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Research & Clinical Trials > Study Search Tool > Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer

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Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer

This study is open to:

This study is open to women age 25-55 who:

  • are premenopausal
  • have a body mass index (BMI) of 25 or higher
  • at high risk for breast cancer by one or more of the following:
    • prior biopsy with atypical hyperplasia, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS)
    • Gail Model Risk of ≥1.66% over 5 years
    • strong family history of breast or ovarian cancer
    • known mutation in BRCA1 or BRCA 
  • are willing to undergo periaerolar fine needle aspirations and blood samples
This study is not open to:

Women who are not eligible:

  • have had a cancer diagnosis in the past 5 years with the exception of DCIS, non-melanoma skin cancer, carcinoma in situ of the cervix
  • have a body mass index (BMI) below 25
  • have breast implants 
  • have had bilateral mastectomy
  • are on any of the following meds: warfarin, tamoxifen, raloxifene, pyrimethamine, cimetidine, rifampin, or cephalexin
Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer

Metformin to Lower Breast Cancer Risk in High Risk Women

Clinicaltrials.gov identifier:
NCT01905046

Prevention:
Breast

Study Contact Information

Multiple sites are enrolling throughout the US in CA, KS, NY, OH, OK, SC, TX, WI. Contact Victoria Seewaldt, MD (626) 471-7321 for more information. 

About the Study

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better.

Type of Study

This is a 2-arm, randomized, placebo-controlled, double-blind study. This study allows crossover. 

  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in.
  • This is a placebo-controlled study. Placebos are harmless sugar pills. Placebos are only used in research in situations where there is no standard treatment. 
  • The study has two arms. This means that patients in the study are placed in one of two different groups. One group will received metformin and the other group will receive a placebo
  • This is a double-blind study, neither the patient in the study nor their doctor will know which group they have been assigned to until the end of the first year of therapy. At the end of the first year, all patients will be "unblinded" so that both they and their doctor will learn which medication they were on. Patients on metformin will continue the drug for another year. Patients on placebo will be allowed to crossover and take metformin for a year. 
  • The study allows crossover. This means that patients who progress on the standard treatment arm will be given the opportunity to crossover into the rucaparib arm if they choose. 

What the Study Entails

  • Women who qualify will be randomly assigned to one of two groups
    • one group will receive oral metformin daily for 24 months
    • the second group will receive a placebo daily for the first 12 months then may cross over to receive metformin daily for months 13-24.
  • Random  periaerolar fine needle aspirations will be used to look for atypical cells in both groups.
  • All patients will be followed annually for up to 2 years after the study.

Study Lead Investigator

Principal Investigator: Victoria Seewaldt, MD; City of Hope, Duarte, CA. (626) 471-7321

Study Sites

  • California, Duarte: City of Hope Cancer Center
    • Contact: Victoria Seewaldt, MD by phone: 800-826-4673 or email   
  • Kansas, Kansas City: University of Kansas Cancer Center
    • Contact: Carol Fabian, MD by phone: 913-945-7552 or email 
  • New York, New York: Columbia University/Herbert Irving Cancer Center
    • Contact: Katherine Crew, MD by phone: 212-305-8615
  • Ohio, Cincinnati: The Christ Hospital
    • Contact: Jennifer B. Manders, MD by phone: 513-585-2859
  • Ohio, Columbus: The Ohio State University Comprehensive Cancer Center
    • Contact: Lisa Yee, MD by phone: 800-293-5066 or email  
  • Oklahoma, Oklahoma City: University of Oklahoma Health Sciences Center
    • Contact: William Dooley, MD by phone: 405-271-8777 or email
  • South Carolina, Easley: Greenville Health System Cancer Institute-Easley
    • Contact: Jeffrey Giguere, MD by phone: 864-241-6251
  • South Carolina, Butternut: Greenville Health System Cancer Institute-Butternut
    • Contact: Jeffrey Giguere, MD by phone: 864-241-6251
  • South Carolina, Faris: Greenville Health System Cancer Institute-Faris
    • Contact: Jeffrey Giguere, MD by phone: 864-241-6251
  • South Carolina, Greer: Greenville Health System Cancer Institute-Greer
    • Contact: Jeffrey Giguere, MD by phone: 864-241-6251
  • South Carolina, Seneca: Greenville Health System Cancer Institute-Seneca
    • Contact: Jeffrey Giguere, MD by phone: 864-241-6251
  • South Carolina, Spartanburg: Greenville Health System Cancer Institute-Spartanburg
    • Contact: Jeffrey Giguere, MD by phone: 864-241-6251
  • Texas, Houston: MD Anderson Cancer CenterContact:
    • Contact: Therese Bevers, MD by phone: 713-792-3245
  • Wisconsin, Madison: University of Wisconsin Hospital and Clinics   
    • Contact: Lee Wilke, MD by phone: 877-405-6866   

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