RECRUITING

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

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Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Invasive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial evaluates how often women develop insulin resistance and type-2 diabetes and compares metformin with usual care to usual care alone in treating insulin resistance in women with stage I-III breast cancer after chemotherapy. Insulin resistance occurs when cells stop responding to insulin and is a risk factor for developing diabetes and heart disease. Higher levels of insulin have been shown to be associated with aggressive breast cancer. Metformin hydrochloride decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. Metformin as well as standard of care diet and exercise education is known to lower blood sugar. However, chemotherapy may accelerate metabolic disorders, such as high blood sugar, and the impact of metformin in these breast cancer survivors is not known. Giving metformin with usual care may be more effective than usual care alone in preventing or reversing insulin resistance in women with stage I-III breast cancer after chemotherapy.

Official Title

Metformin (Dimethylbiguanide) and Insulin Resistance in Women Completing Neoadjuvant and/or Adjuvant Cytotoxic Treatment of Stage I-III Breast Cancer

Quick Facts

Study Start:2024-12-16
Study Completion:2029-06-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06763328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Agreement to allow lab draw of approximately 26 mL of blood (less than 3 tablespoons)
  3. * To check blood counts, organ function and disease at baseline and 12 months
  4. * Clinical labs at baseline, 3 months, 6 months,12 months, and 24 months
  5. * Research labs at baseline, 6 months,12 months, and 24 months
  6. * Age: ≥ 18 years
  7. * Female sex assigned at birth
  8. * Ability to read and understand English or Spanish for questionnaires
  9. * Diagnosis of estrogen receptor (ER)-negative /HER2-wild type or -amplified invasive mammary carcinoma stages I-III
  10. * Receive systemic treatment for breast cancer treatment
  11. * Completed treatment for stage 1-3 breast cancer within 30 days to 3 years and are disease free
  12. * Women who receive drugs for weight loss - e.g. semaglutide - prior to diagnosis are eligible for this protocol and can continue the drug during the intervention
  1. * Currently taking metformin or any other oral antidiabetic medications. Weight loss medications are permitted - e.g. semaglutide
  2. * Taking tamoxifen or aromatase inhibitor
  3. * Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin
  4. * Participants with acute or chronic renal insufficiency (a glomerular filtration rate \[GFR\] \< 30 mL/min/1.73m\^2) or those with acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period
  5. * Previously diagnosed type 1 or type 2 diabetes
  6. * Patients pregnant or within 1 year of pregnancy and completion of lactation (pregnancy tests are standard of care \[SOC\] for initiation of chemotherapy)
  7. * Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  8. * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  9. * An employee who is under the direct/indirect supervision of the principal investigator (PI)/a co-investigator/the study manager and/or a direct study team member
  10. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Victoria L Seewaldt
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
University of California-Riverside
Riverside, California, 92521
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Victoria L Seewaldt, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2029-06-16

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2029-06-16

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Invasive Breast Carcinoma