Metastatic Breast Cancer
Conditions
Keywords
capivasertib
Brief summary
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.
Interventions
BEHAVIORALNormal Eating
During the normal eating intervention period, participants will follow their usual eating pattern. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.
BEHAVIORALProlonged Fasting
During the prolonged fasting intervention period, participants will eat only once daily (dinner), with water, black coffee, and tea permitted during fasting hours. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Histologically confirmed metastatic breast cancer * Menopausal or medically ovarian suppressed * Currently receiving capivasertib therapy (2 tablets twice daily, 4 days per week) * Stable on current capivasertib regimen for at least 2 weeks * an ECOG performance status of 0-1 * BMI ≥25kg/m2 * Able to provide informed consent * Willing to comply with study procedures including CGM wear, food tracking by mCC app and dietary modifications * Access to smartphone or tablet for mobile application use
Exclusion criteria
* Type 1 diabetes mellitus * Uncontrolled type 2 diabetes (HbA1c \>9.0%) * History of severe hypoglycemia * Eating disorders or contraindications to fasting * Pregnancy or breastfeeding * Significant gastrointestinal disorders affecting food absorption * Unable to fast for medical reasons * Concurrent participation in other dietary intervention studies * A history of significantly abnormal lab results within 4 weeks of consent date, such as hematologic (Hgb \< 10.0, platelets \< 100), hepatic (LFTs \> 2X nl), renal (Cr \> 1.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of plasma from fasting in patients on PI3K inhibitors on cell viability | Week 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 studies | Week 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). |
Countries
United States
Contacts
CONTACTLisa Chow, MD, MS
PRINCIPAL_INVESTIGATORLisa Chow, MD, MS
University of Minnesota
Outcome results
None listed