Recruiting

Fasting with PI3K Inhibitors

Sponsor:

University of Minnesota

Code:

NCT07624617

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Normal Eating

Prolonged Fasting

Study Details

Brief 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.

Conditions

Metastatic Breast Cancer

Study ID

NCT07624617

Start date

May 18, 2026

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Sequence A

Participants randomized to Sequence A will complete a normal eating intervention period, followed by a washout period, followed by a prolonged fasting intervention period.

Normal eating → Washout → Prolonged fasting

active comparator: Sequence B

Participants randomized to Sequence B will complete a prolonged fasting intervention period, followed by a washout period, followed by a normal eating intervention period.

Prolonged fasting → Washout → Normal eating

Interventions

Normal Eating

During the normal eating intervention period, participants will follow their usual eating pattern. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.

Prolonged Fasting

During the prolonged fasting intervention period, participants will eat only once daily (dinner), with water, black coffee, and tea permitted during fasting hours. Participants will continue their prescribed PI3K inhibitor dosing, with medications taken at standardized times to ensure consistent pharmacokinetic measurements.

Primary outcome measure

  • Effect of plasma from fasting in patients on PI3K inhibitors on cell viability [ Time Frame: Week 2 of prolonged fasting ]
  • mechanisms by which fasting might enhance PI3K inhibitor efficacy through complementary molecular and cellular studies [ Time Frame: Week 7 ]
  • Identify biomarkers/patient characteristics predicting the enhancement of PI3K inhibitor efficacy with fasting. [ Time Frame: Week 7 ]

Central Contacts and Locations

Central contacts

Lisa Chow, MD, MS

612-625-8934chow0007@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Lisa Chow, MD, MS

612-625-8934chow0007@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • capivasertib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-13.