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Breast CancerPhase 2NCT01252277

Breast Cancer Risk Biomarkers in Premenopausal Women

A Phase 2 study testing Lovaza™ in people with Breast Cancer, run by Carol Fabian, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer. This drug is currently approved by the FDA for reducing blood levels of triglycerides. Read more about this study

Who is it for?
Ages 25 to 54 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Lovaza™
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Nov 2010to Apr 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 25 to 54 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must be premenopausal and between the ages of 25 and 54 and must have had a menstrual period within the past 12 months. Women who are not menstruating regularly due to use of certain types of contraceptives may be entered with restrictions. Their estrogen progesterone, and follicle stimulating hormone (FSH) levels must be documented at baseline random periareolar fine needle aspiration (RPFNA) and their off study RPFNA must take place at a similar portion of their cycle (high or low progesterone levels). In order to do this a serum progesterone will have to be obtained ~ 4 weeks before planned RPFNA and again 2 weeks later such that the RPFNA can be performed in the same phase of the "cycle" as baseline.
  • Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:
  • A five-year Gail risk of ≥ 1.67% or three times the average risk for a woman of the same age using either the Surveillance Epidemiology and End Results (SEER, http://seer.cancer.gov) database or the NCI Breast Cancer Risk Assessment Tool (www.cancer.gov/bcrisktool)., or 10 yr Tyrer-Cuzick risk twice that of the population risk as listed in model, or RPFNA atypia
  • BMI <40 Kg/m3
  • A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer.
  • Multiple prior biopsies or at least one prior biopsy exhibiting atypical hyperplasia (AH), lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS).
Show all 21Show fewer
  • RPFNA evidence of hyperplasia with atypia within the last three years;
  • Chest or neck radiation before age 30;
  • Mammographic breast density by visual estimate equals or exceeds 50%.
  • Subjects must be willing to continue the same hormonal milieu present at baseline throughout trial. If not using an oral, vaginal, or topical contraceptive, must be willing to actively use barrier methods of contraception to prevent pregnancy.
  • Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial), ingestion of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker assessment.
  • Subjects must be willing to undergo measurement of height, weight, and BMI and undergo body composite analysis (DEXA) at initiation and conclusion of intervention.
  • Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and are either not eligible or are not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contralateral (uninvolved breast) will be studied by RPFNA. The subject may not have had any radiation therapy to the contralateral breast to be studied
  • Subjects > 40 must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Subjects of sufficient age and/or risk for a baseline mammogram must be willing to have an off-study mammogram performed 6 months after study entry.
  • Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at ~6.5 months after starting Lovaza™.
  • Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score 14 or higher). There must be ≥500 epithelial cells on the slide for cytomorphology and evidence of proliferation by Ki-67 staining. There must be sufficient reserved methanol- formalin-fixed material for real time quantitative polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.
  • Subjects must be willing to undergo phlebotomy at baseline, and 6 months and 6.5 months approximately 3 tablespoons of blood will be obtained at baseline, and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .
  • Subjects must produce a spot urine sample at baseline, 6 months and at study conclusion. Baseline urine sample will in part be used to document that subject is not pregnant.
  • Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life, relevant family history, personal health and reproductive history and medications at initiation and conclusion of the intervention.
  • Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA
  • -This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast.

Who cannot join

  • Women that have had a metastatic malignancy of any kind.
  • Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.
  • Women who are currently taking anticoagulants.
  • Women who have breast implants.
  • Women who have undergone change in their hormonal milieu in the past 6 months this includes pregnancy, lactation, or stopping or starting hormonal contraceptives..
  • Women who have taken omega 3 fatty acid supplements within 3 weeks prior to their baseline RPFNA.
  • Women who regularly take NSAIDS (>7 tablets weekly).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: Modulation of Breast Cancer Risk Biomarkers in Premenopausal Women by High Dose Omega-3 Fatty Acids

This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer. This drug is currently approved by the FDA for reducing blood levels of triglycerides.

Read the detailed description

The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid esters [eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg] daily in the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice daily) will have a favorable side effect profile and potential efficacy as demonstrated by favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer in premenopausal women.

Conditions
Breast Cancer
Being tested
Lovaza™
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lovaza™Drug

    Also called esters of EPA and DHA

    4 capsules daily for 6 months

Study groups in NCT01252277
Study groupRoleWhat they receive
Lovaza™ExperimentalLovaza™ (two 1 gram capsules twice daily) for six months
Receives: Drug: Lovaza™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day

    The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.

    Measured: 6 month visit

Secondary outcomes (4)

  1. Modulation of the Risk Biomarker Masood Score

    Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.

    Measured: 6 month value compared to baseline value

  2. Modulation of Ki-67 Expression

    Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67

    Measured: 6 month value compared to baseline value

  3. Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.

    Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.

    Measured: baseline to end of intervention (~6 months)

  4. Change in Quality of Life.

    Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.

    Measured: duration of intervention, baseline to ~ 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252277
Sponsor's protocol ID
12349
Status last verified
Jun 2016
First submitted
23 Nov 2010
Last updated
21 Jul 2016
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lovaza™ in people with Breast Cancer, run by Carol Fabian, MD 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 21 inclusion and 7 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 21 Jul 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day (time frame: 6 month visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252277.

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 21 Jul 2016.

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