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Fast-Her: Fasting Effects on Breast Cancer Treatment

Recruiting

Who can join

Ages 18 and older · All sexes

Full 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)

About the 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.

What is being tested

Sponsor: University of Minnesota · Participants: 15 · Started: May 18, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07624617

Locations in the U.S.

MinnesotaUniversity of Minnesota, Minneapolis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.