Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

This is an interventional prevention trial for BRCA1 Mutation Carrier Read More

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
• Willing to refrain from using soy supplements, over the counter estrogen supplements like estroven, Chinese herbs, or other over-the-counter (OTC) herbal products

Exclusion Criteria:

• The presence of skin invasion by the breast cancer, or inflammatory changes with skin edema AND erythema
• Women with skin diseases (psoriasis, eczema)
• 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