Clinical trial · Interventional
Fast-Her: Fasting Effects on Breast Cancer Treatment
NCT07624617CI-TRIAL-00117744recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal Eating | Behavioral | — | UNRESOLVED |
| Prolonged Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sequence A
- description
- 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
- interventionNames
- Behavioral: Normal Eating
- Behavioral: Prolonged Fasting
- type
- ACTIVE_COMPARATOR
- label
- Sequence B
- description
- 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
- interventionNames
- Behavioral: Normal Eating
- Behavioral: Prolonged Fasting
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.