NCT00930579

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2012

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2017

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

2.6 years

First QC Date

June 29, 2009

Results QC Date

June 15, 2017

Last Update Submit

October 14, 2022

Conditions

Breast Cancer

Keywords

Breast CancerMetformin

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, up to 4 weeks

Study Arms (1)

Metformin

EXPERIMENTAL

Women with newly diagnosed early invasive breast cancer will receive Metformin

Drug: Metformin

Interventions

MetforminDRUG

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
Metformin

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
  • Body mass index \> 25
  • Age ≥ 21 years
  • No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
  • Signed informed consent

You may not qualify if:

  • History of diabetes mellitus requiring medical therapy
  • Treatment with other investigational drugs within 6 months of study entry
  • Significant renal impairment with a creatinine \> 1.4 mg/dl
  • Other serious intercurrent medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • Kalinsky K, Zheng T, Hibshoosh H, Du X, Mundi P, Yang J, Refice S, Feldman SM, Taback B, Connolly E, Crew KD, Maurer MA, Hershman DL. Proteomic modulation in breast tumors after metformin exposure: results from a "window of opportunity" trial. Clin Transl Oncol. 2017 Feb;19(2):180-188. doi: 10.1007/s12094-016-1521-1. Epub 2016 Jun 15.

    PMID: 27305912DERIVED

  • Kalinsky K, Crew KD, Refice S, Xiao T, Wang A, Feldman SM, Taback B, Ahmad A, Cremers S, Hibshoosh H, Maurer M, Hershman DL. Presurgical trial of metformin in overweight and obese patients with newly diagnosed breast cancer. Cancer Invest. 2014 May;32(4):150-7. doi: 10.3109/07357907.2014.889706. Epub 2014 Mar 7.

    PMID: 24605899DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Dawn Hershman, MD
Organization
Columbia University
dlh23@cumc.columbia.edu
212-305-1945

Study Officials

  • Dawn L Hershman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine & Epidemiology

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

October 16, 2009

Primary Completion

May 10, 2012

Study Completion

January 9, 2017

Last Updated

October 20, 2022

Results First Posted

October 20, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)