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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.
EU CTIS ID: 2024-518402-40-00
What this study is testing
Primary interim objective: assess the safety of the experimental intervention based on the frequency of occurrence of a Dose Limiting Toxicity (DLT) in the first 14 participants assigned to the experimental treatment arm. A DLT is defined as a hypoglycemic event requiring permanent discontinuation of study treatment or any grade 3 or greater adverse event (AE) possibly, probably, or definitely related to the study drug. Primary objective: assess the effect of the combination of prolonged nightly fasting (>=16 hours) and Metformin on the change of Ki67 labeling index (LI) in cancer tissue (IBC or DCIS, if IBC is absent) between pre-treatment biopsy and post treatment surgical specimen. Co-primary objective: evaluate the difference in post-treatment Ki67 LI in cancer adjacent DCIS (in the presence of IBC) or IEN, defined as atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS), between the active treatment and the control group.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women with histologically confirmed ER+ve and/or 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. ER+ve and/or PgR+ve ≥1% , HER2+ve (cT1, cN0) IBC and DCIS are also eligible.
- Age ≥ 18 years
- ECOG performance status ≤1 (Karnofsky ≥70%)
- Participants must have normal organ and marrow function as defined below: Leukocytes ≥3,000/microliter Absolute neutrophil count ≥1,500/microliter Platelets ≥100,000/microliter AST (SGOT)/ALT (SGPT) ≤1.5 × institutional upper limit of normal Creatinine clearance estimated > 45 mL/min with Cockcroft-Gault formula
- 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.
You likely can't join if
- BMI < 18.5 Kg/m2.
- 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)
See the full eligibility criteria
- Women with histologically confirmed ER+ve and/or 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. ER+ve and/or PgR+ve ≥1% , HER2+ve (cT1, cN0) IBC and DCIS are also eligible.
- Age ≥ 18 years
- ECOG performance status ≤1 (Karnofsky ≥70%)
- Participants must have normal organ and marrow function as defined below: Leukocytes ≥3,000/microliter Absolute neutrophil count ≥1,500/microliter Platelets ≥100,000/microliter AST (SGOT)/ALT (SGPT) ≤1.5 × institutional upper limit of normal Creatinine clearance estimated > 45 mL/min with Cockcroft-Gault formula
- 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.
- BMI < 18.5 Kg/m2.
- 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 IUDs.
- Concomitant use of Topiramate or other carbonic anhydrase inhibitors (e.g., Zonisamide, Acetazolamide or Dichlorphenamide)
- Concomitant use of GLP-1 medications (e.g. liraglutide, semaglutide, etc.).
- 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 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.
- Previous treatment for breast cancer including chemotherapy and endocrine therapy within the last 12 months.
- Women who will not have anyone available to assist them in case of need.
- Women who are planned to receive neoadjuvant therapy
- Triple negative BC.
- Patients with 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.