Full TitleTargeting Insulin Feedback to Enhance Alpelisib (TIFA): A Phase 2 Randomized Control Trial in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
Standard treatments for metastatic breast cancer can cause side effects such as high blood sugar (hyperglycemia). Researchers are doing this study to find out whether a very low carbohydrate diet (ketogenic diet), a low carbohydrate diet, or the drug canagliflozin can prevent high blood sugar and may improve the effectiveness of cancer therapy in people who are receiving alpelisib and fulvestrant for metastatic breast cancer that has a change (mutation) in the PIK3CA gene, which helps cancer cells to grow. Canagliflozin is already used to prevent high blood sugar in people with diabetes.
Participants in this study will be randomly assigned to one of three treatments:
- A ketogenic diet that includes less than 35 grams of carbohydrates per day. Breakfasts, lunches, dinners, and snacks will be delivered to participants weekly.
- A low carbohydrate diet that includes less than 100 grams of carbohydrates per day. Breakfasts, lunches, dinners, and snacks will be delivered to participants weekly.
- Treatment with the study drug canagliflozin.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Participants must have metastatic breast cancer that has a change (mutation) in the PIK3CA gene and receptors (binding sites) for the hormones progesterone and/or estrogen.
- Patients’ tumors must be negative for the HER2 protein.
- Prior chemotherapy for metastatic breast cancer is not allowed.
- Participants must be willing to eat meat.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, they must be well enough that they would be able to carry out office work or light housework.
- This study is for people age 18 and older.
For more information about this study and to ask about eligibility, please contact Dr. Neil Iyengar at 646-888-4714.