Metformin for Breast Cancer Prevention

Recruiting at27 trial locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.

Research Team

Victoria Seewaldt, MD

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for women at high risk for breast cancer due to factors like a history of certain breast conditions, a strong family history of breast or ovarian cancer, or known BRCA1/2 mutations. Participants must have normal blood counts and organ function, not be pregnant or breastfeeding, and willing to use birth control if menstruating. They should not have had metformin recently, no other active cancers (with some exceptions), and cannot be on specific medications like Warfarin.

Inclusion Criteria

Willing to provide RPFNA and blood samples for correlative research purposes

I am eligible for tamoxifen but have chosen not to take it.

Your AST blood test result is not more than three times the upper limit of normal.

Exclusion Criteria

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

You are currently diagnosed with alcoholism.

I have taken metformin in the last 90 days.

Treatment Details

Interventions

• Metformin Hydrochloride (Biguanide)
• Placebo (Chemoprevention)

Trial Overview The study is testing whether metformin hydrochloride can prevent the development of breast cancer in patients with atypical hyperplasia or in situ breast cancer compared to a placebo. It's a phase III trial where participants are randomly assigned to either the drug group or the placebo group.

Participant Groups

Group I: Arm I: metformin hydrochloride Experimental Treatment 1 Intervention

Patients receive metformin hydrochloride PO QD or BID for 24 months. Patients will continue metformin 850 mg PO BID for months 13-24. Patients will undergo RPFNA at 24 months. Follow up visits will be performed at 36 and 48 months after the start of treatment.

Group II: Arm II: placebo Placebo Group 1 Intervention

Patients receive placebo PO QD or BID for 12 months. Patients may crossover to Arm I for months 13-24.

Metformin Hydrochloride is already approved in Canada, Japan for the following indications:

Approved in Canada as Metformin Hydrochloride for:

• Type 2 diabetes
• Polycystic ovary syndrome

Approved in Japan as Metformin Hydrochloride for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School