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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: Completed Phase 2 study of Postmenopausal and Metastatic ER+ Her2- Breast Cancer, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such a
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 |
What the finished NCT01381874 record still lists
NCT01381874 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 9 other Postmenopausal trials with a reported enrollment target (175% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Postmenopausal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01381874's enrollment target sits among peer trials
297 2nd of 9 the highest of 9 other Postmenopausal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postmenopausal trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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