Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
Condition: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ductal Breast Carcinoma In Situ; Lobular Breast Carcinoma In Situ; Stage 0 Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular
Intervention: Telapristone Acetate; Placebo; Telapristone Acetate; Placebo; Laboratory Biomarker Analysis; Questionnaire Administration
Intervention description: Given transdermally; Given PO; Given PO; Given transdermally; Correlative studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized trial studies transdermal or oral telapristone acetate in treating patients
      undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent
      breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally
      may be safer and have fewer side effects than oral administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy,
             pathology confirmed stage 0-II (including ductal carcinoma in situ), or prophylaxis
             (breast cancer, early onset [BRCA] mutation carriers, women with strong family history
             or lobular carcinoma in situ or other conditions where prophylactic mastectomy has
             been elected)

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

          -  Total bilirubin < 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) <
             2.5 x ULN

          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x
             ULN

          -  Creatinine < 2 x ULN

          -  Alkaline phosphatase < 2.5 x ULN

          -  Blood urea nitrogen < 2 x ULN

          -  Willing to use non-hormonal contraception (adequate barrier-type contraception or
             intrauterine device [IUD]) from the time the pregnancy test is performed for the
             duration of study participation, and 30 days after study drug cessation (for women of
             childbearing potential only)

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willing and able to schedule mastectomy 4 weeks (+/- 7days) following start of study
             agent

          -  Willing to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning
             beds) for the duration of study agent dosing

          -  Negative urine pregnancy test result, for participants of child bearing potential,
             within 5 days prior to first dose of study medication; female of child-bearing
             potential is any woman (regardless of sexual orientation, whether she has undergone a
             tubal ligation, or remains celibate by choice) who meets the following criteria: has
             not undergone a hysterectomy or bilateral oophorectomy; OR has had a menstrual period
             at any time in the preceding 12 consecutive months)

          -  Willing to use alcohol in moderation while taking study agent

        Exclusion Criteria:

          -  The presence of skin invasion by the breast cancer, or inflammatory changes with skin
             edema AND erythema. Note: Paget's disease is permitted.

          -  Women receiving a "nipple delay" procedure prior to mastectomy.

          -  Women with skin diseases (psoriasis, eczema) on breast.

          -  A history of thromboembolic disorder or cerebral vascular disease

          -  Use of oral contraceptives or other hormonal treatments within eight weeks prior to
             the randomization or during the period of the study; women should not have used
             Depo-Provera in the preceding 6 months; use of hormone coated IUD like Mirena is
             allowed

          -  Participants may not have received any other investigational agents in the previous 3
             months

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to telapristone (i.e. other progesterone antagonists)

          -  Taken tamoxifen or other selective estrogen/progesterone receptor modulators
             (SERMs/SPRMs) within two years prior to entering study or been required to discontinue
             SERM therapy due to thromboembolic or uterine toxicity

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  History of prior breast cancer-specific therapy within the previous 2 years; previous
             unilateral radiation in women scheduled for mastectomy of the contralateral side is
             allowed

          -  Pregnant or breastfeeding

          -  Currently taking spironolactone

          -  Recent history (within 6 months) of alcoholism or drug abuse

          -  Known active infection with human immunodeficiency virus (HIV), hepatitis A, B, or C