Clinical trials: Ribociclib
Metastatic Breast Cancer
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative…
- Trial name
- NCT07148505
- Where
- United States
- Volunteers
- 373 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
EGFR-mutant Non-small Cell Lung Cancer
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced Epidermal growth factor…
- Trial name
- NCT03333343
- Testing
- EGF816, trametinib, ribociclib
- Where
- 11 sites in Canada, Germany and 4 more
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- 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
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the…
- Trial name
- NCT01857193
- Testing
- ribociclib (LEE011), Exemestane, Everolimus (RAD001)
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
This study was planned as a prospective multicenter NIS. This study was observational in nature and did not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule.
- Trial name
- PROSPERITY (NCT04943497)
- Testing
- ribociclib, aplelicib, mono endocrine therapy
- Where
- 57 sites in Russia
- Volunteers
- 2,390 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Roll-over Study to Allow Continued Access to Ribociclib
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in…
- Trial name
- NCT05161195
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 73 sites in United States, Argentina and 20 more
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Early Breast Cancer
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
- Trial name
- MONALEESA-1 (NCT01919229)
- Testing
- LEE011 (ribociclib), letrozole
- Where
- 7 sites in United States, Singapore and 1 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Locally Advanced Metastatic BRAF Mutant Melanoma
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.
To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
- Trial name
- NCT01777776
- Testing
- LEE011, LGX818
- Where
- 9 sites in United States, Australia and 2 more
- Volunteers
- 28 people
- Sponsor
- Array BioPharma
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the…
- Trial name
- LOGIC-2 (NCT02159066)
- Testing
- LGX818, MEK162, LEE011
- Where
- 32 sites in United States, Australia and 7 more
- Volunteers
- 158 people
- Sponsor
- Pfizer
Breast Cancer
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice
This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor…
- Trial name
- IMPULSE (NCT06905301)
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 7 sites in Russia
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
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…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
HR+HER2- Advanced Breast Cancer
A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia
This is а prospective, non-interventional, primary data collection cohort study to evaluate the clinical outcomes of the combination of ribociclib + ET and combination chemotherapy in the real-life setting in Russia.
- Trial name
- ValerEE (NCT06148506)
- Testing
- Ribociclib, Combination chemotherapy
- Where
- 20 sites in Russia
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast…
- Trial name
- NCT06075758
- Testing
- ribociclib
- Where
- 3 sites in Jordan, Oman and 1 more
- Volunteers
- 175 people
- Sponsor
- Novartis Pharmaceuticals
Liposarcoma
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma
To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.
- Trial name
- NCT02343172
- Testing
- HDM201, LEE011
- Where
- 9 sites in Canada, France and 4 more
- Volunteers
- 74 people
- Sponsor
- Novartis Pharmaceuticals