15
Participants
Start Date
October 8, 2021
Primary Completion Date
October 8, 2025
Study Completion Date
October 8, 2025
Ketogenic Diet
Properly formulated meals will be provided to both diet groups for the first 12 weeks to facilitate compliance in women with metastatic breast cancer prescribed alpelisib. After 12 weeks, subjects on the two dietary arms will be given the option to cross-over to the other diet arm and continue the prescribed dietary formulation. The decision to cross over will be per patient preference.
Low Carbohydrate Diet
Properly formulated meals will be provided to both diet groups for the first 12 weeks to facilitate compliance in women with metastatic breast cancer prescribed alpelisib. After 12 weeks, subjects on the two dietary arms will be given the option to cross-over to the other diet arm and continue the prescribed dietary formulation. The decision to cross over will be per patient preference.
Alpelisib
The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food. Patients should take their dose of PIQRAY at approximately the same time each day.
Fulvestrant
"The recommended dose is 500 mg to be administered intramuscularly into the buttocks slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days~1, 15, 29 and once monthly thereafter."
Canagliflozin
Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. For the first week of canagliflozin dosing, the dose will be 100 mg. Starting week 2 and onward the dose will be 300 mg and supplied by the site.
Memorial Sloan Kettering Cancer Center, New York
Weill Cornell Medical College (Data Collection & Data Analysis), New York
Memorial Sloan Kettering Westchester (All protocol Activities), Harrison
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activity), Commack
Ohio State University (Data Collection & Data Analysis), Columbus
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Memorial Sloan Kettering Cancer Center
OTHER