Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer

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.

Conditions

• Breast Cancer Stage
• Insulin Resistance
• Racial Bias

Interventions

DRUG

Metformin Extended Release Oral Tablet

initial dose of metformin of 750 mg Q.D. (with dinner) for 3-4 weeks. They then will be increased to the final dose of 750 mg BID (breakfast and dinner) until the end of the study.

Sponsors & Collaborators

• Our Lady of the Lake Hospital

  collaborator OTHER

• American Cancer Society, Inc.

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• Woman's

  lead OTHER

Principal Investigators

• Ericka Seidemann, MA · Woman's Hospital, Louisiana

• Cynthia Harper-Weinstein · Mary Bird Perkins Cancer center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-30

Primary Completion

2022-09-30

Completion

2022-09-30

FDA Drug

Yes

Countries

• United States

Study Locations