Fast-Her: Fasting Effects on Breast Cancer Treatment

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

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)

Conditions3

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