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We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Active Comparator | Normal eating → Washout → Prolonged fasting |
|
| Sequence B | Active Comparator | Prolonged fasting → Washout → Normal eating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Fasting | Behavioral | During prolonged fasting, participants will eat only once daily (dinner), with water, black coffee and tea permitted during fasting hours. Throughout all conditions, participants will continue their prescribed PI3K inhibitor dosing. All medications will be taken at standardized times to ensure consistent pharmacokinetic measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of plasma from fasting in patients on PI3K inhibitors on cell viability | 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. | Week 2 of prolonged fasting |
| mechanisms by which fasting might enhance PI3K inhibitor efficacy through complementary molecular and cellular studies | 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. | Week 7 |
| Identify biomarkers/patient characteristics predicting the enhancement of PI3K inhibitor efficacy with fasting. | 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). | Week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Chow, MD, MS | Contact | 612-625-8934 | chow0007@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Chow, MD, MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| D017437 |
| Skin and Connective Tissue Diseases |