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Trial Title:
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
NCT ID:
NCT05753657
Condition:
Metastatic Breast Cancer
Hyperinsulinism
Hyperglycemia Drug Induced
Conditions: Official terms:
Breast Neoplasms
Hyperglycemia
Hyperinsulinism
Pioglitazone
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pioglitazone
Description:
hyperinsulinemia and hyperglycemia
Arm group label:
Treatment arm
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
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rambam Health Care Campus
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Ayalet Shai, MD
Email:
a_shai@rambam.health.gov.il
Start date:
December 25, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Rambam Health Care Campus
Agency class:
Other
Source:
Rambam Health Care Campus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05753657
