Dietary Changes + Canagliflozin for Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byNeil Iyengar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study to find out whether a very low carbohydrate diet (ketogenic diet), a low carbohydrate diet, or the study drug canagliflozin can prevent high blood sugar and may improve the effectiveness of cancer therapy in people who are receiving standard treatment with alpelisib and fulvestrant for their metastatic PIK3CA-mutant breast cancer.

Research Team

Neil Iyengar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with metastatic HR-positive, HER2-negative breast cancer that has PIK3CA mutations. They must have had disease progression after endocrine therapy, be able to swallow pills, and follow a strict diet. Excluded are those underweight, with certain allergies or other cancers, uncontrolled diabetes, multiple chemotherapy treatments in the metastatic setting, or on specific diets.

Inclusion Criteria

My cancer has a PIK3CA mutation.

My breast cancer is HR-positive and HER2-negative.

I am 18 years old or older.

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Exclusion Criteria

You have an allergy or intolerance to eggs, gluten, nuts, or milk that would make it hard for you to follow the diet.

My diabetes is not under control (A1c is 8.0 or higher).

Currently participating in a study of an investigational agent

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Treatment Details

Interventions

Alpelisib (PI3K Inhibitor)
Canagliflozin (SGLT2 Inhibitor)
Fulvestrant (Estrogen Receptor Antagonist)
Ketogenic Diet (Dietary Supplement)
Low Carbohydrate Diet (Dietary Supplement)

Trial OverviewThe study tests if a very low carbohydrate (ketogenic) diet, a low carbohydrate diet, or the drug canagliflozin prevents high blood sugar and improves effectiveness of standard treatment with alpelisib and fulvestrant in patients with specific breast cancer mutations.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: SGLT2i TherapyExperimental Treatment3 Interventions

Postmenopausal women and men with histologically-confirmed, HR-positive, HER2-negative, PIK3CA mutant MBC who have received no more than 1 line of endocrine-based therapy in the metastatic setting will be eligible. Participants on this arm will be assigned to SGLT2i therapy each in combination with SOC endocrine therapy (fulvestrant) and PI3K inhibition (alpelisib)

Group II: Low Carbohydrate DietExperimental Treatment4 Interventions

Postmenopausal women and men with histologically-confirmed, HR-positive, HER2-negative, PIK3CA mutant MBC who have received no more than 1 line of endocrine-based therapy in the metastatic setting will be eligible. Participants on this arm will be assigned to Low Carbohydrate Diet/LCD therapy each in combination with SOC endocrine therapy (fulvestrant) and PI3K inhibition (alpelisib)

Group III: Ketogenic DietExperimental Treatment4 Interventions

Postmenopausal women and men with histologically-confirmed, HR-positive, HER2-negative, PIK3CA mutant MBC who have received no more than 1 line of endocrine-based therapy in the metastatic setting will be eligible. Participants on this arm will partake in a ketogenic diet in combination with SOC endocrine therapy (fulvestrant) and PI3K inhibition (alpelisib)