Breast Cancer Clinical Trial
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.
The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer
Eligibility Criteria
Inclusion Criteria:
Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
Patient is premenopausal or perimenopausal at the time of study entry
Patients who received (neo) adjuvant therapy for breast cancer are eligible
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
Patient has HER2-negative breast cancer
Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient has adequate bone marrow and organ function
Exclusion Criteria:
Patient who has received a prior CDK4/6 inhibitor
Patient is postmenopausal
Patients who currently have inflammatory breast cancer at screening.
Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
Patient with CNS metastases.
Patient has active cardiac disease or a history of cardiac dysfunction
Patient is currently using other antineoplastic agents
Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception
Other protocol-defined Inclusion/Exclusion may apply.
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There are 171 Locations for this study
Bakersfield California, 93309, United States
Los Angeles California, 90095, United States
Denver Colorado, 80218, United States
Danbury Connecticut, 06810, United States
Fort Myers Florida, 33901, United States
Fort Myers Florida, 33901, United States
Hollywood Florida, 33021, United States
Miami Florida, 33136, United States
Marietta Georgia, 30060, United States
Honolulu Hawaii, 96817, United States
Chicago Illinois, 60637, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
Neptune New Jersey, 07754, United States
Albuquerque New Mexico, 87106, United States
Lake Success New York, 11042, United States
Durham North Carolina, 27710, United States
Hershey Pennsylvania, 17033, United States
Greenville South Carolina, 29607, United States
Chattanooga Tennessee, 37403, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78234, United States
Ogden Utah, 84403, United States
Midlothian Virginia, 23114, United States
Everett Washington, 98201, United States
Kennewick Washington, 99336, United States
Tacoma Washington, 98405, United States
Madison Wisconsin, 53792, United States
Cordoba , X5004, Argentina
Jujuy , 4600, Argentina
La Rioja , 5300, Argentina
Waratah New South Wales, 2298, Australia
Box Hill Victoria, 3128, Australia
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Bruxelles , 1000, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Londrina PR, 86015, Brazil
Ijuà RS, 98700, Brazil
Passo Fundo RS, 99010, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 04014, Brazil
São Paulo SP, 01509, Brazil
Sofia , 1303, Bulgaria
Varna , 9010, Bulgaria
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Quebec , G1S 4, Canada
Bogota , 11022, Colombia
Monteria , , Colombia
Strasbourg Cedex Cedex, F 670, France
Caen Cedex , 14021, France
Lille Cedex , 59020, France
Lyon Cedex , 69373, France
Montpellier Cedex 5 , 34298, France
Paris , 75015, France
Rouen Cedex 1 , 76038, France
Toulouse Cedex 9 , 31059, France
Muehlhausen Thueringen, 99974, Germany
Bonn , 53111, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Esslingen , 73730, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Muenchen , 81377, Germany
Offenbach , 63069, Germany
Ravensburg , 88214, Germany
Ulm , 89081, Germany
Thessaloniki GR, 54645, Greece
Heraklion Crete , 711 1, Greece
Hong Kong , , Hong Kong
Kowloon , , Hong Kong
Budapest , 1134, Hungary
Budapest , H 112, Hungary
Budapest , H-103, Hungary
Debrecen , 4032, Hungary
Szeged , 6720, Hungary
Szolnok , H-500, Hungary
Bangalore Karnataka, 560 0, India
Nashik Maharashtra, 422 0, India
Kolkatta West Bengal, 700 0, India
Mumbai , 400 0, India
L'Aquila AQ, 67100, Italy
Benevento BN, 82100, Italy
Bologna BO, 40138, Italy
Cremona CR, 26100, Italy
Catania CT, 95124, Italy
Meldola FC, 47014, Italy
Cona FE, 44100, Italy
Genova GE, 16132, Italy
Lecce LE, 73100, Italy
Lucca LU, 55100, Italy
Macerata MC, 62100, Italy
Milano MI, 20141, Italy
Perugia PG, 06129, Italy
Prato PO, 59100, Italy
Pavia PV, 27100, Italy
Roma RM, 00168, Italy
Candiolo TO, 10060, Italy
Terni TR, 05100, Italy
Udine UD, 33100, Italy
Napoli , 80131, Italy
Bundang Gu Gyeonggi Do, 13620, Korea, Republic of
Gyeonggi do Korea, 10408, Korea, Republic of
Seoul Korea, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
El Chouf LBN, 15032, Lebanon
Ashrafieh , 16683, Lebanon
Beirut , 1107 , Lebanon
Beirut , 16637, Lebanon
Beirut , , Lebanon
Saida , 652, Lebanon
Johor Bahru Johor, 81100, Malaysia
Kuala Lumpur , 59100, Malaysia
Metepec Edo. De México, 01722, Mexico
Leon Guanajuato, 37000, Mexico
Monterrey Nuevo Leon Monterrey, 64710, Mexico
Gdansk , 80 95, Poland
Konin , 62 50, Poland
Lisboa , 1099 , Portugal
Lisboa , 1400-, Portugal
Lisboa , 1500 , Portugal
Porto , 4200 , Portugal
Porto , 4200-, Portugal
Arkhangelsk , 16304, Russian Federation
Saint Petersburg , 19214, Russian Federation
Riyadh , 11426, Saudi Arabia
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Elche Alicante, 03203, Spain
Almeria Andalucia, 04009, Spain
Malaga Andalucia, 29010, Spain
Sabadell Barcelona, 08208, Spain
Sant Joan Despi Barcelona, 08970, Spain
Badalona Catalunya, 08916, Spain
Barcelona Catalunya, 08003, Spain
Barcelona Catalunya, 08035, Spain
Valencia Comunidad Valenciana, 46010, Spain
Santiago de Compostela Galicia, 15706, Spain
Mallorca Islas Baleares, 07198, Spain
Alcorcon Madrid, 28922, Spain
San Sebastian Pais Vasco, 20080, Spain
Baracaldo Vizcaya, 48903, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Geneve , 1205, Switzerland
New Taipei City TWN, 23561, Taiwan
Changhua , 50006, Taiwan
Kaohsiung City , 83301, Taiwan
Taipei , 10002, Taiwan
Taipei , 10449, Taiwan
Taipei , 11217, Taiwan
Taipei , , Taiwan
Taoyuan , 33305, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10700, Thailand
Istanbul TUR, 34098, Turkey
Adana , 01160, Turkey
Ankara , 06100, Turkey
Diyarbakir , 21000, Turkey
Edirne , 22030, Turkey
Izmir , 35040, Turkey
Al Ain Abu Dhabi , , United Arab Emirates
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