Breast Cancer Risk Biomarkers in Premenopausal Women

NCT01252277 | Completed Phase 2 Results

• 1 other identifier: 12349
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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.

  6 month visit

Secondary Outcomes (4)

• Modulation of the Risk Biomarker Masood Score

  6 month value compared to baseline value

• Modulation of Ki-67 Expression

  6 month value compared to baseline value

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

  baseline to end of intervention (~6 months)

• Change in Quality of Life.

  duration of intervention, baseline to ~ 6 months

Study Arms (1)

Lovaza™

EXPERIMENTAL

Lovaza™ (two 1 gram capsules twice daily) for six months

Drug: Lovaza™

Interventions

Lovaza™ DRUG

4 capsules daily for 6 months

Also known as: esters of EPA and DHA

Lovaza™

Eligibility Criteria

• Age: 25 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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™.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Carol Fabian, MD: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Omacor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Carol J. Fabian, M.D.
• Organization: University of Kansas Medical Center

cfabian@kumc.edu

913-588-7791

Study Officials

• Carol Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Breast Cancer Prevention Unit

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: December 2, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 21, 2016
• Results First Posted: July 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)