Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

NCT02278965 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AAAL2650
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether it is feasible to give a combination of Metformin and omega-3 fatty acids for one year to women with a history of early stage breast cancer. We will also evaluate whether the metformin and omega-3 fatty acids combination causes changes in breast tissue, blood, and mammograms.

Conditions

Stage 0 Breast Carcinoma; Breast Neoplasms; Stage I Breast Carcinoma; Stage II Breast Carcinoma; Stage III Breast Carcinoma

Keywords

Breast Cancer; Early Stage

Outcome Measures

Primary Outcomes (1)

• Number of participants successfully completing the 1-year intervention

  The primary objective is to assess the safety and feasibility of a one-year intervention of metformin and omega-3 fatty acids in early stage breast cancer patients who completed adjuvant treatment.

  12 months (approximately)

Secondary Outcomes (18)

• Percent in reduction of mammographic density

  baseline, 12 months

• Change in fasting serum insulin microunits per milliliter

  baseline, month 3, 6, 9, and 12

• Change in C-peptide nanograms per milliliter

  baseline, month 3, 6, 9, and 12

• Change in insulin-like growth factor 1 (IGF-1) nanograms per milliliter

  baseline, month 3, 6, 9, and 12

• Change in insulin-like growth factor binding protein 1 (IGFBP-1) nanograms per milliliter

  baseline, month 3, 6, 9, and 12

Study Arms (1)

Main Arm

EXPERIMENTAL

Open Label- Metformin and Omega-3 fatty acids for 12 months post baseline data collection.

Drug: Metformin; Drug: Omega-3 fatty acids

Interventions

Metformin DRUG

Metformin 850mg, oral, twice a day for 12 months

Also known as: N,N-dimethyl biguanide hydrochloride

Main Arm

Omega-3 fatty acids DRUG

Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months

Also known as: Docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA)

Main Arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically-confirmed stage 0, I, II, or III breast carcinoma without evidence of disease at trial entry. Participants with a resected local recurrence are eligible
• Minimum of 6 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery and no evidence of recurrent disease
• Minimum of 6 months since completion of adjuvant tamoxifen (tamoxifen is known to lower mammographic density119-121). Current use of a third generation aromatase inhibitor \[AI\] (i.e., anastrozole, letrozole, exemestane) is permitted provided that the participant has been on a stable dose for the past 6 months
• Age 21 to 75 years. Both pre- and postmenopausal women will be included in this study. We will exclude perimenopausal women, defined as menstrual cycle irregularity (variable cycle length that differs from normal by more than 7 days) and an Follicle-Stimulating Hormone (FSH) greater than 20 mili international units
• Negative serum pregnancy testing
• Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy
• Eastern Cooperative Oncology Group (ECOG) performance status less than 2
• Participants must have normal organ and marrow function within 28 days prior to randomization
• Body mass index (BMI) greater than or equal to 25 kilograms per meter squared or baseline fasting glucose of less than 126 milligrams per deciliter
• Participants must have a baseline mammographic density greater than or equal to 25 percent based upon the Breast Imaging Reporting and Data System (BIRADS) density score of 2, 3, or 4. Women with a baseline mammographic density of less than 25 percent (BIRADS Score= 1) will not be eligible
• Willingness to abstain from all omega-3 fish oil supplements for 30 days prior to baseline evaluation and during the study intervention
• Willingness to comply with all study interventions and follow-up procedures
• Ability to understand and willingness to sign a written informed consent document

You may not qualify if:

• History of histologically-confirmed bilateral breast cancer
• History of or plans for bilateral mastectomies
• Evidence of metastatic breast cancer
• Prior radiation therapy or implant in the contralateral breast
• Known diabetes (type 1 or 2) or baseline fasting glucose greater than 126 milligrams per deciliter
• Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association \[NYHA\] Class III or IV functional status, history of acidosis of any type, intake of 3 or more alcoholic beverages per day on average over the past 6 months)
• Currently taking metformin, sulfonylureas, thiazolidinediones, or insulin for any reason
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or omega-3 fatty acids
• Receiving hormone replacement therapy, tamoxifen, or raloxifene within 6 months of trial entry
• Participants may not be receiving any other investigational agents for 30 days prior to baseline evaluation and during the study intervention
• Any omega-3 fatty acids should not be taken for 30 days prior to baseline evaluation and during the study intervention. If participants are consuming any of these items and would like to participate in this study, then a 30-day washout period will be required. - Uncontrolled or significant co-morbid illness patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Katherine D. Crew: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Links

• Herbert Irving Comprehensive Cancer Center (HICCC) clinical trials page

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Metformin; Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Katherine Crew, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: January 22, 2015
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

US (1)