Fasting with Capivasertib in Metastatic Breast Cancer
Official title: Fast-Her: Fasting Effects on Breast Cancer Treatment
Run by University of Minnesota · NCT07624617 · Data updated 2026-11-12
This study tests whether a prolonged fasting protocol can be safely used alongside capivasertib in people with metastatic breast cancer to see if it helps treatment work.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07624617 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with histologically confirmed metastatic breast cancer currently on capivasertib therapy, with ECOG 0-1, BMI ≥25, and eligible for fasting.
✕Probably not a fit
Patients who cannot fast due to medical reasons, diabetes with poor control, pregnancy, or other contraindications to dietary changes may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study explores the tolerability and acceptability of prolonged fasting in adults with metastatic breast cancer who are receiving capivasertib. Participants will follow either a normal eating pattern or a prolonged fasting regimen, using continuous glucose monitoring and a mobile app to track intake and dietary changes. Key outcomes include feasibility, adherence, and safety, with a focus on how fasting affects the cancer treatment context. The trial is conducted at the University of Minnesota and targets patients who meet specific medical criteria and are stable on their current capivasertib dosing.
Why it matters
Potential benefit: If successful, the approach could improve how capivasertib is used and may enhance treatment compatibility through dietary strategies.
How similar studies have gone: Similar dietary interventions have shown safety and feasibility in cancer settings, but this specific fasting plus capivasertib approach is exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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University of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Lisa Chow, MD, MS — University of Minnesota
- Study coordinator: Lisa Chow, MD, MS
- Email: chow0007@umn.edu
- Phone: 612-625-8934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.