Phase
Condition
Breast Cancer
Metastatic Cancer
Treatment
Goserelin
Letrozole
Fulvestrant
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Participant is currently participating in a Novartis sponsored global study (parentstudy), receiving treatment with ribociclib in combination with other drugs and theparent study has fulfilled its primary objective(s).
Willingness and ability to comply with scheduled visits, treatment plans and anyother study procedures.
Participant must have been receiving treatment with ribociclib for at least 6 cyclesin the parent study.
Participant must have evidence of clinical benefit as determined by theInvestigator.
Exclusion
Key Exclusion Criteria:
Permanent discontinuation of ribociclib in the parent study due to toxicity ordisease progression, non-compliance to study procedures, withdrawal of consent orany other reason as stipulated in parent protocol.
Participant currently has unresolved toxicities for which ribociclib dosing has beeninterrupted in the parent study (participants meeting all other eligibility criteriamay be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
Local access to commercially available ribociclib and reimbursed (except for USenrolled participants from parent protocol CLEE011A2404 meeting all othereligibility criteria).
Women of child-bearing potential defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring the study treatment and for 21 days after stopping the treatment. Highlyeffective contraception methods include:
Total abstinence
Female sterilization
Male partner sterilization
Placement of an intrauterine device (IUD)
- Male contraception during ribociclib use by male participants is not required unlessit is necessary due to the safety profile of other medications a participant istaking or by local regulations.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
San Juan, J5402DIL
ArgentinaSite Not Available
Novartis Investigative Site
San Juan 3837213, J5402DIL
ArgentinaSite Not Available
Novartis Investigative Site
Natal, RN 59075 740
BrazilSite Not Available
Novartis Investigative Site
Ijui, RS 98700-000
BrazilSite Not Available
Novartis Investigative Site
Ijuí, RS 98700-000
BrazilSite Not Available
Novartis Investigative Site
Natal 3394023, Rio Grande do Norte 3390290 59075 740
BrazilSite Not Available
Novartis Investigative Site
Ijuí 3461444, Rio Grande do Sul 3451133 98700-000
BrazilSite Not Available
Novartis Investigative Site
Florianopolis, SC 88020-210
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 03102
BrazilSite Not Available
Novartis Investigative Site
São Paulo, SP 03102
BrazilSite Not Available
Novartis Investigative Site
Florianópolis 3463237, Santa Catarina 3450387 88020-210
BrazilSite Not Available
Novartis Investigative Site
Sao Jose Rio Preto, 15090 000
BrazilSite Not Available
Novartis Investigative Site
Sao Jose do Rio Preto, 15090 000
BrazilSite Not Available
Novartis Investigative Site
Sao Jose do Rio Preto, 15090 000
BrazilSite Not Available
Novartis Investigative Site
São José do Rio Preto 3448639, 15090 000
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, 01255-000
BrazilSite Not Available
Novartis Investigative Site
Chongqing, Chongqing 404100
ChinaSite Not Available
Novartis Investigative Site
Chongqing 1814906, Chongqing Municipality 1814905 404100
ChinaSite Not Available
Novartis Investigative Site
Shijiazhuang, Hebei 050011
ChinaSite Not Available
Novartis Investigative Site
Shijiazhuang 1795270, Hebei 1808773 050011
ChinaSite Not Available
Novartis Investigative Site
Harbin, Heilongjiang 150081
ChinaSite Not Available
Novartis Investigative Site
Harbin 2037013, Heilongjiang 2036965 150081
ChinaSite Not Available
Novartis Investigative Site
Changsha, Hunan 410013
ChinaSite Not Available
Novartis Investigative Site
Changsha 1815577, Hunan 1806691 410013
ChinaSite Not Available
Novartis Investigative Site
Nanjing, Jiangsu 210029
ChinaSite Not Available
Novartis Investigative Site
Suzhou, Jiangsu 215004
ChinaSite Not Available
Novartis Investigative Site
Nanjing 1799962, Jiangsu 1806260 210029
ChinaSite Not Available
Novartis Investigative Site
Suzhou 1886760, Jiangsu 1806260 215004
ChinaSite Not Available
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaSite Not Available
Novartis Investigative Site
Changchun 2038180, Jilin 2036500 130021
ChinaSite Not Available
Novartis Investigative Site
Kunming, Yunnan 650106
ChinaSite Not Available
Novartis Investigative Site
Kunming 1804651, Yunnan 1785694 650106
ChinaSite Not Available
Novartis Investigative Site
Hangzhou, Zhejiang 310006
ChinaSite Not Available
Novartis Investigative Site
Hangzhou 1808926, Zhejiang 1784764 310006
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100036
ChinaSite Not Available
Novartis Investigative Site
Beijing 1816670, 100036
ChinaSite Not Available
Novartis Investigative Site
Qingdao, 266000
ChinaSite Not Available
Novartis Investigative Site
Qingdao 1797929, 266000
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200032
ChinaSite Not Available
Novartis Investigative Site
Shanghai 1796236, 200032
ChinaSite Not Available
Novartis Investigative Site
Tianjin, 300480
ChinaSite Not Available
Novartis Investigative Site
Tianjin 1792947, 300480
ChinaSite Not Available
Novartis Investigative Site
San Jose, 95008
Costa RicaSite Not Available
Novartis Investigative Site
San José 3621849, 95008
Costa RicaSite Not Available
Novartis Investigative Site
Heraklion Crete, 715 00
GreeceSite Not Available
Novartis Investigative Site
Heraklion Crete., 715 00
GreeceSite Not Available
Novartis Investigative Site
Hong Kong, 999077
Hong KongSite Not Available
Novartis Investigative Site
Hong Kong 1819729, 999077
Hong KongSite Not Available
Novartis Investigative Site
Pokfulam, 999077
Hong KongSite Not Available
Novartis Investigative Site
Shatin, HONGKONG
Hong KongSite Not Available
Novartis Investigative Site
Shatin New Territories,
Hong KongSite Not Available
Novartis Investigative Site
Shatin, New Territories,
Hong KongSite Not Available
Novartis Investigative Site
Bhubaneshwar, Odisha 1261029 751007
IndiaSite Not Available
Novartis Investigative Site
Delhi, 110 085
IndiaSite Not Available
Novartis Investigative Site
Delhi 1273294, 110085
IndiaSite Not Available
Novartis Investigative Site
Meldola, FC 47014
ItalySite Not Available
Novartis Investigative Site
Meldola 3173635, FC 47014
ItalySite Not Available
Novartis Investigative Site
Osaka-city, Osaka 540-0006
JapanSite Not Available
Novartis Investigative Site
Osaka 1853909, Osaka 1853904 5400006
JapanSite Not Available
Novartis Investigative Site
Bunkyo ku, Tokyo 113-8677
JapanSite Not Available
Novartis Investigative Site
Koto ku, Tokyo 135 8550
JapanSite Not Available
Novartis Investigative Site
Bunkyo Ku, Tokyo 1850144 1138431
JapanSite Not Available
Novartis Investigative Site
Koto Ku, Tokyo 1850144 1358550
JapanSite Not Available
Novartis Investigative Site
Seoul, 03080
Korea, Republic ofSite Not Available
Novartis Investigative Site
Chouf, LBN 1503201002
LebanonSite Not Available
Novartis Investigative Site
El Chouf, LBN 1503201002
LebanonSite Not Available
Novartis Investigative Site
Ashrafieh, 166830
LebanonSite Not Available
Novartis Investigative Site
Beirut, 1107 2020
LebanonSite Not Available
Novartis Investigative Site
Beirut 276781, 113-0236
LebanonSite Not Available
Novartis Investigative Site
Monterrey Nuevo Leon, Monterrey 64710
MexicoSite Not Available
Novartis Investigative Site
San Pedro G G, 66278
MexicoSite Not Available
Novartis Investigative Site
San Pedro Garza Garcia, 66278
MexicoSite Not Available
Novartis Investigative Site
San Pedro Garza García 4005937, 66278
MexicoSite Not Available
Novartis Investigative Site
Trujillo, La Libertad 13011
PeruSite Not Available
Novartis Investigative Site
Trujillo 3691175, La Libertad 3695781 13011
PeruSite Not Available
Novartis Investigative Site
San Borja, Lima 41
PeruSite Not Available
Novartis Investigative Site
San Borja 3929792, Lima region 3936452 41
PeruSite Not Available
Novartis Investigative Site
Gdansk, 80 952
PolandSite Not Available
Novartis Investigative Site
Gdansk 3099434, 80-214
PolandSite Not Available
Novartis Investigative Site
Lisboa, 1400-038
PortugalSite Not Available
Novartis Investigative Site
Lisbon 2267057, 1400-038
PortugalSite Not Available
Novartis Investigative Site
Loures, 2674514
PortugalSite Not Available
Novartis Investigative Site
Loures 2266977, 2674-514
PortugalSite Not Available
Novartis Investigative Site
Porto, 4200-072
PortugalSite Not Available
Novartis Investigative Site
Porto 2735943, 4200-072
PortugalSite Not Available
Novartis Investigative Site
Singapore, 119228
SingaporeSite Not Available
Novartis Investigative Site
Singapore 1880252, 119228
SingaporeSite Not Available
Novartis Investigative Site
Cape Town, 7500
South AfricaSite Not Available
Novartis Investigative Site
Cape Town 3369157, 7500
South AfricaSite Not Available
Novartis Investigative Site
Johannesburg, 2196
South AfricaSite Not Available
Novartis Investigative Site
Johannesburg 993800, 2196
South AfricaSite Not Available
Novartis Investigative Site
Pretoria, 0002
South AfricaSite Not Available
Novartis Investigative Site
Pretoria 964137, 0002
South AfricaSite Not Available
Novartis Investigative Site
Seoul 1835848, Korea 03080
South KoreaSite Not Available
Novartis Investigative Site
Sant Joan Despi, Barcelona 08970
SpainSite Not Available
Novartis Investigative Site
Sant Joan Despí 3110519, Barcelona 08970
SpainSite Not Available
Novartis Investigative Site
Taipei, 11217
TaiwanSite Not Available
Novartis Investigative Site
Taipei 1668341, 10002
TaiwanSite Not Available
Novartis Investigative Site
Diyarbakir, 21000
TurkeySite Not Available
Novartis Investigative Site
Izmir, 35100
TurkeySite Not Available
Novartis Investigative Site
Kecioren Ankara, 06010
TurkeySite Not Available
Novartis Investigative Site
Malatya, 44280
TurkeySite Not Available
Novartis Investigative Site
Malatya 304922, Battalgazi 44280
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Diyarbakır 316541, Sur 21280
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Izmir 311046, 35100
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Kecioren Ankara, 06010
Turkey (Türkiye)Site Not Available
Ironwood Cancer and Research Centers
Chandler, Arizona 85224
United StatesSite Not Available
Ironwood Cancer and Research Centers
Chandler 5289282, Arizona 5551752 85224
United StatesSite Not Available
Highlands Oncology Group
Fayetteville, Arkansas 72703
United StatesSite Not Available
Highlands Oncology Group
Fayetteville 4110486, Arkansas 4099753 72703
United StatesSite Not Available
Beverly Hills Cancer Center
Beverly Hills, California 90211
United StatesSite Not Available
Beverly Hills Cancer Center
Beverly Hills 5328041, California 5332921 90211
United StatesSite Not Available
Poudre Valley Hospital
Fort Collins, Colorado 80528
United StatesSite Not Available
Poudre Valley Hospital
Fort Collins 5577147, Colorado 5417618 80528
United StatesSite Not Available
Mid Florida Hematology and Onc Ctr
Orange, Florida 32763
United StatesSite Not Available
Mid Florida Hematology and Onc Ctr
Orange City, Florida 32763
United StatesSite Not Available
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United StatesSite Not Available
Mid Florida Hematology And Onc Ctr
Orange 4167034, Florida 4155751 32763
United StatesSite Not Available
Summit Cancer Care
Savannah, Georgia 31405
United StatesSite Not Available
John D Archbold Memorial Hospital
Thomasville, Georgia 31792
United StatesSite Not Available
Summit Cancer Care
Savannah 4221552, Georgia 4197000 31405
United StatesSite Not Available
John D Archbold Memorial Hospital
Thomasville 4226348, Georgia 4197000 31792
United StatesSite Not Available
Joliet Oncology-Hematology Associates
Joliet, Illinois 60435
United StatesSite Not Available
Duly Health and Care
Plainfield, Illinois 60585
United StatesSite Not Available
Duly Health and Care
Plainfield 4906125, Illinois 4896861 60585
United StatesSite Not Available
Indian Univ Health Goshen Center forCancer
Goshen, Indiana 46526
United StatesSite Not Available
Indiana University Health Goshen Center for Cancer
Goshen, Indiana 46526
United StatesActive - Recruiting
Indian Univ Health Goshen Center forCancer
Goshen 4920808, Indiana 4921868 46526
United StatesSite Not Available
Northern Light Mercy Hospital
Portland, Maine 04102
United StatesSite Not Available
Northern Light Mercy Hospital
Portland 4975802, Maine 4971068 04102
United StatesSite Not Available
Englewood Health
Englewood, New Jersey 07631
United StatesSite Not Available
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey 07652
United StatesActive - Recruiting
The Valley Hospital Luckow Pavillion
Paramus, New Jersey 07652
United StatesActive - Recruiting
The Valley Hospital-Luckow Pavillion
Paramus, New Jersey 07652
United StatesSite Not Available
Englewood Health
Englewood 5097672, New Jersey 5101760 07631
United StatesSite Not Available
The Valley Hospital-Luckow Pavillion
Paramus 5102387, New Jersey 5101760 07652
United StatesSite Not Available
Eastchester Center for Cancer Care
Bronx, New York 10469
United StatesSite Not Available
Eastchester Center for Cancer Care
The Bronx 5110266, New York 5128638 10469
United StatesSite Not Available
University Hospitals of Cleveland Seidman Cancer Center
Cleveland, Ohio 44106
United StatesSite Not Available
University Hospitals of Cleveland Seidman Cancer Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma 74136
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institute
Tulsa 4553433, Oklahoma 4544379 74136
United StatesSite Not Available
Millennium Research Clin Develop
Houston, Texas 77090
United StatesSite Not Available
Millennium Research Clin Develop
Houston 4699066, Texas 4736286 77090
United StatesSite Not Available
Novartis Investigative Site
Hanoi, 100000
VietnamSite Not Available
Novartis Investigative Site
Hanoi 1581130, 100000
VietnamSite Not Available

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