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NCT02091960 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
A Phase 2 study of Advanced Breast Cancer and HER2 Amplified, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT02091960: Completed Phase 2 study of Advanced Breast Cancer and HER2 Amplified, sponsored by Astellas Pharma Global Development.
NCT02091960 is a Phase 2 study of Advanced Breast Cancer and HER2 Amplified that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 103 participants, below the 461-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02091960, a Phase 2 study of Advanced Breast Cancer and HER2 Amplified, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
Primary Outcome
Clinical benefit rate was defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or prolonged stable disease (≥ 24 weeks). Complete response (CR) was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all \< 10 mm in short axis. Partial response (PR) was defined as disappearance of target lesions or a ≥ 30%
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Enzalutamide
Study Locations (20)
California
- Site US10051 - Anaheim
- Site US10028 - Los Angeles
- Site US10035 - San Francisco
Tennessee
- Site US10029 - Knoxville
- Site US10042 - Nashville
- Site US10077 - Nashville
Other
- Site BE32013 - Brasschaat
- Site BE32016 - Brussels
- Site BE32001 - Charleroi
Florida
- Site US10079 - Fort Myers
- Site US10074 - Gainesville
Texas
- Site US10076 - Fort Worth
- Site US10082 - Houston
Illinois
- Site US10081 - Chicago
Indiana
- Site US10004 - Indianapolis
Massachusetts
- Site US10070 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2014-09-05 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 2 |
What the finished NCT02091960 record still lists
NCT02091960 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 461-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Advanced Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab is the first listed.
NCT02091960 names 20 study sites across 12 states, led by California, Tennessee, Other.
Frequently Asked Questions
What is clinical trial NCT02091960 about?
NCT02091960 is a clinical study titled "A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer". The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
What is the current status of trial NCT02091960?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2014-09-05. Estimated completion is 2024-01-30.
What conditions does trial NCT02091960 study?
This clinical trial studies the following conditions: Advanced Breast Cancer, HER2 Amplified, Human Epidermal Growth Factor Receptor 2 (HER2).
What interventions are being tested in trial NCT02091960?
The interventions under investigation include: Trastuzumab (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02091960?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02091960 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02091960's enrollment target sits among peer trials
103 20th of 28 higher than 9 of 28 other Advanced Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Breast Cancer 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.
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