Clinical trial NCT05753657: A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Metastatic Breast Cancer
Hyperinsulinism
Hyperglycemia Drug Induced
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol
timeFrame: through study completion, an average of 1 year
measure: Rate of all grade hyperglycemia in patients enrolled in the study and in patients treated per protocol
timeFrame: through study completion, an average of 1 year
measure: Progression free survival in patients enrolled in the study and in patients treated per protocol
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ayelet Shai, MD
role: PRINCIPAL_INVESTIGATOR
References: