17 active not recruiting. 17 Phase 2, 5 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 17 | Active not recruiting 17 |
| Phase 1 | 5 | Active not recruiting 5 |
Follow ribociclib: new trials by email Literature Review of ribociclib trials Research Report on ribociclib
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 |
|---|---|---|---|---|---|---|
| A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors AZD8421, Camizestrant, Ribociclib - ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC) | Phase 1 / Phase 2 | Active not recruiting | AstraZeneca | 55 | 2023-12-05 | 2026-10-28 |
| Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI - Breast Cancer, ER-positive Breast Cancer | Phase 2 | Active not recruiting | University of Miami | 24 | 2023-06-12 | 2026-01-13 |
| Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer Elacestrant, Alpelisib, Everolimus - Breast Cancer, Metastatic Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Stemline Therapeutics, Inc. | 435 | 2023-01-24 | 2026-06-12 |
| Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression Ipatasertib 300mg, Fulvestrant 500g, Palbociclib 75mg-125mg - Metastatic Breast Cancer, ER+ Breast Cancer | Phase 2 | Active not recruiting | Royal Marsden NHS Foundation Trust | 57 | 2022-12-28 | 2026-04-14 |
| Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer Ribociclib (neoadjuvant), Chemotherapy (adjuvant), Ribociclib (adjuvant) - Breast Cancer Stage II | Phase 2 | Active not recruiting | SOLTI Breast Cancer Research Group | 1100 | 2022-05-03 | 2026-05-14 |
| Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer Carboplatin, Docetaxel, Fulvestrant - Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8 | Phase 1 / Phase 2 | Active not recruiting | Jonsson Comprehensive Cancer Center | 18 | 2022-04-07 | 2026-05-11 |
| Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma LXH254, LTT462, Trametinib - Melanoma | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 134 | 2020-10-30 | 2026-03-12 |
| Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer. Letrozole, Chemotherapy, Ribociclib plus letrozole - Breast Neoplasms | Phase 2 | Active not recruiting | Borstkanker Onderzoek Groep | 100 | 2019-06-15 | 2026-10-01 |
| Ribociclib and Letrozole Treatment in Ovarian Cancer Ribociclib, Letrozole - Low Grade Serous Carcinoma | Phase 2 | Active not recruiting | Gynecologic Oncology Group | 51 | 2019-05-20 | 2025-12-23 |
| FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer Ribociclib, Aromatase Inhibitors, non steroideal, LHRH agonist - Breast Cancer | Phase 2 | Active not recruiting | Fondazione Sandro Pitigliani | 116 | 2018-12-27 | 2025-02-26 |
| Ribociclib and Bicalutamide in AR+ TNBC ribociclib, Bicalutamide - Triple Negative Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Kari Wisinski | 37 | 2018-05-07 | 2026-01-02 |
| CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer Ribociclib, Endocrine therapy - Breast Cancer | Phase 2 | Active not recruiting | Massachusetts General Hospital | 120 | 2017-12-12 | 2025-12-22 |
| A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma Everolimus, Letrozole, Ribociclib - Recurrent Endometrial Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma | Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 90 | 2017-08-18 | 2026-05-22 |
| Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) Ribociclib, Everolimus - Soft Tissue Sarcoma | Phase 2 | Active not recruiting | Fox Chase Cancer Center | 48 | 2017-08-08 | 2026-05-22 |
| Ribociclib (LEE011) Rollover Study for Continued Access LEE011 - Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 22 | 2016-12-15 | 2026-04-16 |
| Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer Letrozole, Ribociclib, Placebo - Breast Cancer | Phase 2 | Active not recruiting | Qamar Khan | 121 | 2016-02-01 | 2026-03-11 |
| Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer LEE011, Letrozole, BYL719 - Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 259 | 2013-10-22 | 2026-09-18 |
Breast Neoplasms (9) · Cystadenocarcinoma, Serous (1) · Endometrial Neoplasms (1) · Leiomyosarcoma (1) · Liposarcoma (1) · Melanoma (1) · Sarcoma (1) · Triple Negative Breast Neoplasms (1)
Novartis Pharmaceuticals (3) · AstraZeneca (1) · Borstkanker Onderzoek Groep (1) · Fondazione Sandro Pitigliani (1) · Fox Chase Cancer Center (1) · Gynecologic Oncology Group (1) · Jonsson Comprehensive Cancer Center (1) · Kari Wisinski (1) · M.D. Anderson Cancer Center (1) · Massachusetts General Hospital (1) · Qamar Khan (1) · Royal Marsden NHS Foundation Trust (1) · SOLTI Breast Cancer Research Group (1) · Stemline Therapeutics, Inc. (1) · University of Miami (1)
United States (13) · France (5) · Spain (5) · United Kingdom (5) · Australia (4) · Italy (4) · South Korea (3) · Argentina (2) · Belgium (2) · Germany (2) · Israel (2) · Netherlands (2) · Switzerland (2) · Brazil (1) · Luxembourg (1)
A. E van Leeuwen-Stok, PhD (1) · Aleix Prat, MD (1) · Alicia Okines (1) · Arielle Medford, MD (1) · Brian Slomovitz, MD (1) · Frances Valdes-Albini, MD (1) · Gerrit-Jan Liefers, MD PhD (1) · Judith R Kroep, MD PhD (1) · Kari Wisinski, MD (1) · Laura Biganzoli, MD (1) · Margaret von Mehren, MD (1) · Nicholas P McAndrew (1) · Pamela T Soliman (1)
PMID 35587446, PMID 36800111, PMID 42334791, PMID 42602220, PMID 42823426
2023 (2), 2017 (1)