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Fast-Her: Fasting Effects on Breast Cancer Treatment

ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Type 1 diabetes mellitus

Uncontrolled type 2 diabetes (HbA1c >9.0%)

History of severe hypoglycemia

Eating disorders or contraindications to fasting

Trial design

Design model

Crossover

Treatments tested in this trial

  • Normal Eating

    Behavioral

    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

    Behavioral

    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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Sequence AActive comparator 2 interventions
Group B: Sequence BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 2 of prolonged fasting
2

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.

Time frame
Week 7
3

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).

Time frame
Week 7

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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