Fasting Effects on Metastatic Breast Cancer Treatment with PI3K Inhibitors
This study is looking at whether prolonged fasting can make a PI3K inhibitor called capivasertib work better for people with metastatic breast cancer (cancer that has spread). You would either follow your usual eating pattern or eat only dinner once a day, while continuing your capivasertib medication. Researchers want to see if fasting helps the medication fight cancer cells more effectively and if it's something patients can do. They will also look for signs in your body (biomarkers) that might predict who would benefit most from fasting. This study plans to include 15 participants and its current status is unclear.
- Study design
- This study is an interventional study, meaning participants will receive a specific treatment or intervention. It plans to enroll 15 participants.
- What's involved
- You would either follow your usual eating pattern or eat only once daily (dinner) for a period, while continuing your prescribed capivasertib. Medications will be taken at standardized times.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures effects at Week 2 of prolonged fasting and at Week 7 for other outcomes.
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Fast-Her: Fasting Effects on Breast Cancer Treatment
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lisa Chow, MD, MS · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
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Inclusion
Exclusion
What this trial measures
- Effect of plasma from fasting in patients on PI3K inhibitors on cell viabilityWeek 2 of prolonged fasting
We will culture 2D/3D breast cancer models using plasma from patients in the fed and fasted states. We will assess tumor cell viability by measuring cell proliferation, apoptosis, and cell cycle distribution.
- mechanisms by which fasting might enhance PI3K inhibitor efficacy through complementary molecular and cellular studiesWeek 7
We will culture 2D/3D breast cancer models using plasma from patients in the fed and fasted states and perform metabolomic and proteomic analyses to evaluate the effects on insulin and PI3K pathways.
- Identify biomarkers/patient characteristics predicting the enhancement of PI3K inhibitor efficacy with fasting.Week 7
We will evaluate biomarkers that may predict the influence of fasting on PI3K inhibitor efficacy. Using serial plasma samples, we will analyze PI3K inhibitor pharmacokinetics, metabolic markers (e.g., insulin, glucose), circadian markers (melatonin, cortisol), and tumor-specific markers (circulating tumor DNA).