Docosahexaenoic Acid in Preventing Recurrence in Breast Cancer Survivors

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01849250 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-474

 

This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Judy Garber, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Participants must have a history of histologically-confirmed breast cancer that meets the following criteria - Stage I, II, or III according to the American Joint Committee on Cancer (AJCC) (7th edition) - "Triple negative" disease defined here as invasive carcinoma that does not express the estrogen receptor (ER), progesterone receptor (PR) or human epidermal growth factor receptor 2 (HER2) as follows: - For ER and PR =< 10% by immunohistochemistry (IHC) AND no current or planned hormone therapy. - For HER2 any one of the following four options must apply - Criteria for defining HER2 negativity: - IHC: 0-1; fluorescence in situ hybridization (FISH) not performed; no adjuvant trastuzumab; patient eligible OR - IHC: 0-1; FISH =< 2.0 ; no adjuvant trastuzumab; patient eligible OR - IHC not performed; FISH =< 2.0 ; no adjuvant trastuzumab; patient eligible OR - IHC 2; FISH =< 2.0 ; no adjuvant trastuzumab; patient eligible - No evidence of disease at trial entry as determined by the investigator - >= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy and chemotherapy) - Participants must have a body mass index (BMI) >= 25, defined as (weight in kilograms/[height in meters]^2) - Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted - Daily DHA consumption =< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire - Mammogram within the last 6 months (normal/benign Breast Imaging-Reporting and Data System [bi-rads] 1 or 2) and no further routine breast imaging planned during the course of the study (6 months DHA/placebo) - Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%) - Absolute neutrophil count >= 1,500/uL - Platelets >= 75,000/uL - White blood cells >= 3,000/uL - Hemoglobin >= 10 g/dL - Total bilirubin within 1.5 times the institution's upper limit of normal (ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) within 1.5 times the institution's ULN - Serum creatinine within 1.5 times the institution's ULN - The effects of DHA on the developing human fetus at the recommended therapeutic dose are unknown; therefore, pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy - Willingness to comply with all study interventions and follow-up procedures including the ability to swallow the study drug - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months - A history of histologically-confirmed bilateral invasive breast cancer - Bilateral mastectomy - Prior history or evidence of metastatic breast cancer - Prior radiation therapy to the contralateral (unaffected) breast - Prior history of contralateral (unaffected) breast augmentation with breast implant placement - Known deleterious breast cancer (BRCA) 1/2 mutation carriers; of note BRCA mutation testing is not a requirement for study entry; women with BRCA mutations of unknown significance will be eligible - History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the month preceding study entry - History of chronic statin use, defined as any prescription in the preceding year - History of DHA supplementation > 200 mg/day in the month preceding study entry - History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators - History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year - Participants may not be receiving any other investigational agents during the study - Women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation - Women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening - Individuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participation - History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHA or corn/soy oil in placebo agent - Pregnant, breastfeeding, or women of childbearing potential unwilling to use a reliable contraceptive method
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