Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as a hypoglycemic event requiring permanent discontinuation of study treatment or any grade 3 or greater adverse event possibly, probably, or definitely related to the study drug.
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 |
What the registry record for NCT05023967 still lists
NCT05023967 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (66% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Anatomic Stage II Breast Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05023967's enrollment target sits among peer trials
120 30th of 73 higher than 42 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
RECRUITING · Phase 2
-
Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer
RECRUITING · Phase 2
-
Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
RECRUITING · Phase 2
-
Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
RECRUITING · Phase 2
-
Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors
RECRUITING · Phase 2
-
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01174108 · 120 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
- NCT01627301 · 120 participants · NA
Sympathetic Overactivity in Post-traumatic Stress Disorder
- NCT02025023 · 120 participants · Phase 3
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
- NCT02128906 · 120 participants · Phase 2
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI