A Phase 2 interventional study of Metformin in Breast Cancer, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.
Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States. Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Exclusion Criteria:
Women with newly diagnosed early invasive breast cancer will receive Metformin
Drug: Metformin
1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery
Also known as: Metformin hydrochloride
Tumor Proliferation in Tumor Specimens
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.
Time frame: Baseline, up to 4 weeks
The investigator conducted an open-label, single-arm, presurgical trial with metformin at Columbia University Medical Center (CUMC) in New York, New York. Between October 2009 and August 2011.
| Milestone | Metformin |
|---|---|
| Started | 35 |
| Completed | 33 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Discontinued due to rescheduled surgery | 1 |
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.
| percentage of ki-67 positive cells | Metformin |
|---|---|
| Premetformin Tumor Sample | 2.17 ± 1.60 |
| Post Metformin Tumor Sample | 2.165 ± 1.67 |
Collected over Up to 4 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin | 0/33 (0%) | 0/33 (0%) | 29/33 (87.9%) |
| Event | Metformin |
|---|---|
| DiarrheaGastrointestinal disorders | 21/33 |
| FlatulenceGastrointestinal disorders | 15/33 |
| NauseaGastrointestinal disorders | 11/33 |
| AnorexiaMetabolism and nutrition disorders | 10/33 |
| FatigueGeneral disorders | 10/33 |
| DizzinessNervous system disorders | 8/33 |
| HeadacheNervous system disorders | 8/33 |
| Abdominal DistensionGastrointestinal disorders | 7/33 |
| Abdominal PainGastrointestinal disorders | 7/33 |
| Taste AlterationNervous system disorders | 6/33 |
Of the 35 patients enrolled, 33 completed the trial and were considered evaluable. Patients were evaluable if they had sufficient pre and post treatment tumor tissue for analysis, and demonstrated at least 75% compliance with metformin, as measured by weekly telephone interviews and pill counts.
| Age, Continuous(years) | Metformin |
|---|---|
| Mean | 56.3 ± 11 |
| Sex: Female, Male(Participants) | Metformin |
|---|---|
| Female | 33 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Metformin |
|---|---|
| Hispanic | 28 |
| Non-Hispanic White | 2 |
| Non-Hispanic Black | 2 |
| Asian | 1 |
| Region of Enrollment(participants) | Metformin |
|---|---|
| United States | 33 |
Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin