Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy (NCT02314156) | Clinical Trial Compass
CompletedPhase 2
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
United States67 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Mean Levels of Telapristone Acetate in Breast Tissue
Timeframe: At the time of mastectomy, up to 5 weeks from baseline