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 range25 Years – 55 Years
SexFEMALE
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…
What they're measuring
1
Test for the Presence or Absence of Cytological Atypia in Unilateral or Bilateral RPFNA Aspirates After 12 Months.