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Metformin for Breast Cancer Prevention
Study Summary
This trial compares metformin to placebo to see if it can prevent breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 3649 Patients • NCT01101438Trial Design
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Who is running the clinical trial?
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- You are currently diagnosed with alcoholism.I have taken metformin in the last 90 days.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.I haven't had cancer, except for non-melanoma skin cancer or cervical pre-cancer, in the last 5 years.Women who can have children must have a negative pregnancy test within 7 days before joining the study.You weigh less than what is considered healthy for your height.I am currently taking Warfarin.I am currently taking tamoxifen or raloxifene.Your hemoglobin level is at least 9 grams per deciliter.Your creatinine level in the blood is no higher than 1.4 milligrams per deciliter.Your total bilirubin level must be less than or equal to 3.0 mg/dL.I have had breast reconstruction with implants or my own tissue.I am allergic to metformin.I have had radiation therapy on both breasts.I am currently taking pyrimethamine, cimetidine, rifampin, or cephalexin.My hemoglobin A1c is above 6.3 or I am being treated for diabetes.I am at high risk for breast cancer due to my medical or family history.I carry a BRCA1 or BRCA2 mutation and have discussed my options with a genetic counselor.I am considered pre-menopausal based on my recent menstrual cycles or hormone levels.My last mammogram was normal or showed no signs of invasive breast cancer.I am not pregnant or breastfeeding and have been using birth control if I am menstruating.My breast test score is 14-17 and was sent to Dr. Seewaldt's lab within the last 3 months.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your ALT level in the blood should be no more than three times the upper limit of normal.You must have at least 75,000 platelets per cubic millimeter of blood.I have had a biopsy showing invasive cancer.You have a sufficient number of a type of white blood cell called neutrophils.
- Group 1: Arm I: metformin hydrochloride
- Group 2: Arm II: placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you tell me about other research conducted using metformin hydrochloride?
"First studied in 2002 at George Washington University, metformin hydrochloride has had 3733 completed trials as of now. There are 180 active clinical trials being conducted with a notable hub of studies in Topeka, Wisconsin."
If an elderly person meets the other requirements, can they join this experiment?
"According to the age guidelines set out in the clinical trial's inclusion criteria, the youngest patients that can enroll are 25 years old whereas the oldest patients that can enroll are 55 years old."
Can I become a subject in this research project?
"We are looking for 161 participants, aged 25-55, who have ductal breast carcinoma in situ. Additionally, participants must meet the following criteria: -Two second or third degree relatives with either breast cancer and one or more with ovarian cancer-One first-degree relative with breast cancer and one or more relatives with ovarian cancer-PRE-REGISTRATION-INCLUSION CRITERIA-Having had a prior biopsy demonstrating atypical hyperplasia, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS)-A"
Could you please provide the total number of participants for this trial?
"As of right now, this particular trial is not looking for any more participants. The original posting date was February 1st, 2015, with the most recent update happening on August 2nd, 2022. 4863 clinical trials for ductal breast carcinoma in situ and 180 trials for metformin hydrochloride are still recruiting patients if you are interested in exploring other options."
Has metformin hydrochloride undergone FDA approval process?
"There is both prior clinical data supporting metformin hydrochloride's safety and efficacy, so it received a score of 3."
Can you explain what conditions metformin hydrochloride is meant to manage?
"Metformin hydrochloride can be used to manage type 1 diabetes mellitus, diabetic ketoacidosis, and help patients that want to improve their cardiovascular health through exercise."
Are there any unfilled vacancies for people who want to participate in this research?
"The trial in question is not presently looking for candidates, as per the information on clinicaltrials.gov. This study was originally posted on 2015-02-01 and was last updated on 2022-08-02. There are, however, 5043 other clinical trials that are currently enrolling patients."
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