Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In S… (NCT01905046) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
United States86 participantsStarted 2015-11-23
Plain-language summary
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.
Who can participate
Age range
25 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* PRE-REGISTRATION-INCLUSION CRITERIA
* Must be at increased risk for breast cancer, defined as at least one of the following four criteria:
* Having had a prior biopsy demonstrating atypical hyperplasia, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS)
* A Gail Model Risk of \>= 1.66% over 5 years
* A strong family history of breast and/or ovarian cancer which is defined as at least one of the following:
* One first-degree relative with breast cancer before the age of 50 years
* One first degree relative with bilateral breast cancer
* Two or more first-degree relatives with breast cancer
* One first degree relative and two or more second or third degree relatives with breast cancer
* One first-degree relative with breast cancer and one or more relatives with ovarian cancer
* Two second or third degree relatives with either breast cancer and one or more with ovarian cancer
* One second or third degree relative with breast cancer and two or more with ovarian cancer
* Three or more second or third degree relatives with breast cancer
* Known breast cancer (BRCA)1 or BRCA2 mutation carrier providing that the woman has
* Met with a genetic counselor to review genetic testing results, and
* Has been offered the opportunity to undergo prophylactic mastectomy and oophorectomy
* Pre-menopausal women as defined as four menstrual cycles within the last six months prior to pre-registration; women with less than 4 mens…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.