Metastatic Breast CancerEarly Phase 1NCT05753657
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
A Early Phase 1 study testing Pioglitazone in people with Metastatic Breast Cancer and Hyperinsulinism, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Metastatic Breast Cancer, Hyperinsulinism, Hyperglycemia Drug Induced
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Dec 2022to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
Ayalet Shai, MD, a_shai@rambam.health.gov.il
About this study
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.
Read the detailed description
- 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.
- To assess the feasibility and safety of treatment with pioglitazone in these patients.
- To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.
- To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.
- To assess the median progression free survival of patients treated according to this protocol
- Being tested
- Pioglitazone
- Medical subject headings
- Breast Neoplasms, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
hyperinsulinemia and hyperglycemia
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol
Measured: 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
Measured: through study completion, an average of 1 year
Progression free survival in patients enrolled in the study and in patients treated per protocol
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start25 Dec 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayelet Shai MD, Rambam Health Care Campus
- Investigators
- Ayelet Shai, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753657
- Sponsor's protocol ID
- 0494-22-RMB
- Status last verified
- Feb 2023
- First submitted
- 26 Dec 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05753657
- Acronym / sponsor ID
- 0494-22-RMB
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To assess the feasibility and safety of treatment with pioglitazone in these patients.
- To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.
- To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.
- To assess the median progression free survival of patients treated according to this protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Pioglitazonetreating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazonehyperinsulinemia and hyperglycemia | Drug | Treatment arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayelet Shai, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pioglitazone in people with Metastatic Breast Cancer and Hyperinsulinism, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayelet Shai, MD (+972-4-777-6700, a_shai@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.