Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer
Condition: Breast Atypical Ductal Hyperplasia; Breast Atypical Lobular Hyperplasia; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ; Invasive Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Breast Carcinoma In Situ; Carcinoma, Ductal, Breast; Hyperplasia
Intervention: Bexarotene; Questionnaire Administration
Intervention description: Given topically; Ancillary studies
Intervention MeSH terms: Bexarotene
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase I trial studies the side effects and best dose of bexarotene in preventing breast
      cancer in patients at high risk for breast cancer. Bexarotene belongs to a class of drugs
      that are called rexinoids, and it may reduce the incidence of breast tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be at high risk as defined by a history of breast cancer (invasive
             or ductal breast carcinoma in situ [DCIS]) and be at least 5 years out from diagnosis,
             or lobular carcinoma in situ (LCIS), or proliferative benign breast disease such
             atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or genetic test
             confirmation of BRCA 1/2 mutation carrier or have a breast cancer risk assessment >=
             1.7% in 5 years or a lifetime risk >= 20%

          -  No evidence of disease (in situ or invasive cancer that would normally be treated by
             resection) at trial entry as determined by the investigator; diagnosis of invasive
             cancer must be at least 5 years prior to initiation on trial

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

          -  Leukocytes >= 3,000/microliter

          -  Absolute neutrophil count >= 1,500/microliter

          -  Platelets >= 100,000/microliter

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 1.5 x institutional upper limit of normal (ULN)

          -  Creatinine =< 1.5 x institutional ULN

          -  Hemoglobin >= 10 g/dL

          -  Thyroid-stimulating hormone (TSH) within normal institutional limits

          -  Triglycerides =< 300 mg/dl

          -  Total cholesterol =< 300 mg/dl

          -  >= 6 months from all previous breast cancer treatment (including endocrine therapy)

          -  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 benign core biopsy of this breast will be permitted

          -  Participants need to have had any breast imaging with a normal/benign (bi-rads 1 or 2)
             result within 180 days of day 0 and no further routine breast imaging planned during
             the course of the study (4 weeks); exception: if the mammogram result was a bi-rads 0
             and the imaging work-up (ultrasound and/or magnetic resonance imaging [MRI]) result
             comes back normal/benign (bi-rads 1 or 2) before treatment initiation, then
             participant is eligible.

          -  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; in
             women of childbearing potential, effective contraception must be used for one month
             prior to the initiation of therapy, during therapy, and for at least one month
             following discontinuation of therapy; it is recommended that two reliable forms of
             contraception be used simultaneously; if participants are interested in enrolling and
             have not met the requirement for contraception, they will be seen in the clinic in 1
             month for re-evaluation once they have met this requirement and ensure all other
             eligibility criteria is met prior to dose assignment

          -  Willingness to comply with all study interventions and follow-up procedures including
             the ability to apply the study drug to the breast

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Ability to avoid exposure of the treated breast area to sunlight and artificial
             ultraviolet light during the use of bexarotene gel

        Exclusion Criteria:

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to bexarotene gel, oral or topical retinoids

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, thromboembolic disease, or psychiatric illness/social situations that
             would limit compliance with study requirements

          -  Pregnant, or had given birth, or nursed at any time during the last 12 months

          -  Women with a history of any cancer within the last 3 years, except for non-melanoma
             skin cancer; history of breast cancer must be at least > 5 years from diagnosis

          -  Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast
             augmentation surgery including breast implants or breast reductions) or combination of
             breast radiation and surgery involving both breasts

          -  Prior history or evidence of metastatic breast cancer

          -  Prior history of histologically confirmed bilateral invasive breast cancer

          -  Current use or < 6 months since use of selective estrogen receptor modulator (SERMS)
             or aromatase inhibitors or any other investigational treatment for breast cancer
             prevention or therapy

          -  Skin lesions that disrupt the stratum corneum (e.g., eczema, ulceration) or any
             breakdown of the skin

          -  Current use of a retinol containing agent or any retinoid analogue drug within the
             last 30 days

          -  Dietary vitamin A intake >= 5,000 IU/day (as determined by dietary supplementation)

          -  Treatment with any investigational drug or investigational biologic within 30 days of
             initiating study treatment or during the study

          -  History of human immunodeficiency virus (HIV) or active hepatitis C