Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast C… (NCT01793948) | Clinical Trial Compass
CompletedEarly Phase 1
Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer
United States24 participantsStarted 2013-04-16
Plain-language summary
This randomized clinical trial studies metformin hydrochloride in overweight or obese patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the expression of early tumor makers in breast tissue of patients at increased risk for breast cancer
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
* Patients must be post-menopausal women; post-menopausal women are defined as: (1) those \>= 50 years of age who had not menstruated during the preceding 12 months or who had castrate follicle-stimulating hormone levels (\> 40 IU/L), (2) those who had undergone a bilateral oophorectomy
* Patients must be at elevated risk for breast cancer based on strong family history or a history of breast biopsy documenting atypical hyperplasia anytime in the past; for this study strong family history is defined as having:
* 1 first-degree (parent, offspring, sibling) relative =\< 50 years old when diagnosed with breast cancer, or
* \>= 2 first-degree relatives of any age when diagnosed with breast cancer, or
* \>= 2 second-degree (aunts, uncles, grandparents, grandchildren, nieces, nephews, or half-siblings) maternal or paternal relatives diagnosed with breast cancer and at least 1 diagnosed at =\< 50 years of age
* Patients must have a body mass index (BMI) \>= 25.0 as calculated by the formula: weight in pounds / height squared x 703 = BMI; a BMI of:
* 18.5-24.9 is considered normal;
* 25.0-29.9 is considered overweight;
* 30.0+ is regarded as obese
* Patients must be willing to complete a bilateral mammogram at baseline with repeat exam after 12 cycles of protocol therapy; patients who have had a mammogram within 1 month prior to registration to protocol therapy will not need to repeat the exam
* Patients must be willing to provide a core tissue biop…
What they're measuring
1
Changes in the phosphorylation of proteins after metformin exposure