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治験 NCT06763328（対象：解剖学的ステージI乳がんAJCC v8、解剖学的ステージII乳がんAJCC v8、解剖学的ステージIII乳がんAJCC v8、侵襲性乳癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
シティ・オブ・ホープ医療センターMetformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
I. To determine if extended release metformin hydrochloride (metformin) can normalize glycosylated hemoglobin (HgbA1c) (< 5.7%) for women breast cancer survivors with HgbA1c between 5.7-6.4%.
EXPLORATORY OBJECTIVES:
I. To investigate whether metformin treatment of insulin resistance (versus standard of care alone) alters epigenetic changes (chromatin acetylation, chromatin opening, and methylation) and the level of inflammatory cytokines. (Pilot) II. To investigate whether normalization of HgbA1c alters epigenetic changes (chromatin acetylation, chromatin opening, and methylation) and the level of inflammatory cytokines. (Pilot)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care healthy diet and exercise handouts and extended release metformin orally (PO) once daily (QD) for 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
ARM II: Patients receive standard of care healthy diet and exercise handouts on study. Additionally, patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and in 12 months.
Metformin (Dimethylbiguanide) and Insulin Resistance in Women Completing Neoadjuvant and/or Adjuvant Cytotoxic Treatment of Stage I-III Breast Cancer
- 24363
- NCI-2024-10402 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- 24363 (その他の識別子) (City of Hope Medical Center)
- P30CA033572 (米国NIHの助成金/契約)
- U54CA285116 (米国NIHの助成金/契約)
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm I (standard of care, metformin) Patients receive standard of care healthy diet and exercise handouts and extended release metformin PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study. | 生体試料採取 Undergo blood sample collection 教育的介入 Receive standard of care healthy diet and exercise handouts Extended Release Metformin Hydrochloride Given PO アンケート管理 Ancillary studies |
実薬対照薬Arm II (standard of care) Patients receive standard of care healthy diet and exercise handouts on study. Additionally, patients undergo blood sample collection throughout the study. | 生体試料採取 Undergo blood sample collection 教育的介入 Receive standard of care healthy diet and exercise handouts アンケート管理 Ancillary studies |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Hemoglobin A1c (Hgb A1c) normalization | Will be defined as Hgb A1c \< 5.7%. Will be compared across groups (metformin + standard of care/usual medical care versus standard of care/usual medical care alone) using chi-square statistics. Data will be summarized using counts and percentages. | Up to 12 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
HgbA1c normalization | Will compare HgbA1c normalization as well as pairwise t-tests across treatment groups to examine the magnitude of change in HgbA1c. | At 3, 6, 12 and 24 months |
Documented informed consent of the participant and/or legally authorized representative
Agreement to allow lab draw of approximately 26 mL of blood (less than 3 tablespoons)
- To check blood counts, organ function and disease at baseline and 12 months
- Clinical labs at baseline, 3 months, 6 months,12 months, and 24 months
- Research labs at baseline, 6 months,12 months, and 24 months
Age: ≥ 18 years
Female sex assigned at birth
Ability to read and understand English or Spanish for questionnaires
Diagnosis of estrogen receptor (ER)-negative /HER2-wild type or -amplified invasive mammary carcinoma stages I-III
Receive systemic treatment for breast cancer treatment
Completed treatment for stage 1-3 breast cancer within 90 days to 5 years and are disease free
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
- Currently taking metformin or any other oral antidiabetic medications. Weight loss medications are permitted - e.g. semaglutide
- Taking tamoxifen or aromatase inhibitor
- Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin
- 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
- Previously diagnosed type 1 or type 2 diabetes
- Patients pregnant or within 1 year of pregnancy and completion of lactation (pregnancy tests are standard of care [SOC] for initiation of chemotherapy)
- 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
- 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
- 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
- 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)
シティ・オブ・ホープ医療センター344 件のアクティブな治験を探索アメリカ国立がん研究所3028 件のアクティブな治験を探索California