Protocol
12-140
Full Title
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
Purpose
Letrozole and anastrozole — drugs that block estrogen production — are used to treat metastatic breast cancer in postmenopausal women whose tumors contain estrogen receptors (ER). However, these drugs often stop working. Exemestane also lowers estrogen production and is used to treat postmenopausal women with early-stage ER-positive breast cancer. It has also been shown to be effective in women with metastatic breast cancer.
The purpose of this study is to see if giving exemestane with a drug called abiraterone is more effective than either drug alone in postmenopausal women with metastatic ER-positive breast cancer that has continued to grow despite letrozole or anastrozole treatment. Abiraterone lowers estrogen production in a way that is different than letrozole, anastrozole, or exemestane. Abiraterone is approved for treating advanced prostate cancer, but its use for treating breast cancer is considered investigational. It is given with prednisone.
In this study, women will be randomly assigned to receive one of three treatment regimens: abiraterone, prednisone, and exemestane; abiraterone and prednisone; or exemestane alone.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be postmenopausal women with metastatic ER-positive breast cancer that has continued to grow despite letrozole or anastrozole therapy.
- Patients may have had up to two prior regimens of treatment for metastatic disease (but not more than one regimen of chemotherapy).
- At least 2 weeks must have passed since the last dose of letrozole, anastrozole, chemotherapy, or radiation therapy and entry into the study.
- Patients may not have had prior exemestane therapy.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is open to patients age 18 and older.
Disease(s)
Breast Cancer
Locations
ClinicalTrials.gov
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