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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am 18 years old or older.
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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 blood tests for organ function and blood cell counts are within normal ranges.
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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 can take pills by mouth.
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I am postmenopausal.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hyperglycemia-free rate for participants

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
~440
Alpelisib
2018
Completed Phase 3
~900
Fulvestrant
2011
Completed Phase 3
~3700
Canagliflozin
2011
Completed Phase 4
~747310

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,793 Total Patients Enrolled
202 Trials studying Breast Cancer
95,154 Patients Enrolled for Breast Cancer
Neil Iyengar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
428 Total Patients Enrolled
3 Trials studying Breast Cancer
300 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05090358 — Phase 2
Breast Cancer Research Study Groups: Ketogenic Diet, Low Carbohydrate Diet, SGLT2i Therapy
Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT05090358 — Phase 2
Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090358 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Ketogenic Diet a popular research topic?

"The ketogenic diet was first put under scientific scrutiny in 2004 at Lowell General Hospital. As of right now, there have been a total of 226 completed clinical trials. Out of these, 167 are actively recruiting participants. Many of these trials are being conducted in Basking Ridge, New jersey."

Answered by AI

What are some of the benefits that patients see from following a Ketogenic Diet?

"The ketogenic diet is most popularly known for its role in breast cancer treatment, but it has also been linked with improvements in cardiovascular disease, disease progression, and exercise performance."

Answered by AI

Has the Ketogenic Diet been federally recognized?

"Given that this is a Phase 2 trial, meaning that there is only preliminary data supporting safety, our team at Power has given Ketogenic Diet a 2."

Answered by AI
~2 spots leftby Oct 2024