Clinical Trial DRUG MDV3100-12
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal
- Principal Investigator
- William Gradishar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG MDV3100-12
- The study will help doctors determine if treatment with drugs called enzalutamide and exemestane taken together is better at slowing the growth of breast cancer than treatment with exemestane alone. This study is also being done to test whether these 2 drugs can be given together safely to women with your type of breast cancer.
- Exemestane is a drug that is approved as a treatment for certain types of breast cancer by the United States Food and Drug Administration (FDA). It is given to patients with hormone positive breast cancer to decrease the production of female hormones called estrogens. This type of breast cancer requires estrogen to grow. Exemestane works by blocking an enzyme called “aromatase,” that converts male hormones (androgens) into estrogens. Enzalutamide is a drug that is approved by the FDA for the treatment of men with advanced prostate cancer whose disease has progressed on androgen deprivation therapy and who have previously received docetaxel therapy. Enzalutamide in this study is considered experimental since it is not approved by the FDA for treatment of breast cancer. Enzalutamide works by blocking the action of androgens. Most women with hormone receptor positive breast cancer (about 7 out of 10) also have androgen receptor positive breast cancer; in other words, the same breast cancer cell can express both hormone and androgen receptors. There is reason to believe that enzalutamide may limit androgen receptor activity resulting from the increase in androgens from exemestane treatment. While the role of androgen receptor is unknown in breast cancer biology and is the subject of this study, there is scientific rationale to investigate whether enzalutamide added to exemestane may possibly slow or stop breast tumor growth.
Some of the eligibility criteria include:
- Participants in this study must be postmenopausal women with advanced breast cancer that is hormone receptor-positive and HER2-normal.
- Participants must have disease that cannot be cured by surgery or radiotherapy.
- Participants must be 18 or older.
- Description of Treatment
- Participants in this study will be randomly assigned to receive either enzalutamide and exemestane or placebo and exemestane. These are taken by mouth every day. Participants who get worse during this part of the study will be eligible to continue on to open label treatment if they were taking placebo. Participants who are eligible for open label treatment will begin taking enzalutamide along with continuing to take exemestane.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes,Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
last updated: 05-May-15 02:12 AM
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