Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: acolbifene hydrochloride
Intervention description: Given orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 30 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase II trial is studying how well acolbifene works in preventing cancer in
      premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain
      drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or
      coming back.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group

          -  Premenopausal

          -  More than 6 months since initiating or discontinuing oral contraceptives

          -  At increased risk for breast cancer, as indicated by >= 1 of the following risk
             factors:

          -  BRCA1/2 mutation characterized as deleterious or of uncertain significance

          -  Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in
             situ

          -  Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia

          -  Family history consistent with hereditary breast cancer, as indicated by 1 of the
             following criteria:

               -  >= 4 relatives with breast cancer

               -  >= 2 relatives diagnosed with breast cancer at ≤ 50 years of age

               -  Breast and ovarian cancer diagnosed in same relative

          -  No suspicion for breast cancer on baseline mammogram performed between days 1-10 of
             menstrual cycle within 3 months prior to screening baseline RPFNA

          -  Exhibits hyperplasia with or without atypia (Masood score >= 14) with >= 500 cells AND
             Ki-67 positivity >= 2% by RPFNA performed within 6 months prior to initiation of study
             drug

          -  Estimated visual mammographic breast density category >= 5% on mammogram performed
             within 6 months prior to initiation of study drug

          -  Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen
             oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic
             profile and blood count within normal limits

          -  Absolute granulocyte count > 1,000/mm^3

          -  Platelets > 100,000/mm^3

          -  Hemoglobin > 10 g/dL

          -  Bilirubin < 2.0 mg/dL

          -  AST < 2 times upper limit of normal (ULN)

          -  Albumin > 3.0 g/dL

          -  Creatinine < 1.5 mg/dL

          -  Alkaline phosphatase < 2 times ULN

          -  Concurrent hormonal contraceptives allowed provided patient remains on the same
             hormonal regimen from 3 months prior to baseline aspiration until the completion of
             study treatment

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone
             health (1,200 mg calcium and 800 IU vitamin D daily)

          -  Negative pregnancy test prior to receiving study agent

        Exclusion Criteria

          -  pregnant or nursing

          -  nursing within the past 6 months

          -  Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)

          -  History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or
             hot flashes

          -  History of deep venous thrombosis

          -  History of allergic reactions attributed to compounds of similar chemical or
             biological composition to the study agent

          -  Other condition or concurrent illness that, in the opinion of the investigator, would
             make the patient a poor candidate for RPFNA

          -  Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole,
             exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen
             citrate, raloxifene, or arzoxifene hydrochloride)

          -  Other concurrent chemopreventive agents

          -  Concurrent anticoagulants

          -  Other concurrent investigational agents

          -  Bilateral breast implants