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Fast-Her: Fasting Effects on Breast Cancer Treatment

NCT07624617 · University of Minnesota
In plain English

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About this study
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.
Eligibility criteria
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)
Study design
Enrollment target: 15 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-18
Estimated completion: 2027-07-01
Last updated: 2026-07-13
Interventions
Behavioral: Normal EatingBehavioral: Prolonged Fasting
Primary outcomes
  • Effect of plasma from fasting in patients on PI3K inhibitors on cell viability (Week 2 of prolonged fasting)
  • mechanisms by which fasting might enhance PI3K inhibitor efficacy through complementary molecular and cellular studies (Week 7)
  • Identify biomarkers/patient characteristics predicting the enhancement of PI3K inhibitor efficacy with fasting. (Week 7)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactLisa Chow, MD, MS · contact · chow0007@umn.edu · 612-625-8934
InvestigatorLisa Chow, MD, MS · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Fast-Her: Fasting Effects on Breast Cancer Treatment · TrialPath