A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pioglitazone.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer, Hyperinsulinism, Hyperglycemia Drug Induced. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
1. To assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with Alpelisib for metastatic breast cancer. 2. To assess the feasibility and safety of treatment with pioglitazone in these patients. 3. To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol. 4. To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol. 5. To assess the median progression free survival of patients treated according to this protocol
Interventions
- Drug Pioglitazone
hyperinsulinemia and hyperglycemia
Primary outcome measures
- Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol [Time frame: through study completion, an average of 1 year]
- Rate of all grade hyperglycemia in patients enrolled in the study and in patients treated per protocol [Time frame: through study completion, an average of 1 year]
- Progression free survival in patients enrolled in the study and in patients treated per protocol [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib
- Uncontrolled diabetes mellitus, defined as HbA1c above 8%
- 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
- Pregnancy
- Known allergy to pioglitazone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Rambam Health Care Campus — Haifa
Identifiers
NCT: NCT05753657 · 0494-22-RMB