Research Studies (Metformin and Longitudinal Database)

I have been asked to participate in two research studies being done at Hopkins.

1. Phase III - Randomized Trial of Metformin vs Placebo on Recurrence and Survival of Early Stage Breast Cancer - I stopped this study in April 2013 after I continued to lose weight and was unable to maintain a normal level.  I will no longer be participating in this study.  

This study will help determine whether Metformin can decrease, or affect, the ability of breast cancer cells to grow and whether this drug will work with Tamoxifen to keep cancer from recurring.  Metformin is currently being used to treat diabetes.  This study will help determine if it is better to receive Metformin with usual treatments of breast cancer.  Half the participants in this study will receive Metformin in addition to other treatments, while the other half will receive a placebo.  Previous studies of Metformin have shown that it may decrease the growth of different types of cancer cells.  Meformin lowers the level of insulin, a hormone found in the blood that can be associated with worse breast cancer outcomes.  In addition to taking Metformin, blood samples are also taken at specified times during the study.  This is a double-blind study, meaning that neither myself or my doctors will know if I am taking Metformin or a placebo.

• Common side effects (likely)
• Diarrhea
• Nausea
• Vomiting
• Abdominal bloating
• Gas
• Loss of appetite
• Less likely
• Loss of taste or metallic tastes
• Minorweight loss
• Reduced appetite
• Rarely
• Rash, redness, or itchiness
• Decrease of B12
• Anemia
• Inflammation of the liver

I will start taking either the Metformin or the placebo on 1/11 when I start taking Tamoxifen.

      2. Breast Cancer Program Hormone Therapy Longitudinal Database

This study is being done to learn more about the side effects of breast cancer hormone therapy and if a person's genetic information may help to develop a way to predict the side effects a patient may have and how best to treat them.  It will also help the researchers to look at how the side effects of hormone therapy influences a participants willingness to continue hormonal treatments.

I will be filling out questionnaires periodically that will ask spesific questions about how I am feeling, if I am taking the medication regularly, and any changes to my medication list.  I completed a base line and will fill out one at 3, 6 and 12 months.  This is all computerized, so I will be able to see what has changed and it will highlight things that are out of range.  My oncologist and myself will have access to the results, and they can be used to facilitate conversation about any issues I am having.