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ACTIVE NOT RECRUITING
NCT05023967
PHASE2

Metformin and Nightly Fasting in Women With Early Breast Cancer

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight.

Official title: Time Restricted Eating And Metformin (TEAM) in Invasive Breast Cancer (IBC) or Ductal Carcinoma in Situ (DCIS). A Randomized, Phase IIb, Window of Opportunity Presurgical Trial.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-04-04

Completion Date

2026-12-16

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood and tissue samples

DRUG

Extended Release Metformin Hydrochloride

Given PO

OTHER

Monitoring

Use continuous glucose monitoring system

OTHER

Nutritional Assessment

Receive nutritional counseling

OTHER

Short-Term Fasting

Perform intermittent fasting

Locations (3)

M D Anderson Cancer Center

Houston, Texas, United States

Galliera Hospital

Genoa, Italy

European Institute of Oncology

Milan, Italy