breast cancer prevention, surgical assessment, and
chemotherapy. Given the high prevalence of undiagnosed pre-diabetes and diabetes in the
United States and worldwide, preoperative screening to identify such patients prior to
surgical intervention is warranted. While it is not standard of care to test for
insulin-resistance during the course of breast cancer screening and treatment, it is standard
of care to screen and test high risk women for insulin-resistance as part of whole woman
care. Given the important role insulin signaling plays in driving signaling pathways that
promote aggressive cancer biology, more attention should be paid by cancer physicians to
screening and treating insulin resistance. Several studies have reinforced a link between
breast cancer risk and diabetes. Moreover, metformin significantly reduces breast cancer
risk, compared to patients who are not using metformin and is independent of diabetes status.
As metformin has an association with decreased breast cancer recurrence, as well as
potentially improved survival, disparities in insulin resistance between black and white
women with breast cancer is important to investigate. It is hypothesized that metformin
decreases the development of resistance in breast cancer cells, thereby allowing current
chemotherapy agents to work synergistically with metformin. Our objective is to elucidate
whether or not metformin is efficacious in improving insulin resistance in black and white
women with breast cancer and if racial disparities in breast cancer prognosis can be
partially explained by differences in pre-diagnosis insulin resistance which are improved
with metformin therapy.
Phase:
Phase 4
Details
Lead Sponsor:
Woman's
Collaborators:
American Cancer Society, Inc. Our Lady of the Lake Regional Medical Center Pfizer