Clinical Trial NU 12B09
- Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women with Stage 0-II Primary Breast Cancer: PACT-B (Progesterone Antagonists for Cancer Treatment for Breast) Study
- Principal Investigator
- Seema Khan
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 12B09
- The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared to a placebo.
- CDB-4124 (also called Proellex) is a medication that works against the hormone, progesterone. It belongs to a group of drugs called “selective progesterone receptor modulators”. Although it is not known whether CDB-4124 will be effective against breast cancer, the research team responsible for this study thinks it is a very promising drug to test, since it blocks progesterone, a hormone which may help breast tumors to grow. CDB4124 is not approved by the Food and Drug Administration (FDA) for breast cancer treatment, therefore its use in this study is investigational. It is currently being examined in clinical trials for a variety of conditions including uterine fibroids and endometriosis. The researchers in this study would like to compare changes in breast cancer cells of women who have taken CDB-4124 prior to surgery to those from women who have taken a placebo pill prior to surgery.
Some of the eligibility criteria include:
- Participants must be women with invasive breast cancer stages I-III.
- Participants must be 18 or older.
- Description of Treatment
- Participants in this study will take one pill by mouth each day for a minimum of 2 weeks and maximum of 10 weeks depending on when surgery is planned.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
- A Pilot Study of Time Restricted Diet in Obese/Overweight Pre & Postmenopausal Women
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last updated: 20-Dec-14 02:50 PM
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