Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer (NCT05090358) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
United States15 participantsStarted 2021-10-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed metastatic HR-positive, HER2-negative breast cancer. HR positive is defined by ER status \>10% immunohistochemical (IHC) staining of any intensity. HER2 negativity is defined as the following as per the 2018 American Society of
Clinical Oncology and College of American Pathologists guidelines:
* IHC score of 0 or 1+ or
* Single-probe average HER2 copy number of \<4 signals/cell or
* Dual-probe HER2/CEP17 ratio \<2 with an average HER2 copy number of \<4 signals/cell or
* IHC 0, 1+, or 2+ and dual-probe HER2/CEP17 ratio ≥2 with an average HER2 copy number of \<4 signals/cell or
* IHC 0 or 1+ and dual-probe HER2/CEP17 ratio \<2 with an average HER2 copy number of ≥6 signals/cell or
* IHC 0 or 1+ and dual-probe HER2/CEP17 ratio \<2 with an average HER2 copy number of ≥4 and \<6 signals/cell.
* Presence of one or more activating PIK3CA mutations in tumor tissue.
* Measurable or non-measurable disease per RECIST v1.1 OR at least one predominantly lytic bone lesion must be present.
* Written informed consent provided
* Female or male ≥18 years of age
* Adequate archived tumor tissue for the analysis of PIK3CA mutational status or evaluable circulating tumor DNA (ctDNA) for analysis of PIK3CA mutation status
* Recurrence or progression of disease during or after endocrine-based therapy
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Life expectancy ≥6 months.
* Adequate organ and marrow functio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.