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Clinical trials for Ribociclib

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   37210   clinical trials with a EudraCT protocol, of which   6122   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
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    19 result(s) found for: Ribociclib. Displaying page 1 of 1.
    EudraCT Number: 2016-000293-37 Sponsor Protocol Number: CLEE011X2X01B Start Date*: 2016-12-05
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: An open-label, multi-center rollover protocol for patients who have participated in a Novartis-sponsored ribociclib (LEE011) study and are continuing to benefit from ribociclib as single agent or i...
    Medical condition: different types of advanced cancer
    Disease:
    Population Age: Children, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003467-19 Sponsor Protocol Number: CLEE011A2404 Start Date*: 2016-12-08
    Sponsor Name:Novartis Pharma AG
    Full Title: COMPLEEMENT-1: An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal wo...
    Medical condition: hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Ongoing) NL (Ongoing) HU (Ongoing) BG (Ongoing) PT (Ongoing) GR (Ongoing) SK (Ongoing) IT (Ongoing) CZ (Ongoing) AT (Completed) ES (Ongoing) DK (Ongoing) NO (Completed) PL (Ongoing) FI (Completed) SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004234-15 Sponsor Protocol Number: CLEE011A2207 Start Date*: 2019-05-21
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre- an...
    Medical condition: HR-positive, HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    21.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    21.1 100000004864 10072737 Advanced breast cancer LLT
    20.0 100000004864 10073289 Premenopausal breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Ongoing) CZ (Ongoing) FR (Ongoing) LT (Ongoing) AT (Ongoing) FI (Ongoing) DE (Ongoing) PT (Ongoing) HU (Ongoing) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002998-21 Sponsor Protocol Number: CLEE011O12301C Start Date*: 2019-02-25
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-...
    Medical condition: hormone receptor-positive, HER2-negative, early breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006203 Breast cancer stage unspecified LLT
    21.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Ongoing) ES (Ongoing) IE (Ongoing) HU (Ongoing) AT (Ongoing) BE (Ongoing) FR (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002556-24 Sponsor Protocol Number: CLEE011XDE01 Start Date*: 2016-10-14
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A national phase IIIb, multi-center, open label study for women and men with hormone-receptor positive, HER2-negative locally advanced or metastatic breast cancer treated with ribociclib (LEE011) i...
    Medical condition: HR+, HER2- advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000617-43 Sponsor Protocol Number: CLEE011F2301 Start Date*: 2015-05-27
    Sponsor Name:Novartis Pharma Services AG
    Full Title: MONALEESA-3: A randomized double-blind, placebo-controlled study of ribociclib in combination with fulvestrant for the treatment of men and postmenopausal women with hormone receptor positive, HER2...
    Medical condition: men and postmenopausal women with HR+, HER2-negative advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) DE (Ongoing) AT (Ongoing) ES (Ongoing) CZ (Ongoing) DK (Ongoing) NL (Ongoing) HU (Ongoing) BE (Ongoing) BG (Ongoing) FR (Ongoing) PT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005019-34 Sponsor Protocol Number: CTMT212X2106 Start Date*: 2016-05-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase I/II study of safety and efficacy of ribociclib (LEE011) in combination with trametinib (TMT212) in patients with metastatic or advanced solid tumors
    Medical condition: Solid tumors, Pancreatic Cancer, Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049280 Solid tumour LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033604 Pancreatic cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-003648-22 Sponsor Protocol Number: SAKK_2118 Start Date*: 2020-01-10
    Sponsor Name:SAKK
    Full Title: Ribociclib-endocrine combination therapy versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer. A multicenter, randomized phase III trial.
    Medical condition: Histologically or cytologically confirmed diagnosis of HR-positive, HER2-negative advanced stage breast cancer with measurable visceral metastases .
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003667-35 Sponsor Protocol Number: GBG-97-AMICA Start Date*: 2017-12-29
    Sponsor Name:GBG Forschungs GmbH
    Full Title: Anti-hormonal maintenance treatment with the CDK4/6 inhibitor Ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial
    Medical condition: HR-positive/HER2-negative metastatic breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003098-17 Sponsor Protocol Number: SOLTI-1402 Start Date*: 2017-03-29
    Sponsor Name:SOLTI
    Full Title: CORALLEEN: A Phase 2 Clinical Trial of multi-agent Chemotherapy or letrozole plus Ribociclib (LEE001) as neoadjuvant treatment for postmenopausal patients with Luminal B/HER2-negative breast cancer.
    Medical condition: Luminal B/HER2-negative breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000133-40 Sponsor Protocol Number: CSET-2016/2369-ITCC-057 Start Date*: 2018-04-05
    Sponsor Name:Gustave Roussy
    Full Title: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
    Medical condition: Relapsed or refractory tumors in children
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Ongoing) GB (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000676-29 Sponsor Protocol Number: BOOG-2017-01 Start Date*: 2018-01-12
    Sponsor Name:BOOG Study Center
    Full Title: Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer.
    Medical condition: Mamma carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002930-22 Sponsor Protocol Number: IOM-050371 Start Date*: 2018-02-14
    Sponsor Name:iOMEDICO AG
    Full Title: A randomized, open-label, multicenter, two-arm, phase III study to evaluate efficacy and quality of life in patients with metastatic hormone receptor-positive HER2-negative breast cancer receiving ...
    Medical condition: The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001795-53 Sponsor Protocol Number: CLEE011G2301 Start Date*: 2017-11-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone r...
    Medical condition: Hormone receptor-positive, Estrogen and/or progesterone receptor-positive, HER2-negative, High risk early breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020819 10006203 Breast cancer stage unspecified LLT
    20.0 100000115074 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Ongoing) CZ (Ongoing) BE (Completed) NL (Ongoing) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002249-22 Sponsor Protocol Number: D-V Start Date*: 2015-07-15
    Sponsor Name:Universitätsklinikum Ulm (AöR)
    Full Title: DETECT V/CHEVENDO: A multicenter, randomized phase III study to compare chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pert...
    Medical condition: Patients with HER2-positive and hormone-receptor positive metastatic breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003084-61 Sponsor Protocol Number: CLEE011A2301 Start Date*: 2014-01-24
    Sponsor Name:Novartis Pharma Services AG
    Full 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 ...
    Medical condition: HR+, HER2- advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Ongoing) DE (Ongoing) CZ (Ongoing) ES (Ongoing) SE (Ongoing) NL (Ongoing) HU (Ongoing) FI (Ongoing) IE (Ongoing) BE (Ongoing) DK (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001931-36 Sponsor Protocol Number: CLEE011E2301 Start Date*: 2014-12-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III randomized, double-blind, placebo-controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the t...
    Medical condition: premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Ongoing) DE (Ongoing) BE (Ongoing) IT (Ongoing) PT (Ongoing) PL (Ongoing) BG (Ongoing) ES (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000610-38 Sponsor Protocol Number: CPDR001J2201 Start Date*: 2018-10-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
    Medical condition: Unresectable or metastatic melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Ongoing) FR (Ongoing) DE (Temporarily Halted) NL (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000428-12 Sponsor Protocol Number: CLEE011X2201 Start Date*: 2014-10-24
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable teratoma with recent progression
    Medical condition: relapsed, refractory, incurable teratoma
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed) FR (Prematurely Ended) NL (Temporarily Halted) DK (Completed)
    Trial results: View results
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