Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 8, 2021

Primary Completion Date

October 8, 2025

Study Completion Date

October 8, 2025

Conditions
Breast CancerBreast Cancer Stage IVMetastatic Breast Cancer
Interventions
DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DRUG

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.

DRUG

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."

DRUG

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.

Trial Locations (9)

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medical College (Data Collection & Data Analysis), New York

10604

Memorial Sloan Kettering Westchester (All protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activity), Commack

43210

Ohio State University (Data Collection & Data Analysis), Columbus

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER