A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01783444
- Run by
- Novartis Pharmaceuticals
- People needed
- 309
- Starts
- 2013-02-26
- Expected to finish
- 2018-07-30
- Last updated by the study team
- 2021-02-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Sharp Memorial Hospital SharpClinicalOncologyResearch — San Diego, California, United States
- Florida Cancer Specialists Dept of Oncology (2) — Fort Myers, Florida, United States
- Florida Cancer Specialists FL Cancer Specialists — Fort Myers, Florida, United States
- Lahey Clinic Dept of Lahey Clinic (2) — Burlington, Massachusetts, United States
- New England Hematology/ Oncology Associates, P.C. SC — Newton, Massachusetts, United States
- Glacier View Research Institute - Cancer SC — Kalispell, Montana, United States
- Trinitas Comprehensive Cancer Center SC — Elizabeth, New Jersey, United States
- Hackensack University Medical Center Dept of Oncology — Hackensack, New Jersey, United States
- Rutgers-New Jersey Medical School SC — Newark, New Jersey, United States
- Oncology Hematology Care Inc Oncology Hematology Care 2 — Cincinnati, Ohio, United States
- Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists — Tulsa, Oklahoma, United States
- Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology — Chattanooga, Tennessee, United States
- The Jones Clinic SC — Germantown, Tennessee, United States
- University of Tennessee SC — Knoxville, Tennessee, United States
- Sarah Cannon Research Institute SC (2) — Nashville, Tennessee, United States
- The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD — Fort Worth, Texas, United States
- University of Virginia Health Systems SC-4 — Charlottesville, Virginia, United States
- Northwest Medical Specialties Dept of Onc — Tacoma, Washington, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Posadas, Misiones Province, Argentina
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
- Novartis Investigative Site — Rio Negro, Viedma, Argentina
- Novartis Investigative Site — Córdoba, Argentina
- Novartis Investigative Site — Randwick, New South Wales, Australia
- University of California at Los Angeles Mattel Children's Hospital — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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