Using metformin and nightly fasting to treat early breast cancer in women
Time Restricted Eating And Metformin (TEAM) in Invasive Breast Cancer (IBC) or Ductal Carcinoma in Situ (DCIS). A Randomized, Phase IIb, Window of Opportunity Presurgical Trial.
This study is testing if taking metformin and doing nightly fasting can help women with early-stage breast cancer by slowing down tumor growth and improving health markers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT05023967 on ClinicalTrials.gov |
What this trial studies
This phase IIb trial investigates the combined effects of prolonged nightly fasting and metformin hydrochloride extended release on reducing breast tumor cell proliferation and other cancer biomarkers. The study aims to assess the safety of this intervention and evaluate its impact on post-treatment cancer tissue and circulating biomarkers. Participants will include women with operable early-stage breast cancer, and the study will monitor various health indicators and cancer responses throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with histologically confirmed operable early-stage breast cancer.
Not a fit: Patients with advanced breast cancer or those requiring immediate chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method to reduce breast cancer growth and improve outcomes for women at risk of breast cancer.
How similar studies have performed: While the combination of metformin and fasting is a novel approach, previous studies have indicated potential benefits of metformin in cancer treatment, suggesting a promising avenue for exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Women who are planned to receive neoadjuvant therapy (HER2+ve T2 or N+ve IBC or women \< 50 years with luminal B IBC) * Triple negative breast cancer (BC) * 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 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
Where this trial is running
Houston, Texas and 2 other locations
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Galliera Hospital — Genoa, Italy (Recruiting)
- European Institute of Oncology — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Parijatham Thomas, MD — M.D. Anderson Cancer Center
- Study coordinator: Parijatham Thomas, MD
- Email: psthomas@mdanderson.org
- Phone: 713-745-1075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.