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Anti-diabetic drug

Metformin + Fasting for Breast Cancer

Phase 2

Recruiting

Led By Parijatham Thomas, MD

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

Creatinine clearance estimated with Cockcroft-Gault formula > 45 mL/min

Must not have

Women who will not have anyone available to assist them in case of need

Body mass index (BMI) < 18.5 Kg/m^2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4-6 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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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My kidneys are functioning well enough to clear waste.

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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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I am mostly active and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have someone to help me if needed.

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My BMI is under 18.5.

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I am a woman under 50 with a specific type of breast cancer and planned for initial treatment.

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My breast cancer is triple negative.

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I have had chemotherapy and hormone therapy for breast cancer.

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I am not pregnant.

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I am diabetic or my fasting blood sugar is 126 mg/dL or higher.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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My liver is not working well due to chronic conditions.

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I have a history of experiencing symptoms due to low blood sugar.

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I have had lactic acidosis in the past.

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I have had vitamin B12 deficiency or megaloblastic anemia.

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I am not taking topiramate or similar medications.

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I regularly take more than 80 mg of water pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4-6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 3

~2030

0 / 18Eligibility criteria met