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NCT05090358 · ClinicalTrials.gov registry record · Phase 2
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
A Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 9
- Study locations
NCT05090358: Active Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05090358 is a Phase 2 study of Breast Cancer and Metastatic Breast Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 15 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05090358, a Phase 2 study of Breast Cancer and Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Primary Outcome
To determine the grade 3/4 hyperglycemia-free rate at 12 weeks, as assessed by the NCI CTCAE v5.0
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Alpelisib
- DIETARY_SUPPLEMENT Ketogenic Diet
- DIETARY_SUPPLEMENT Low Carbohydrate Diet
- DRUG Canagliflozin
Study Locations (9)
New York
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activity) - Commack
- Memorial Sloan Kettering Westchester (All protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical College (Data Collection & Data Analysis) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- 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
Ohio
- Ohio State University (Data Collection & Data Analysis) - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2026-10-08 |
| Phase | Phase 2 |
What the registry record for NCT05090358 still lists
NCT05090358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.
NCT05090358 lists 9 locations in 3 states (New York, New Jersey, Ohio).
Frequently Asked Questions
What is clinical trial NCT05090358 about?
NCT05090358 is a clinical study titled "Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer". 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 ful...
What is the current status of trial NCT05090358?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-10-08. Estimated completion is 2026-10-08.
What conditions does trial NCT05090358 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Breast Cancer Stage IV.
What interventions are being tested in trial NCT05090358?
The interventions under investigation include: Fulvestrant (DRUG), Alpelisib (DRUG), Ketogenic Diet (DIETARY_SUPPLEMENT), Low Carbohydrate Diet (DIETARY_SUPPLEMENT), Canagliflozin (DRUG).
Who is sponsoring clinical trial NCT05090358?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05090358 being conducted?
This trial has 9 study locations across New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05090358's enrollment target sits among peer trials
15 1144th of 1224 higher than 72 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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