NCT07624617

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Metastatic Breast Cancer

Keywords

capivasertib

Outcome Measures

Primary Outcomes (3)

  • Effect of plasma from fasting in patients on PI3K inhibitors on cell viability

    We will culture 2D/3D breast cancer models using plasma from patients in the fed and fasted states. We will assess tumor cell viability by measuring cell proliferation, apoptosis, and cell cycle distribution.

    Week 2 of prolonged fasting

  • mechanisms by which fasting might enhance PI3K inhibitor efficacy through complementary molecular and cellular studies

    We will culture 2D/3D breast cancer models using plasma from patients in the fed and fasted states and perform metabolomic and proteomic analyses to evaluate the effects on insulin and PI3K pathways.

    Week 7

  • Identify biomarkers/patient characteristics predicting the enhancement of PI3K inhibitor efficacy with fasting.

    We will evaluate biomarkers that may predict the influence of fasting on PI3K inhibitor efficacy. Using serial plasma samples, we will analyze PI3K inhibitor pharmacokinetics, metabolic markers (e.g., insulin, glucose), circadian markers (melatonin, cortisol), and tumor-specific markers (circulating tumor DNA).

    Week 7

Study Arms (2)

Sequence A

ACTIVE COMPARATOR

Normal eating → Washout → Prolonged fasting

Behavioral: Prolonged Fasting

Sequence B

ACTIVE COMPARATOR

Prolonged fasting → Washout → Normal eating

Behavioral: Prolonged Fasting

Interventions

Prolonged FastingBEHAVIORAL

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.

Sequence ASequence B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lisa Chow, MD, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Chow, MD, MS

CONTACT

612-625-8934chow0007@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 3, 2026

Record last verified: 2026-05

Locations

US(1)