Breast Cancer Clinical Trial

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

Summary

This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient is an adult male/female ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer.
Patient must have either measurable disease by RECIST 1.1 or at least one predominantly lytic bone lesion.

Patient has advanced (loco regionally recurrent not amenable to curative therapy, e.g. surgery and/or radiotherapy, or metastatic) breast cancer.

Patients may be:

newly diagnosed advanced/metastatic breast cancer, treatment naïve
relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease
newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor)
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient has adequate bone marrow and organ function

Exclusion Criteria:

Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.
Patient with inflammatory breast cancer at screening .
Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion to starting the study treatment and have stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality

Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to start the treatment:

Known strong inducers or inhibitors of CYP3A4/5,
That have a known risk to prolong the QT interval or induce Torsades de Pointes.
Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
Herbal preparations/medications, dietary supplements.

Other Protocol-defined Inclusion/Exclusion may apply.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

726

Study ID:

NCT02422615

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 171 Locations for this study

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Southern Cancer Center PC SC-2
Mobile Alabama, 36608, United States
Ironwood Cancer and Research Centers SC-2
Chandler Arizona, 85224, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Central Coast Medical Oncology Corporation SC
Santa Maria California, 93454, United States
St Joseph Heritage Healthcare
Santa Rosa California, 94503, United States
Poudre Valley Hospital
Fort Collins Colorado, 80528, United States
Florida Cancer Research Institute Dept of Oncology
Davie Florida, 33328, United States
Florida Hospital Cancer Institute SC
Orlando Florida, 32804, United States
UF Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
John D Archbold Memorial Hospital Main
Thomasville Georgia, 31792, United States
Moanalua Medical Center. Attn: Oncology Dept SC
Honolulu Hawaii, 96817, United States
Oncology Specialists, SC Advocate Medical Group-Niles
Park Ridge Illinois, 60068, United States
Jackson Oncology Associates SC
Jackson Mississippi, 39202, United States
Meridian Health Systems Regulatory
Neptune New Jersey, 07753, United States
University of New Mexico Cancer Center SC
Albuquerque New Mexico, 87131, United States
CR Wood Cancer Center SC
Glens Falls New York, 12801, United States
Clinical Research Alliance
Lake Success New York, 11042, United States
NYU Langone Medical Center CV Research center NYU Langone Medical Center
New York New York, 10016, United States
Genesis Cancer Services SC
Zanesville Ohio, 43701, United States
Penn State University Milton S Hershey Medical Center SC
Hershey Pennsylvania, 17033, United States
Millennium Research Clin Develop SC
Houston Texas, 77090, United States
Northern Utah Cancer Associates SC
Ogden Utah, 84403, United States
Providence Regional Cancer Partnership
Everett Washington, 98201, United States
Providence Regional Cancer System SC
Lacey Washington, 98503, United States
Virginia Mason Medical Center-Oncology SC
Seattle Washington, 98101, United States
Novartis Investigative Site
St Leonards New South Wales, 2065, Australia
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Herston Queensland, 4029, Australia
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East Melbourne Victoria, 3002, Australia
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Nedlands Western Australia, 6009, Australia
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Innsbruck Tyrol, 6020, Austria
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Vienna , A-110, Austria
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Wien , A-109, Austria
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Aalst , 9300, Belgium
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Charleroi , 6000, Belgium
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Hasselt , 3500, Belgium
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Leuven , 3000, Belgium
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Liege , 4000, Belgium
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Namur , 5000, Belgium
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Sofia , 1303, Bulgaria
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Sofia , 1606, Bulgaria
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Sofia , 1756, Bulgaria
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Surrey British Columbia, V3V 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Victoria British Columbia, V8R 6, Canada
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Moncton New Brunswick, E1C 8, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Brampton Ontario, L6R 3, Canada
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Kingston Ontario, K7L 5, Canada
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Newmarket Ontario, J7Y 2, Canada
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Montréal Quebec, H3G 1, Canada
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Rimouski Quebec, G5L 5, Canada
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Sherbrooke Quebec, J1H 5, Canada
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Trois Rivieres Quebec, G8Z 3, Canada
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Bogota , 11022, Colombia
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Monteria , , Colombia
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Brno Bohunice Czech Republic, 625 0, Czechia
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Liberec Czech Republic, 46063, Czechia
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Brno , 65653, Czechia
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Prague 8 , 180 8, Czechia
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Praha , 12808, Czechia
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Aalborg , DK 90, Denmark
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Aarhus , DK-80, Denmark
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Copenhagen , DK-21, Denmark
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Herlev , 2730, Denmark
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Odense C , DK 50, Denmark
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Vejle , 7100, Denmark
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Strasbourg Cedex Cedex, F 670, France
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Saint-Cloud Hauts De Seine, 92210, France
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Reims Cedex Marne, 51056, France
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Besancon Cedex , 25030, France
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Bordeaux Cedex , 33000, France
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Bordeaux , 33076, France
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Brest , 29200, France
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Creteil , 94000, France
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Le Mans Cedex , 72015, France
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Lille Cedex , 59020, France
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Limoges , 87000, France
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Paris Cedex 13 , 75651, France
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Pierre Benite Cedex , 69495, France
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Toulon La Seyne Sur Mer , 83056, France
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Langen Hessen, 63225, Germany
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Georgsmarienhuette Lower Saxony, 49124, Germany
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Augsburg , 86150, Germany
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Berlin , 10117, Germany
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Berlin , 10967, Germany
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Bielefeld , 33604, Germany
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Bonn , 53111, Germany
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Dresden , 01307, Germany
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Erlangen , 91054, Germany
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Fuerth , 90766, Germany
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Hamburg , 22081, Germany
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Hamburg , 22767, Germany
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Hannover , 30559, Germany
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Heidelberg , 69115, Germany
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Koeln , 50935, Germany
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Luebeck , 23538, Germany
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Muenchen , 80637, Germany
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Mühlhausen , 99974, Germany
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Oldenburg , 26121, Germany
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Ravensburg , 88214, Germany
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Saarbruecken , 66113, Germany
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Troisdorf , 53840, Germany
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Tübingen , 72076, Germany
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Velbert , 42551, Germany
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Weiden , 92637, Germany
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Budapest , 1134, Hungary
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Budapest , H 112, Hungary
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Budapest , H-103, Hungary
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Debrecen , 4032, Hungary
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Szolnok , H-500, Hungary
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L'Aquila AQ, 67100, Italy
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Brescia BS, 25123, Italy
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Catania CT, 95124, Italy
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Lecce LE, 73100, Italy
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Milano MI, 20133, Italy
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Rozzano MI, 20089, Italy
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Pontedera PI, 56025, Italy
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Napoli , 80131, Italy
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Amman , 11941, Jordan
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Ashrafieh , 16683, Lebanon
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Beirut , 1107 , Lebanon
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Johor Bahru Johor, 81100, Malaysia
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Kuching Sarawak, 93586, Malaysia
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Oaxaca , 68000, Mexico
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Amsterdam , 1066 , Netherlands
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Breda , 4819 , Netherlands
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Den Haag , 2545 , Netherlands
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Deventer , 7416 , Netherlands
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Enschede , 7513 , Netherlands
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Groningen , 9728 , Netherlands
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Hoofddorp , 2134 , Netherlands
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Maastricht , 6229 , Netherlands
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Nieuwegein , 3435 , Netherlands
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Roermond , 6043 , Netherlands
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Sittard-Geleen , 6162 , Netherlands
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Tilburg , 5042 , Netherlands
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Oslo , NO 04, Norway
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Konin , 62 50, Poland
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Warszawa , 04-12, Poland
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Lisboa , 1400-, Portugal
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Porto , 4200-, Portugal
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Arkhangelsk , 16304, Russian Federation
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Tambov , 39200, Russian Federation
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Singapore , 11922, Singapore
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Granada Andalucia, 18014, Spain
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Malaga Andalucia, 29010, Spain
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Sevilla Andalucia, 41014, Spain
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Sevilla Andalucia, 41017, Spain
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Sant Joan Despi Barcelona, 08970, Spain
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Salamanca Castilla Y Leon, 37007, Spain
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Barcelona Catalunya, 08036, Spain
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A Coruna Galicia, 15009, Spain
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Alcorcon Madrid, 28922, Spain
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San Sebastian de los Reyes Madrid, 28702, Spain
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Madrid , 28009, Spain
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Madrid , 28222, Spain
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Eskilstuna , SE-63, Sweden
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Sundsvall , 851 8, Sweden
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Vaxjo , SE-35, Sweden
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Aarau , 5000, Switzerland
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Basel , 4031, Switzerland
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Zuerich , 8038, Switzerland
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Istanbul , 34303, Turkey
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Istanbul , 34381, Turkey
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Istanbul , 34662, Turkey
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Izmir , , Turkey
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Plymouth Devon, PL6 8, United Kingdom
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Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

726

Study ID:

NCT02422615

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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