Stage 0 Breast CarcinomaPhase 1NCT02278965
Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer
A Phase 1 study testing Metformin and Omega-3 fatty acids in people with Stage 0 Breast Carcinoma and Breast Neoplasms, run by Katherine D. Crew at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Stage 0 Breast Carcinoma, Breast Neoplasms, Stage I Breast Carcinoma
- What is being tested?
- Metformin and Omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2015to 19 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Biomarker Modulation Study of Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer
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.
Read the detailed description
Metformin is a medication used to treat and prevent diabetes and omega-3 fatty acids has been shown to lower cholesterol and improve cardiovascular health. Research has shown that Metformin and omega-3 fatty acids may also be effective in preventing cancer. In this study, we want to find out what effects, good and/or bad, the Metformin and omega-3 fatty acids combination has on you and your risk of developing a new breast cancer.
- Conditions
- Stage 0 Breast Carcinoma, Breast Neoplasms, Stage I Breast Carcinoma, Stage II Breast Carcinoma, Stage III Breast Carcinoma
- Being tested
- Metformin, Omega-3 fatty acids
- Keywords
- Breast Cancer, Early Stage
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called N,N-dimethyl biguanide hydrochloride
Metformin 850mg, oral, twice a day for 12 months
Omega-3 fatty acidsDrug
Also called Docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA)
Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Main Arm | Experimental | Open Label- Metformin and Omega-3 fatty acids for 12 months post baseline data collection. Receives: Drug: Metformin; Drug: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months (approximately)
Secondary outcomes (18)
Percent in reduction of mammographic density
Determine the efficacy of these drug interventions in reducing mammographic density
Measured: baseline, 12 months
Change in fasting serum insulin microunits per milliliter
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
Measured: baseline, month 3, 6, 9, and 12
Change in C-peptide nanograms per milliliter
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
Measured: baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor 1 (IGF-1) nanograms per milliliter
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
Measured: baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor binding protein 1 (IGFBP-1) nanograms per milliliter
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
Measured: baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor binding protein 3 (IGFBP-3) milligrams per liter
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
Measured: baseline, month 3, 6, 9, and 12
Change in fasting serum glucose milligrams per deciliter
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
Measured: baseline, month 3, 6, 9, and 12
Change in total cholesterol milligrams per deciliter
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
Measured: baseline, month 3, 6, 9, and 12
Change in high-density lipoprotein (HDL) milligrams per deciliter
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
Measured: baseline, month 3, 6, 9, and 12
Change in low-density lipoprotein (LDL) milligrams per deciliter
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
Measured: baseline, month 3, 6, 9, and 12
Change in Leptin microunits per liter
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
Measured: baseline, month 3, 6, 9, and 12
Change in adiponectin micrograms per milliliter
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
Measured: baseline, month 3, 6, 9, and 12
Change in serum C-reactive protein milligrams per deciliter
Determine the efficacy of these drug interventions in modulating inflammatory markers.
Measured: baseline, month 3, 6, 9, and 12
Change in Interleukin-6 picograms per milliliter
Determine the efficacy of these drug interventions in modulating inflammatory markers.
Measured: baseline, month 3, 6, 9, and 12
Change in body mass index (BMI)
Determine the efficacy of these drug interventions in modulating anthropometric measures.
Measured: baseline, month 3, 6, 9, and 12
Change in systolic blood pressure
Determine the efficacy of these drug interventions in modulating anthropometric measures.
Measured: baseline, month 3, 6, 9, and 12
Change in diastolic blood pressure
Determine the efficacy of these drug interventions in modulating anthropometric measures.
Measured: baseline, month 3, 6, 9, and 12
Change in homeostatus model assessment (HOMA) score
Determine the efficacy of these drug interventions in modulating anthropometric measures.
Measured: baseline, month 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study start22 Jan 2015
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 0 Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katherine D. Crew
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katherine D. Crew, Columbia University
- Investigators
- Katherine Crew, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278965
- Sponsor's protocol ID
- AAAL2650
- Status last verified
- Aug 2022
- First submitted
- 28 Oct 2014
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Biomarker Modulation Study of Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02278965
- Acronym / sponsor ID
- AAAL2650
- Conditions
- Stage 0 Breast Carcinoma, Breast Neoplasms, Stage I Breast Carcinoma, Stage II Breast Carcinoma, Stage III Breast Carcinoma
- Keywords
- Breast Cancer, Early Stage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Katherine D. CrewUniversity, hospital or other
- Study start
- 22 Jan 2015 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Metformin is a medication used to treat and prevent diabetes and omega-3 fatty acids has been shown to lower cholesterol and improve cardiovascular health. Research has shown that Metformin and omega-3 fatty acids may also be effective in preventing cancer. In this study, we want to find out what effects, good and/or bad, the Metformin and omega-3 fatty acids combination has on you and your risk of developing a new breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Arm | Experimental | Drug: Metformin, Drug: Omega-3 fatty acidsOpen Label- Metformin and Omega-3 fatty acids for 12 months post baseline data collection. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: N,N-dimethyl biguanide hydrochlorideMetformin 850mg, oral, twice a day for 12 months | Drug | Main Arm |
| Omega-3 fatty acidsAlso: Docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA)Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months | Drug | Main Arm |
Primary outcome
Number of participants successfully completing the 1-year intervention
Time frame: 12 months (approximately)
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.
18 secondary outcomes
Percent in reduction of mammographic density
Time frame: baseline, 12 months
Change in fasting serum insulin microunits per milliliter
Time frame: baseline, month 3, 6, 9, and 12
Change in C-peptide nanograms per milliliter
Time frame: baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor 1 (IGF-1) nanograms per milliliter
Time frame: baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor binding protein 1 (IGFBP-1) nanograms per milliliter
Time frame: baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor binding protein 3 (IGFBP-3) milligrams per liter
Time frame: baseline, month 3, 6, 9, and 12
Change in fasting serum glucose milligrams per deciliter
Time frame: baseline, month 3, 6, 9, and 12
Change in total cholesterol milligrams per deciliter
Time frame: baseline, month 3, 6, 9, and 12
Change in high-density lipoprotein (HDL) milligrams per deciliter
Time frame: baseline, month 3, 6, 9, and 12
Change in low-density lipoprotein (LDL) milligrams per deciliter
Time frame: baseline, month 3, 6, 9, and 12
Change in Leptin microunits per liter
Time frame: baseline, month 3, 6, 9, and 12
Change in adiponectin micrograms per milliliter
Time frame: baseline, month 3, 6, 9, and 12
Change in serum C-reactive protein milligrams per deciliter
Time frame: baseline, month 3, 6, 9, and 12
Change in Interleukin-6 picograms per milliliter
Time frame: baseline, month 3, 6, 9, and 12
Change in body mass index (BMI)
Time frame: baseline, month 3, 6, 9, and 12
Change in systolic blood pressure
Time frame: baseline, month 3, 6, 9, and 12
Change in diastolic blood pressure
Time frame: baseline, month 3, 6, 9, and 12
Change in homeostatus model assessment (HOMA) score
Time frame: baseline, month 3, 6, 9, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Herbert Irving Comprehensive Cancer Center (HICCC) clinical trials pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Crew, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin and Omega-3 fatty acids in people with Stage 0 Breast Carcinoma and Breast Neoplasms, run by Katherine D. Crew at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants successfully completing the 1-year intervention (time frame: 12 months (approximately)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.