5 completed, 2 active not recruiting, 1 terminated, 1 withdrawn. 9 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 5, Active not recruiting 2, Terminated 1, Withdrawn 1 |
Follow Lee011: new trials by email Literature Review of Lee011 trials Research Report on Lee011
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase IIIb Study of Ribociclib + ET in Early Breast Cancer Ribociclib, Letrozole, Ansastrozole - Early Breast Cancer | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 1466 | 2024-02-28 | 2026-11-03 |
| A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer Ribociclib, Endocrine Therapy (ET) - Early Breast Cancer | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 5101 | 2018-12-07 | 2026-10-09 |
| Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer Ribociclib, Placebo, Adjuvant endocrine therapy - Breast Cancer | Phase 3 | Withdrawn | Novartis Pharmaceuticals | 2018-03-31 | 2018-03-15 | |
| Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant Ribociclib, Letrozole, Alpelisib - Breast Cancer | Phase 3 | Terminated | Novartis Pharmaceuticals | 287 | 2018-02-02 | 2026-07-10 |
| 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 Ribociclib, Letrozole, Goserelin - Breast Cancer | Phase 3 | Completed | Novartis Pharmaceuticals | 3246 | 2016-11-30 | 2023-10-24 |
| Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer ribociclib, letrozole, goserelin - Advanced Metastatic Breast Cancer | Phase 3 | Completed | Novartis Pharmaceuticals | 502 | 2016-10-24 | 2021-10-11 |
| Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. Ribociclib, Fulvestrant, Placebo - Advanced Breast Cancer | Phase 3 | Completed | Novartis Pharmaceuticals | 726 | 2015-06-09 | 2023-11-30 |
| Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Ribociclib, Tamoxifen, Letrozole - Advanced Metastatic Breast Cancer | Phase 3 | Completed | Novartis Pharmaceuticals | 672 | 2014-11-20 | 2024-03-12 |
| Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer Ribociclib, Letrozole, Placebo - Advanced, Metastatic Breast Cancer | Phase 3 | Completed | Novartis Pharmaceuticals | 668 | 2013-12-17 | 2025-03-07 |
Breast Neoplasms (8) · Breast Diseases (1) · Breast Neoplasms, Male (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Multiple Endocrine Neoplasia Type 1 (1) · Neoplasms (1) · Neoplasms by Site (1) · Osteitis Deformans (1)
Canada (6) · Germany (6) · Italy (6) · United States (6) · Argentina (5) · Australia (5) · Belgium (5) · France (5) · Hungary (5) · Russia (5) · South Korea (5) · Spain (5) · Taiwan (5) · Austria (4) · Brazil (4)
PMID 42334791, PMID 31305131, PMID 33769862, PMID 34158598, PMID 36800111, PMID 37673211, PMID 39826197, PMID 17513820, PMID 27717303, PMID 29404806, PMID 29718092, PMID 29804902, PMID 29860922, PMID 30340505, PMID 31166679, PMID 31826360, PMID 34102253, PMID 34414532, PMID 34504990, PMID 34953442, PMID 34965945, PMID 35212906, PMID 35263519, PMID 36152144, PMID 36206609, PMID 36267663, PMID 36861085, PMID 37275963, PMID 37653397, PMID 38107828, PMID 38507751, PMID 40996773
2016 (2), 2014 (1), 2015 (1), 2017 (1), 2023 (1)