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NCT07624617
Fast-Her: Fasting Effects on Breast Cancer Treatment
Conditions: Metastatic Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: University of Minnesota
Location: University of Minnesota Minneapolis Minnesota
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.
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)
Source: ClinicalTrials.gov (NCT07624617). StuddyBuddy aggregates publicly available trial information.