NCT00930579 is a Phase 2 clinical trial of Metformin in Breast Cancer, sponsored by Columbia University.

Who is sponsoring NCT00930579?

NCT00930579 is sponsored by Columbia University.

What drugs are being tested in NCT00930579?

Interventions in NCT00930579: Metformin.

What condition does NCT00930579 study?

NCT00930579 studies Breast Cancer.

Is NCT00930579 still recruiting?

NCT00930579 is currently completed. Last updated 20 October 2022.

Are results published for NCT00930579?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-10-20 · How we verify

NCT00930579

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

Completed Phase 2 Results posted Last updated 20 October 2022

What this trial tests

Phase 2 trial testing Metformin in Breast Cancer in 35 participants. Completed in 9 January 2017.

Timeline

16 October 2009

Primary endpoint
10 May 2012

9 January 2017

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	16 October 2009
Primary completion	10 May 2012
Estimated completion	9 January 2017
Sites	1 location across United States

Drugs / interventions tested

Metformin (metformin) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Columbia University

Who can join

21 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tumor Proliferation in Tumor Specimens Primary · Baseline, up to 4 weeks

This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.

Premetformin Tumor Sample

Group	Value	95% CI
Metformin	2.17	± 1.60

Post Metformin Tumor Sample

Group	Value	95% CI
Metformin	2.165	± 1.67

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 4 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Metformin

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (19 terms — click to expand)

Reaction	System	Metformin
Diarrhea	Gastrointestinal disorders	—
Flatulence	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Anorexia	Metabolism and nutrition disorders	—
Fatigue	General disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Abdominal Distension	Gastrointestinal disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Taste Alteration	Nervous system disorders	—
Diarrhea	Gastrointestinal disorders	—
Dry Mouth	Investigations	—
Constipation	Gastrointestinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Diarrhea	Gastrointestinal disorders	—
Heartburn	Investigations	—
Vomiting	Gastrointestinal disorders	—
Back Pain	Musculoskeletal and connective tissue disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT00930579 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Repurposing metformin for cancer treatment: current clinical studies.
Chae YK, Arya A, Malecek MK, Shin DS, et al · · 2016 · cited 233× · PMID 27004404 · DOI 10.18632/oncotarget.8194
Drug repurposing for cancer therapy.
Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1
Repurposing metformin for the prevention of cancer and cancer recurrence.
Heckman-Stoddard BM, DeCensi A, Sahasrabuddhe VV, Ford LG. · · 2017 · cited 224× · PMID 28776080 · DOI 10.1007/s00125-017-4372-6
Targeted therapy for breast cancer prevention.
den Hollander P, Savage MI, Brown PH. · · 2013 · cited 91× · PMID 24069582 · DOI 10.3389/fonc.2013.00250
Metformin: an emerging new therapeutic option for targeting cancer stem cells and metastasis.
Rattan R, Ali Fehmi R, Munkarah A. · · 2012 · cited 89× · PMID 22701483 · DOI 10.1155/2012/928127
Presurgical trial of metformin in overweight and obese patients with newly diagnosed breast cancer.
Kalinsky K, Crew KD, Refice S, Xiao T, et al · · 2014 · cited 70× · PMID 24605899 · DOI 10.3109/07357907.2014.889706
Metformin: The Answer to Cancer in a Flower? Current Knowledge and Future Prospects of Metformin as an Anti-Cancer Agent in Breast Cancer.
Samuel SM, Varghese E, Kubatka P, Triggle CR, et al · · 2019 · cited 58× · PMID 31835318 · DOI 10.3390/biom9120846
Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Columbia University trials

Trials by the same sponsor.

NCT06558422 — Human Models of Selective Insulin Resistance: Pancreatic Clamp · Phase 1 · not yet recruiting
NCT07264582 — HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking · NA · not yet recruiting
NCT05992415 — Know Your Pressures NYC · NA · not yet recruiting
NCT05645211 — The AgRP and GH/IGF-1 Axis in Children · not yet recruiting
NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00930579 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 20 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00930579.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing