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NCT05023967 · ClinicalTrials.gov registry record · Phase 2
Metformin and Nightly Fasting in Women With Early Breast Cancer
A Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT05023967 is a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05023967, a Phase 2 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Monitoring
- DRUG Extended Release Metformin Hydrochloride
- OTHER Nutritional Assessment
- OTHER Short-Term Fasting
Study Locations (3)
Other
- Galliera Hospital - Genoa
- European Institute of Oncology - Milan
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2026-12-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05023967
The ClinicalTrials.gov registry entry for NCT05023967 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (66% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05023967 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.
Frequently Asked Questions
What is clinical trial NCT05023967 about?
NCT05023967 is a clinical study titled "Metformin and Nightly Fasting in Women With Early Breast Cancer". This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabete...
What is the current status of trial NCT05023967?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-04-04. Estimated completion is 2026-12-16.
What conditions does trial NCT05023967 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Invasive Breast Carcinoma, Breast Ductal Carcinoma In Situ.
What interventions are being tested in trial NCT05023967?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Monitoring (OTHER), Extended Release Metformin Hydrochloride (DRUG), Nutritional Assessment (OTHER), Short-Term Fasting (OTHER).
Who is sponsoring clinical trial NCT05023967?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05023967 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.