Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

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 1, early onset [BRCA1]/2 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
• Women who are premenopausal, are on a stable contraceptive regimen, and are planning to continue the same regimen through surgery are eligible to participate; for women who are on hormonal contraception regimens that have a placebo phase, the following should be recorded regarding the day of baseline core biopsy and the day of surgery: the agent, whether they are in active or placebo phase, the day of the phase (e.g. day 13 of 21-day active phase or day 4 of 7-day placebo phase); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
• Women who are using postmenopausal hormones, and are planning to continue the same regimen through surgery are eligible to participate; if the hormone therapy regimen is cyclical, the following should be recorded regarding the day of baseline core biopsy and day of surgery: the agent, the day of the phase (e.g. day 13 of 14-day estrogen phase etc); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
• Women with child-bearing potential who are not on hormonal contraception should be 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 or serum 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 gross skin invasion/ulceration 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 the breast
• A history of thromboembolic disorder or cerebral vascular disease
• Women who were using oral contraceptives or postmenopausal hormones within eight weeks prior to core needle biopsy, and then stopped following core needle biopsy, are not eligible; 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 (selective estrogen receptor modulators[SERMs]/selective progesterone receptor modulators [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