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Clinical Trial NCI 2013-01-03

Title
Intra-mammary distribution of transdermal telapristone versus oral telapristone: a randomized window trial in women undergoing mastectomy
Principal Investigator
Seema Khan
Details
  • Status: Accepting New Patients
  • Study Type: Prevention, Treatment
  • Protocol No:.NCI 2013-01-03
Purpose
The purpose of this study is to see if we can treat the breast with drugs applied to the skin of the breast rather than pills taken by mouth.
Overview
By developing methods to treat the breast with a gel applied to the skin, we hope to greatly reduce the drug dose to the rest of the body, and therefore decrease side-effects of drugs taken for prevention of breast cancer. In this study, we will compare the amount of the drug that reaches different parts of the breast when it is taken as a pill (the usual way), or applied as gel to the breast skin (the new way). The drug is called telapristone. The use of telapristone (the study drug) in this study is investigational, meaning that it is not approved by the Food and Drug Administration (FDA). Telapristone is currently being examined in clinical trials for uterine fibroids and endometriosis. It is a selective progesterone receptor modulator; in other words, it works against the hormone, progesterone, which is thought to play a role in breast cancer development.
Eligibility
Some of the eligibility criteria include:
  • Participants must be women, schedule for mastectomy for breast cancer therapy.
  • Participants must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
This study has two study groups. Group 1 will receive telapristone by mouth and placebo gel to apply to each breast. Group 2 will receive telapristone gel applied to each breast and placebo capsule by mouth. Participants will receive the study medication for approximately 4 weeks.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 19-Oct-17 07:37 AM

 

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