Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Sequence A 		Normal eating → Washout → Prolonged fasting
  • Behavioral: Prolonged Fasting
    During prolonged fasting, participants will eat only once daily (dinner), with water, black coffee and tea permitted during fasting hours. Throughout all conditions, participants will continue their prescribed PI3K inhibitor dosing. All medications will be taken at standardized times to ensure consistent pharmacokinetic measurements.
Active Comparator
Sequence B 		Prolonged fasting → Washout → Normal eating
  • Behavioral: Prolonged Fasting
    During prolonged fasting, participants will eat only once daily (dinner), with water, black coffee and tea permitted during fasting hours. Throughout all conditions, participants will continue their prescribed PI3K inhibitor dosing. All medications will be taken at standardized times to ensure consistent pharmacokinetic measurements.

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Lisa Chow, MD, MS
612-625-8934
chow0007@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Lisa Chow, MD, MS
612-625-8934
chow0007@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.