Clinical trials: Ribociclib
Low Grade Serous Carcinoma
Ribociclib and Letrozole Treatment in Ovarian Cancer
The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.
- Trial name
- NCT03673124
- Testing
- Ribociclib, Letrozole
- Where
- 27 sites in United States
- Volunteers
- 51 people
- Sponsor
- Gynecologic Oncology Group
Breast Cancer Metastatic
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at…
- Trial name
- AMICA (NCT03555877)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- Germany
- Volunteers
- 56 people
- Sponsor
- GBG Forschungs GmbH
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Hormon Receptor Positive Breast Cancer, Breast Cancer
Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective…
- Trial name
- CADILLAC (NCT07195227)
- Testing
- Camizestrant, Ribociclib
- Where
- 16 sites in Germany, Spain
- Volunteers
- 150 people
- Sponsor
- MedSIR
Breast Cancer
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer.
- Trial name
- NCT06587789
- Testing
- Ribociclib
- Where
- China
- Volunteers
- 286 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Neoplasms
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with…
- Trial name
- NEOLBC (NCT03283384)
- Testing
- Letrozole, Chemotherapy, Ribociclib plus letrozole
- Where
- 29 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Borstkanker Onderzoek Groep
Advanced, Metastatic Breast Cancer
A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Letrozole SIE (injectable) compared to Femara® (oral tablet), both given together with ribociclib, for the first-line treatment of postmenopausal women with…
- Trial name
- SIE-3 (NCT07340658)
- Volunteers
- 300 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Breast Cancer
A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American…
- Trial name
- NCT07760714
- Where
- United States
- Volunteers
- 945 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node…
- Trial name
- NCT06996093
- Testing
- 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- Where
- China
- Volunteers
- 2,508 people
- Sponsor
- Fudan University
Advanced Breast Cancer
A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer
This is a Phase I study to assess the safety and Maximum tolerated dose (MTD) of paclitaxel + ribociclib (LEE011) in patients with Rb+, advanced breast cancer.
- Trial name
- NCT02599363
- Testing
- Ribociclib (LEE011), Paclitaxel
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer
A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients
The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer…
- Trial name
- CATTALYST (NCT07710716)
- Where
- Switzerland
- Volunteers
- 3,000 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone…
- Trial name
- EarLEE-2 (NCT03081234)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Sponsor
- Novartis Pharmaceuticals
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Breast Cancer Stage II
Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in…
- Trial name
- RIBOLARIS (NCT05296746)
- Testing
- Ribociclib (neoadjuvant), Chemotherapy (adjuvant), Ribociclib (adjuvant)
- Where
- 51 sites in France, Portugal and 1 more
- Volunteers
- 1,100 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Cancer
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0…
- Trial name
- FELINE (NCT02712723)
- Testing
- Letrozole, Ribociclib
- Where
- 13 sites in United States
- Volunteers
- 121 people
- Sponsor
- Qamar Khan
Malignant Solid Tumor
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.
This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts…
- Trial name
- MegaMOST (NCT04116541)
- Testing
- HDM201, Ribociclib, Cabozantinib
- Where
- 13 sites in France
- Volunteers
- 455 people
- Sponsor
- Centre Leon Berard
Liposarcomas, Dedifferentiated, Liposarcoma - Well Differentiated
A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma
The purpose of this study is to determine whether ribociclib are effective and safe in the treatment of progressive well/dedifferentiated liposarcoma (WDL/DDL).
- Conditions
- Liposarcomas, Dedifferentiated, Liposarcoma - Well Differentiated, Liposarcoma; Mixed Type, Soft-Tissue Sarcoma
- Trial name
- NCT03096912
- Testing
- Ribociclib
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Assaf-Harofeh Medical Center
CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma
Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors
This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment.
- Conditions
- CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma, Recurrent Atypical Teratoid/Rhabdoid Tumor, Recurrent Childhood Ependymoma
- Trial name
- NCT03387020
- Testing
- Everolimus, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 12 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pediatric Brain Tumor Consortium
Tumors With CDK4/6 Pathway Activation
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
- Trial name
- SIGNATURE (NCT02187783)
- Testing
- LEE011
- Where
- 61 sites in United States
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company