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NCT01783444 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
A Phase 2 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 309
- Enrollment target
- 20
- Study locations
NCT01783444 is a Phase 2 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 309 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01783444, a Phase 2 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 309 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Exemestane
- DRUG Everolimus
Study Locations (20)
Tennessee
- Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology - Chattanooga
- The Jones Clinic SC - Germantown
- University of Tennessee SC - Knoxville
- Sarah Cannon Research Institute SC (2) - Nashville
New Jersey
- Trinitas Comprehensive Cancer Center SC - Elizabeth
- Hackensack University Medical Center Dept of Oncology - Hackensack
- Rutgers-New Jersey Medical School SC - Newark
California
- University of California at Los Angeles Mattel Children's Hospital - Los Angeles
- Sharp Memorial Hospital SharpClinicalOncologyResearch - San Diego
Florida
- Florida Cancer Specialists Dept of Oncology (2) - Fort Myers
- Florida Cancer Specialists FL Cancer Specialists - Fort Myers
Massachusetts
- Lahey Clinic Dept of Lahey Clinic (2) - Burlington
- New England Hematology/ Oncology Associates, P.C. SC - Newton
Montana
- Glacier View Research Institute - Cancer SC - Kalispell
Ohio
- Oncology Hematology Care Inc Oncology Hematology Care 2 - Cincinnati
Oklahoma
- Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2013-02-26 |
| Est. Completion | 2018-07-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01783444
The ClinicalTrials.gov registry entry for NCT01783444 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT01783444 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Tennessee, New Jersey, California.
Frequently Asked Questions
What is clinical trial NCT01783444 about?
NCT01783444 is a clinical study titled "A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.". This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor posi...
What is the current status of trial NCT01783444?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 309 participants. The study started on 2013-02-26. Estimated completion is 2018-07-30.
What conditions does trial NCT01783444 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01783444?
The interventions under investigation include: Capecitabine (DRUG), Exemestane (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT01783444?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01783444 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Montana, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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