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
This is a randomized (study drug assigned by chance), open-label (all participants will know
the identity of the assigned study drug) study divided into three phases, screening,
treatment, and follow-up. During screening, potential patients will be assessed for study
eligibility after providing signed informed consent. The treatment phase will comprise a
series of 28-day cycles with continuous study treatment until breast cancer progression,
when an end-of-treatment visit will be completed before the follow-up phase begins. The
duration of participation in the study for an individual patient may be up to approximately
3.5 years, including follow-up evaluations. Patients will be evaluated for the safety and
effectiveness of study treatments. During the treatment phase, patients will take the
following study drugs by mouth once daily: abiraterone acetate, 1 g/day, as four 250-mg
tablets, on an empty stomach, and patients must not eat for at least 1 hour after
abiraterone acetate; prednisone (prednisolone when prednisone is not available), 5 mg/day;
and exemestane, 25 mg/day, as a single tablet. The treatment phase will consist of a series
of 28-day cycles with continuous study treatment until breast cancer progression. At the
planned interim analysis, the Data Review Committee has recommended that further
randomization to the abiraterone acetate alone group be stopped and that the study is to be
continued otherwise.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Up to approximately 1.5 years
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR018286
NCT01381874
August 2011
July 2014
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Fountain Valley, California 92708 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Scarborough, Maine 04074 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Las Vegas, Nevada 89109 | |
Sioux Falls, South Dakota | |
Bismarck, North Dakota 58501 |