Pioglitazone to Manage High Blood Sugar in Breast Cancer Patients on Alpelisib
Tests pioglitazone for high blood sugar in adults with breast cancer taking alpelisib.
Key facts
- Who runs it
- Rambam Health Care Campus
- Where
- Haifa, IsraelSee the site
- Trial code
- Registry title
- A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 30 people, planned
- Started
- 25 Dec 2022
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Treatments tested
- Pioglitazone
- Record updated
- 3 March 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ER-positive, HER2-negative metastatic breast cancer and a PIK3CA mutation who are about to start Alpelisib with fulvestrant.
- Age
- 18 to 85 years
- Sex
- Women only
- Disease stage
- Metastatic breast cancer that is ER positive and HER2 negative
- Earlier treatment
- Scheduled to start treatment with Alpelisib and fulvestrant
- Biomarker or test result
- An activating PIK3CA mutation
Main reasons for not taking part
- Gut disease or poor gut function that could change how Alpelisib is absorbed
- Uncontrolled diabetes (HbA1c above 8% (64 mmol/mol))
- Diabetes controlled by insulin
- Uncontrolled other illness, such as active infection or heart failure with symptoms
- Pregnancy or known allergy to pioglitazone
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant
- Ages 18 - 85
- ECOG performance status 0, 1 or 2
- Ability to understand and willingness to sign a written informed consent
Who cannot take part
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib
- Diabetes mellitus controlled by insulin
- Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known allergy to pioglitazone
- Uncontrolled diabetes mellitus, defined as HbA1c above 8%
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in Israel
- Rambam Health Care CampusHaifa, IsraelContact: Ayalet Shai, MDTaking people
About the trial
What the trial wants to find out
The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.
The group in the trial
- Treatment armTreatment being tested
treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer
Treatment: Pioglitazone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
- Plain-language title
- Pioglitazone to Manage High Blood Sugar in Breast Cancer Patients on AlpelisibGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05753657, who can take part
- Record updated
- 3 March 2023