Clinical Trial: NCT01958021
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2025-03-07 |
Study Overview
Brief Summary
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.
Official Title
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Conditions
Advanced, Metastatic Breast Cancer
Intervention / Treatment
- Drug: Ribociclib
- Drug: Letrozole
- Drug: Placebo
Other Study ID Numbers
- CLEE011A2301
- 2013-003084-61
Start Date (Actual)
2013-12-17
Primary Completion Date (Actual)
2016-01-29
Study Completion Date (Actual)
2023-03-16
Enrollment (Actual)
668
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Novartis Pharmaceuticals |
| Information Provided By: | Novartis |
| Last Update Posted: | 2025-03-07 |
Study Overview
Brief Summary
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.
Official Title
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Conditions
Advanced, Metastatic Breast Cancer
Intervention / Treatment
- Drug: Ribociclib
- Drug: Letrozole
- Drug: Placebo
Other Study ID Numbers
- CLEE011A2301
- 2013-003084-61
Start Date (Actual)
2013-12-17
Primary Completion Date (Actual)
2016-01-29
Study Completion Date (Actual)
2023-03-16
Enrollment (Actual)
668
Study Type
Interventional
Phase
Phase 3