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PI3K Inhibitor

Dietary Changes + Canagliflozin for Metastatic Breast Cancer

Phase 2

Waitlist Available

Led By Neil Iyengar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed metastatic HR-positive, HER2-negative breast cancer with specific criteria for HR positivity and HER2 negativity

Presence of one or more activating PIK3CA mutations in tumor tissue

Must not have

Current participation in a formalized weight loss program or currently consuming a ketogenic diet

Known hypersensitivity to alpelisib, fulvestrant, canagliflozin, or to any of the excipients of alpelisib or fulvestrant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a low-carb or ketogenic diet, or the drug canagliflozin, can help prevent high blood sugar and improve the effectiveness of cancer therapy in people with metastatic PIK3CA-mutant breast cancer who are receiving standard treatment with alpelisib and fulvestrant.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include dietary challenges like ketosis from low-carb diets. Alpelisib may cause rash or hyperglycemia; Fulvestrant could cause injection site reactions; Canagliflozin might lead to urinary tract infections or dehydration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer has a PIK3CA mutation.

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My cancer can be measured by scans or I have at least one bone lesion.

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My cancer has enough tissue or blood samples for PIK3CA mutation testing.

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My cancer came back or got worse after hormone therapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My fasting blood sugar is under 140 mg/dL, my HbA1c is below 8%, and I only take metformin for it.

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I am postmenopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in a weight loss program or on a ketogenic diet.

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I am not allergic to alpelisib, fulvestrant, canagliflozin, or their ingredients.

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I have Type 1 diabetes.

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

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I have type 2 diabetes and am treated with specific diabetes medications or insulin.

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I am unable to make decisions for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hyperglycemia-free rate for participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Carbohydrate Diet

2021

Completed Phase 2

~60

Ketogenic Diet

2016

Completed Phase 2

~460