Clinical trial NCT00930579: Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation
Official title: Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Metformin
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2009-06-30
Enrollment: 35
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Tumor Proliferation in Tumor Specimens
timeFrame: Baseline, up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn L Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.