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NCT02941926 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
A Phase 3 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,246
- Enrollment target
- 20
- Study locations
NCT02941926: Completed Phase 3 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT02941926 is a Phase 3 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 3,246 participants, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02941926, a Phase 3 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,246 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..
Primary Outcome
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s). SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization. A SAE which caused death of the participant was considered
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Goserelin
- DRUG Ribociclib
- DRUG Leuprolide
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- Pacific Shores Medical Group SC - Long Beach
- USC Norris Cancer Center - Los Angeles
- University of California Irvine UC Irvine (11) - Orange
- Ventura County Hematology and Oncology - Oxnard
- PCR Oncology - Pismo Beach
- California Pacific Medical Center Onc Dept - San Francisco
Florida
- Florida Cancer Research Institute Dept of Oncology - Davie
- Foundation for Sickle Cell Disease Research - Hollywood
- Watson Clinic Center for Research 1730 Location - Lakeland
- Mid Florida Hematology and Onc Ctr - Orange
Arizona
- Ironwood Cancer and Research Centers - Chandler
- Arizona Oncology Associates - Phoenix
- Arizona Oncology Associates Arizona Oncology Assoc. (2) - Tucson
Colorado
- Centura Health Research Center Centura Health Research Center - Denver
- Poudre Valley Hospital Poudre Valley Health System - Fort Collins
- Valley View Hospital Cancer Center - Glenwood Springs
Alaska
- Alaska Cancer Research and Education Center - Anchorage
Arkansas
- Highlands Oncology Group - Fayetteville
Georgia
- Summit Cancer Care Summit Cancer Care (SC) - Savannah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,246 participants |
| Start Date | 2016-11-30 |
| Est. Completion | 2022-11-09 |
| Phase | Phase 3 |
What the finished NCT02941926 record still lists
NCT02941926 is an interventional study that assigns participants to a tested intervention. Its 3,246 participants enrollment target places it among the larger protocols in the corpus, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.
NCT02941926 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02941926 about?
NCT02941926 is a clinical study titled "Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC". The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..
What is the current status of trial NCT02941926?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,246 participants. The study started on 2016-11-30. Estimated completion is 2022-11-09.
What conditions does trial NCT02941926 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02941926?
The interventions under investigation include: Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT02941926?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02941926 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT02941926's enrollment target sits among peer trials
3,246 47th of 1224 higher than 1,178 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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