Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer (NCT00794989) | Clinical Trial Compass
TerminatedNot Applicable
Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer
Stopped: low accrual
United States20 participantsStarted 2008-04
Plain-language summary
RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer.
PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.
Who can participate
Age range21 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Patients enrolled in must meet ≥ 1 of the following criteria:
* History of unilateral or bilateral atypical ductal hyperplasia with or without family history
* History of atypical lobular hyperplasia or lobular carcinoma in situ with or without family history
* History of ductal carcinoma in situ
* Prior stage I breast cancer allowed provided it was adequately treated and therapy was completed ≥ 1 year ago
* Lifetime risk for developing breast cancer \> 20% (based on Gail or Claus model)
* No abnormal mammogram requiring short-term follow-up within the past 6 months
* No severe atypia or carcinoma cells on RPRNA
PATIENT CHARACTERISTICS:
* Premenopausal
* ECOG performance status 0-1
* Patients enrolled must meet the following criteria:
* No peri- or postmenopausal status as determined by estradiol levels \< 20 ng/dL and FSH levels \> 45 ng/dL
* No thrombocytopenia (defined as platelet count \< 50,000/mm\^3)
* Creatinine ≤ 1.5 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception consistently
* No other prior malignancy allowed except for the following:
* Basal cell or squamous cell carcinoma
* In situ cervical cancer
* No history of any of the following conditions within the past 5 years:
* Crohn disease
* Ulcerative colitis
* Inflammatory bowel disease
* Irritable bowel syndrome
* Celiac sprue
* Malabsorption syndrome
* Diverticulitis
* Diverticulosis
* No allergy to fl…
What they're measuring
1
Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months