Could a common diabetes drug and fasting shrink breast tumors before surgery?
NCT ID NCT05023967
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase IIb trial is testing whether combining a nightly fast (time-restricted eating) with the diabetes drug metformin can slow the growth of breast cancer cells before surgery. The study includes 120 women with early-stage breast cancer or a precancerous condition called DCIS. Participants will take metformin and follow a fasting schedule for a few weeks before their planned surgery, and researchers will measure changes in tumor cell growth and other biomarkers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin extended-release (a diabetes drug) plus time-restricted eating (nightly fasting)
- What this could lead to
- If it works, this could point toward a simple, low-cost way to slow breast cancer growth before surgery, possibly reducing the need for more aggressive treatments.
- What could go wrong
- This is a small, early-phase trial (phase IIb) with only 120 participants. The results may not apply to all breast cancer types, and metformin can cause side effects like low blood sugar or digestive issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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120 people
The number who actually took part.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Women with larger tumors who refuse neo-adjuvant chemotherapy before surgery can also be eligible. Luminal HER2+ve (cT1, cN0) IBC and DCIS are also eligible * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Leukocytes \>= 3,000/microliter * Absolute neutrophil count \>= 1,500/microliter * Platelets \>= 100,000/microliter * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal * Creatinine within normal institutional limits * Creatinine clearance estimated with Cockcroft-Gault formula \> 45 mL/min * Female participants of child-bearing potential must agree to use contraception such as barrier method of birth control or abstinence, prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she has to inform her study physician immediately. The effects of metformin hydrochloride extended release on the developing human fetus at the recommended therapeutic dose are unknown * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Body mass index (BMI) \< 18.5 Kg/m\^2 * Previous treatment for breast cancer including chemotherapy and endocrine therapy within the last 12 months * Women who are planned to receive neoadjuvant therapy * Triple negative breast cancer (BC) * Patients with a history of cancer within the last year. NOTE: Non melanoma skin cancer is allowed. * Documented history of symptomatic hypoglycemia * Diabetic patients or participants with fasting glucose level \>= 126 mg/dL * Known hypersensitivity or intolerance to metformin hydrochloride extended release * Participants should not be receiving any other investigational agents * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * History of lactic acidosis * Liver dysfunction including chronic active hepatitis and cirrhosis not compensated * History of vitamin B12 deficiency or megaloblastic anemia * Chronic use of large doses of diuretics (e.g., \> 80 mg furosemide) * Current use of oral hormonal contraceptives or female hormones in the last four weeks or 5 half-lives, excluding vaginal creams and intrauterine devices (IUDs) * Concomitant use of topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) * Pregnant or lactating women. Pregnant women are excluded from this study because even though published data from post-marketing studies have not reported a clear association between metformin hydrochloride extended release and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin hydrochloride extended release was used during pregnancy, these studies cannot definitely establish the absence of any metformin hydrochloride extended release associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with metformin hydrochloride extended release, breastfeeding should be discontinued if the mother is treated with metformin hydrochloride extended release. Moreover, prolonged fasting is not recommended in pregnant woman * Women who practice any type of intermittent fasting program * Women who will not have anyone available to assist them in case of need
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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European Institute of Oncology
Milan, 20141, Italy
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Galliera Hospital
Genoa, 16128, Italy
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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