Clinical Trial DRUG MDV3100-11
- A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative Breast Cancer
- Principal Investigator
- William Gradishar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG MDV3100-11
- The study will help doctors decide if enzalutamide may be a potential treatment for women with breast cancer, including triple-negative breast cancer, which expresses the androgen receptor. This study is also being done to test the safety and tolerability of enzalutamide, meaning, how taking enzalutamide may affect a patient's health or make her feel.
- Enzalutamide is known as an androgen receptor inhibitor, which means that it blocks activity of the hormone testosterone. In breast cancer, inhibiting the androgen receptor may possibly slow or stop tumor growth. This is the second study using enzalutamide in the treatment of women with breast cancer.
Some of the eligibility criteria include:
- Participants must be women at least 18 years of age.
- Participants must have advanced androgen receptor-positive, triple-negative breast cancer.
- Description of Treatment
- Study participants will take enzalutamide once per day by mouth during the treatment period, which starts on study Day 1. The treatment period will end when the doctor decides that the participant should stop taking enzalutamide, the participants start a new cancer therapy or clinical trial, or if the participant wants to stop taking enzalutamide.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 2, Randomized, Open-Label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients with FGF Aberrant Metastatic Breast Cancer
- An Open-Label, Phase II, Single-Arm Study of Everolimus in Combination with Letrozole in the Treatment of Postmenopausal Women with Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer
- A Phase III Trial to Compare the safety and efficacy of Lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first or second line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies
- A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
- 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
- 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: 22-Oct-14 11:28 PM
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