Study on Metformin for Preventing Breast Cancer in Patients with Atypical Hyperplasia or In Situ Breast Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT01905046
This clinical trial is testing whether the drug metformin can help prevent breast cancer in patients with atypical hyperplasia or in situ breast cancer. The study compares metformin to a placebo to see which is more effective in preventing cancer.
Patient Parameters
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Program Overview
The purpose of this study is to find out if metformin, a medication commonly used for diabetes, can help prevent breast cancer in patients with atypical hyperplasia or in situ breast cancer. Participants will be randomly assigned to receive either metformin or a placebo (a pill with no active medication) and will be monitored over time to see if metformin reduces the risk of developing breast cancer.
Description
The study will involve testing for changes in breast cells using a method called the Masood Cytology Index Score. This test will be done at the start of the study and after 12 and 24 months to see if there are any changes in the breast cells of women taking metformin compared to those taking a placebo. Researchers will also look at other markers in the blood and breast tissue to understand how metformin might affect breast cancer risk and other health factors like obesity and insulin resistance. Participants will have regular check-ups and tests to monitor their health and the effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have atypical hyperplasia in breast cells, confirmed by a specific test called the Masood Cytology Index Score.
- Blood tests showing:
- Hemoglobin level of at least 9 g/dL.
- Neutrophil count of at least 1500/mm³.
- Platelet count of at least 75,000/mm³.
- Creatinine level of 1.4 mg/dL or lower.
- Total bilirubin level of 3.0 mg/dL or lower.
- AST and ALT levels no more than 3 times the normal limit.
- Negative pregnancy test for women who can become pregnant.
- Women eligible for tamoxifen must have been offered it and declined.
Exclusion Criteria:
- Have had another active cancer within the last 5 years, except for certain skin or cervical cancers.
- Body mass index (BMI) less than 25.
- Taking the blood thinner Warfarin.
- Have breast implants or certain types of breast reconstruction.
- Active alcoholism.
- Allergic to metformin.
- Currently taking tamoxifen or raloxifene.
- Have taken any investigational drugs within 30 days before the study.
- Previous radiation to both breasts.
- Have serious health conditions that could interfere with the study.
- Taking certain medications like pyrimethamine, cimetidine, rifampin, or cephalexin.
- Have invasive breast cancer.
- Have taken metformin in the last 90 days.
- Have high blood sugar levels (hemoglobin A1c over 6.3) or are being treated for diabetes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Los Angeles County-USC Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| The Community Hospital | 46321 | Munster | Indiana |
| University of Kansas Cancer Center | 66160 | Kansas City | Kansas |
| Cotton O'Neil Cancer Center / Stormont Vail Health | 66606 | Topeka | Kansas |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Roswell Park Cancer Institute | 14263 | Buffalo | New York |
| Mount Sinai Hospital | 10029 | New York | New York |
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