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Anti-diabetic drug

Metformin + Fasting for Breast Cancer

Phase 2
Recruiting
Led By Andrea De Censi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Women with histologically confirmed luminal (ER+ve and/or progesterone [PgR]+ve >= 1%) operable IBC (cT1-2, cN0-1, Mx) candidate to elective surgery and not to neo-adjuvant treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4-6 weeks
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is studying the effect of fasting and metformin on breast cancer growth. Metformin is a diabetes drug that is associated with a decreased risk of cancer. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy.

Who is the study for?
This trial is for women over 18 with early-stage breast cancer (ER+ve and/or PgR+ve) who are fit for surgery but not receiving neoadjuvant therapy. They must have normal organ function, no prior breast cancer treatment, and agree to use contraception. Excluded are those with serious illnesses, low BMI, diabetes or glucose intolerance, metformin allergies, current investigational drug use, recent hormone treatments excluding IUDs/vaginal creams, pregnant/breastfeeding women, intermittent fasters.Check my eligibility
What is being tested?
The study examines the effects of extended nightly fasting combined with a diabetes medication called extended-release Metformin on reducing breast tumor growth in women at risk for or diagnosed with early-stage breast cancer. It aims to see if this combination can decrease cell proliferation without causing weight loss.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea due to Metformin; risks associated with fasting such as dizziness or weakness; and possibly vitamin B12 deficiency from long-term Metformin use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am a woman with a certain type of breast cancer (ER+ or PgR+) that is still operable.
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My kidneys are functioning well enough to clear waste.
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I have a large tumor and chose not to have chemotherapy before surgery.
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I am mostly active and can care for myself.
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I agree to use birth control or abstain from sex during the study.
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My breast cancer is early stage, HER2 positive, and hasn't spread to lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4-6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pre-post treatment Ki67 labeling index in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) (in the absence of IBC)
Difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67 between arms
Frequency of occurrence of dose limiting toxicity
Secondary outcome measures
Alcohol consumption
Change in circulating biomarkers
Change of CIP2A-PP2A-GSK3beta-MCL-1 axis in cancer tissue
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (fasting, glucose monitoring, counseling, metformin)Experimental Treatment5 Interventions
Patients fast for >= 16 hours every night and use the continuous glucose monitoring system for 4-6 weeks. Patients also receive nutritional counseling sessions on days 0 and 10. Beginning week 2, patients also receive metformin hydrochloride extended release PO QD until the day of surgery. Treatment continues for 4-6 weeks (until surgery) in the absence of disease progression or unacceptable toxicity. Patients undergo the collection of blood samples at baseline and at the final study visit (days 28-43), and the collection of tissue at the time of surgery (days 28-43).
Group II: Arm II (glucose monitoring)Active Control2 Interventions
Patients continue their usual dietary pattern and use the continuous glucose monitoring system for 4-6 weeks (until surgery). Patients undergo the collection of blood samples at baseline and at the final study visit (days 28-43), and the collection of tissue at the time of surgery (days 28-43).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~1850

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,946 Previous Clinical Trials
1,803,362 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,586 Previous Clinical Trials
41,242,106 Total Patients Enrolled
938 Trials studying Breast Cancer
1,542,336 Patients Enrolled for Breast Cancer
Andrea De CensiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
350 Total Patients Enrolled

Media Library

Metformin Hydrochloride Extended Release (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT05023967 — Phase 2
Breast Cancer Research Study Groups: Arm I (fasting, glucose monitoring, counseling, metformin), Arm II (glucose monitoring)
Breast Cancer Clinical Trial 2023: Metformin Hydrochloride Extended Release Highlights & Side Effects. Trial Name: NCT05023967 — Phase 2
Metformin Hydrochloride Extended Release (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023967 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is participation allowed in this clinical experiment?

"Unfortunately, this trial is no longer enrolling patients. Initial posting was on January 30th 2023 and the last update was recorded August 17th 2022. For those still looking to participate in a clinical study, there are currently 4610 trials recruiting for breast-related topics and 170 studies related to Nutritional Assessment with open enrollment slots."

Answered by AI

How has Nutritional Assessment been traditionally employed for clinical purposes?

"Nutritional Assessment can be an effective modality for managing exercise-related issues, type 1 diabetes mellitus, and diabetic ketoacidosis."

Answered by AI

Is the procedure of Nutritional Assessment considered a safe practice for patients?

"Although there is no data regarding the efficacy of Nutritional Assessment, existing safety studies have enabled us to assign it a score of 2."

Answered by AI

What is the principal aim of this research project?

"The main endpoint of this experiment, to be measured within a span of 4-6 weeks from the Baseline, is to ascertain any Differences in adjacent DCIS (in presence of IBC) or intraepithelial neoplasia Ki67. Additionally, Alcohol consumption will be correlated with response biomarkers; Difference of M30 and Change in circulating biomarkers such as Homeostatic model assessment index, highly sensitive C-reactive protein, C-peptide etc., shall also be evaluated between arms. ANCOVA models will analyse associations among post values (after treatment), changes from baseline by study arms adjusting for baseline values"

Answered by AI

Have any prior experiments sought to evaluate the impact of nutrition on health?

"Presently, 170 different research studies are active in the field of Nutritional Assessment. Of these ongoing trials, 43 are at Phase 3 status. Although a majority of those experiments taking place in Pittsburgh, Pennsylvania, 1903 medical sites across the world have trialled this therapy."

Answered by AI

Are individuals currently able to join this trial?

"Unfortunately, this trial is no longer enrolled in the recruitment phase. It was initially advertised on January 30th 2023 and last updated August 17th 2022. There are presently 4610 studies looking for participants with breast-related conditions and 170 clinical trials relating to Nutritional Assessment that you could consider instead."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~77 spots leftby Nov 2025