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NCT01381874 · ClinicalTrials.gov registry record · Phase 2
A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
A Phase 2 study of Postmenopausal and Metastatic ER+ Her2- Breast Cancer, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 297
- Enrollment target
- 20
- Study locations
NCT01381874 is a Phase 2 study of Postmenopausal and Metastatic ER+ Her2- Breast Cancer that has completed, run by Janssen Research & Development. The registered enrollment target is 297 participants, above the 108-participant average among 9 other Postmenopausal trials with a reported enrollment target (175% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT01381874, a Phase 2 study of Postmenopausal and Metastatic ER+ Her2- Breast Cancer, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 297 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Exemestane
- DRUG Abiraterone acetate + Prednisone/ Prednisolone + Exemestane
- DRUG Abiraterone acetate + Prednisone or Prednisolone
Study Locations (20)
California
- - Fresno
- - Los Angeles
- - Monterey
New York
- - East Syracuse
- - Johnson City
- - New York
Ohio
- - Cleveland
- - Columbus
- - Kettering
Alabama
- - Muscle Shoals
Illinois
- - Chicago
Maine
- - Waterville
Massachusetts
- - Boston
Michigan
- - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2011-08-24 |
| Est. Completion | 2018-08-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01381874
The ClinicalTrials.gov registry entry for NCT01381874 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 108-participant average among 9 other Postmenopausal trials with a reported enrollment target (175% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Postmenopausal appearing as the primary indexed condition, and to 3 interventions - of which Exemestane is the first listed.
NCT01381874 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT01381874 about?
NCT01381874 is a clinical study titled "A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy". 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 (...
What is the current status of trial NCT01381874?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 297 participants. The study started on 2011-08-24. Estimated completion is 2018-08-08.
What conditions does trial NCT01381874 study?
This clinical trial studies the following conditions: Postmenopausal, Metastatic ER+ Her2- Breast Cancer.
What interventions are being tested in trial NCT01381874?
The interventions under investigation include: Exemestane (DRUG), Abiraterone acetate + Prednisone/ Prednisolone + Exemestane (DRUG), Abiraterone acetate + Prednisone or Prednisolone (DRUG).
Who is sponsoring clinical trial NCT01381874?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01381874 being conducted?
This trial has 20 study locations across Alabama, California, Illinois, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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