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Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy




Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy (USON 10302)

Study Description:

The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

Inclusion Criteria:

» Female patients must be postmenopausal
» ER+, Human epidermal growth factor receptor 2 (Her2) negative metastatic breast cancer
» Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression
» No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy
» Eastern Cooperative Oncology Group (ECOG) performance status score of one or less

Exclusion Criteria:

» Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor
» Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization
» Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
» Clinical or biochemical evidence of hyperaldosteronism or hypopituitarism
» Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments

Location:


Texas Oncology - Baylor Charles A. Sammons Cancer Center
3410 Worth Street
Dallas , TX 75246

Lead Principal Investigator:

O'Shaughnessy, Joyce, MD



For further information regarding this study, please contact the Office of Clinical Oncology Research Coordination at 214-818-8472 or via email at cancer.trials@baylorhealth.edu.

Last Update: September 27, 2011
† Baylor Research Institute and Texas Oncology are not affiliated. Each reviews, approves, and conducts clinical trials independently. Their clinical trials are listed together on this website for the convenience of patients.