Roll-over Study to Allow Continued Access to Ribociclib

Last updated: January 30, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Breast Cancer

Metastatic Cancer

Treatment

Goserelin

Letrozole

Fulvestrant

Clinical Study ID

NCT05161195
CLEE011A2412B
2024-514891-41-00
2021-005184-42
  • Ages 18-100
  • All Genders

Study Summary

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 combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

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:

  1. Total abstinence

  2. Female sterilization

  3. Male partner sterilization

  4. 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

Total Participants: 134
Treatment Group(s): 6
Primary Treatment: Goserelin
Phase: 4
Study Start date:
July 07, 2022
Estimated Completion Date:
August 14, 2030

Study Description

This is an open-label, multi-center, roll-over study to evaluate the long-term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study.

Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.

Connect with a study center

  • Novartis Investigative Site

    San Juan, J5402DIL
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Juan 3837213, J5402DIL
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Natal, RN 59075 740
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Ijui, RS 98700-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Ijuí, RS 98700-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Natal 3394023, Rio Grande do Norte 3390290 59075 740
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Ijuí 3461444, Rio Grande do Sul 3451133 98700-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Florianopolis, SC 88020-210
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 03102
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, SP 03102
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Florianópolis 3463237, Santa Catarina 3450387 88020-210
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Jose Rio Preto, 15090 000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São José do Rio Preto 3448639, 15090 000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo 3448439, 01255-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Chongqing, Chongqing 404100
    China

    Site Not Available

  • Novartis Investigative Site

    Chongqing 1814906, Chongqing Municipality 1814905 404100
    China

    Site Not Available

  • Novartis Investigative Site

    Shijiazhuang, Hebei 050011
    China

    Site Not Available

  • Novartis Investigative Site

    Shijiazhuang 1795270, Hebei 1808773 050011
    China

    Site Not Available

  • Novartis Investigative Site

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Novartis Investigative Site

    Harbin 2037013, Heilongjiang 2036965 150081
    China

    Site Not Available

  • Novartis Investigative Site

    Changsha, Hunan 410013
    China

    Site Not Available

  • Novartis Investigative Site

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • Novartis Investigative Site

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Novartis Investigative Site

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • Novartis Investigative Site

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • Novartis Investigative Site

    Suzhou 1886760, Jiangsu 1806260 215004
    China

    Site Not Available

  • Novartis Investigative Site

    Chang Chun, Jilin 130021
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Novartis Investigative Site

    Kunming, Yunnan 650106
    China

    Site Not Available

  • Novartis Investigative Site

    Kunming 1804651, Yunnan 1785694 650106
    China

    Site Not Available

  • Novartis Investigative Site

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • Novartis Investigative Site

    Hangzhou 1808926, Zhejiang 1784764 310006
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100036
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing 1816670, 100036
    China

    Site Not Available

  • Novartis Investigative Site

    Qingdao, 266000
    China

    Site Not Available

  • Novartis Investigative Site

    Qingdao 1797929, 266000
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai, 200032
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai 1796236, 200032
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin, 300480
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin 1792947, 300480
    China

    Site Not Available

  • Novartis Investigative Site

    San Jose, 95008
    Costa Rica

    Site Not Available

  • Novartis Investigative Site

    San José 3621849, 95008
    Costa Rica

    Site Not Available

  • Novartis Investigative Site

    Heraklion Crete, 715 00
    Greece

    Site Not Available

  • Novartis Investigative Site

    Heraklion Crete., 715 00
    Greece

    Site Not Available

  • Novartis Investigative Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Hong Kong 1819729, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Pokfulam, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin, HONGKONG
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Bhubaneshwar, Odisha 1261029 751007
    India

    Site Not Available

  • Novartis Investigative Site

    Delhi, 110 085
    India

    Site Not Available

  • Novartis Investigative Site

    Delhi 1273294, 110085
    India

    Site Not Available

  • Novartis Investigative Site

    Meldola, FC 47014
    Italy

    Site Not Available

  • Novartis Investigative Site

    Meldola 3173635, FC 47014
    Italy

    Site Not Available

  • Novartis Investigative Site

    Osaka-city, Osaka 540-0006
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka 1853909, Osaka 1853904 5400006
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8677
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto ku, Tokyo 135 8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1850144 1138431
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto Ku, Tokyo 1850144 1358550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Chouf, LBN 1503201002
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    El Chouf, LBN 1503201002
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Beirut 276781, 113-0236
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Monterrey Nuevo Leon, Monterrey 64710
    Mexico

    Site Not Available

  • Novartis Investigative Site

    San Pedro G G, 66278
    Mexico

    Site Not Available

  • Novartis Investigative Site

    San Pedro Garza Garcia, 66278
    Mexico

    Site Not Available

  • Novartis Investigative Site

    San Pedro Garza García 4005937, 66278
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Trujillo, La Libertad 13011
    Peru

    Site Not Available

  • Novartis Investigative Site

    Trujillo 3691175, La Libertad 3695781 13011
    Peru

    Site Not Available

  • Novartis Investigative Site

    San Borja, Lima 41
    Peru

    Site Not Available

  • Novartis Investigative Site

    San Borja 3929792, Lima region 3936452 41
    Peru

    Site Not Available

  • Novartis Investigative Site

    Gdansk, 80 952
    Poland

    Site Not Available

  • Novartis Investigative Site

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Novartis Investigative Site

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Lisbon 2267057, 1400-038
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Loures, 2674514
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Loures 2266977, 2674-514
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Porto, 4200-072
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Porto 2735943, 4200-072
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Singapore, 119228
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Singapore 1880252, 119228
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Cape Town, 7500
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Cape Town 3369157, 7500
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Johannesburg, 2196
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Johannesburg 993800, 2196
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria, 0002
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria 964137, 0002
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Seoul 1835848, Korea 03080
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Sant Joan Despi, Barcelona 08970
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sant Joan Despí 3110519, Barcelona 08970
    Spain

    Site Not Available

  • Novartis Investigative Site

    Taipei, 11217
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Diyarbakir, 21000
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Kecioren Ankara, 06010
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Malatya, 44280
    Turkey

    Site 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 States

    Site Not Available

  • Ironwood Cancer and Research Centers

    Chandler 5289282, Arizona 5551752 85224
    United States

    Site Not Available

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Highlands Oncology Group

    Fayetteville 4110486, Arkansas 4099753 72703
    United States

    Site Not Available

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Beverly Hills Cancer Center

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Poudre Valley Hospital

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Poudre Valley Hospital

    Fort Collins 5577147, Colorado 5417618 80528
    United States

    Site Not Available

  • Mid Florida Hematology and Onc Ctr

    Orange, Florida 32763
    United States

    Site Not Available

  • Mid Florida Hematology and Onc Ctr

    Orange City, Florida 32763
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Mid Florida Hematology And Onc Ctr

    Orange 4167034, Florida 4155751 32763
    United States

    Site Not Available

  • Summit Cancer Care

    Savannah, Georgia 31405
    United States

    Site Not Available

  • John D Archbold Memorial Hospital

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • Summit Cancer Care

    Savannah 4221552, Georgia 4197000 31405
    United States

    Site Not Available

  • John D Archbold Memorial Hospital

    Thomasville 4226348, Georgia 4197000 31792
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Duly Health and Care

    Plainfield, Illinois 60585
    United States

    Site Not Available

  • Duly Health and Care

    Plainfield 4906125, Illinois 4896861 60585
    United States

    Site Not Available

  • Indian Univ Health Goshen Center forCancer

    Goshen, Indiana 46526
    United States

    Site Not Available

  • Indiana University Health Goshen Center for Cancer

    Goshen, Indiana 46526
    United States

    Active - Recruiting

  • Indian Univ Health Goshen Center forCancer

    Goshen 4920808, Indiana 4921868 46526
    United States

    Site Not Available

  • Northern Light Mercy Hospital

    Portland, Maine 04102
    United States

    Site Not Available

  • Northern Light Mercy Hospital

    Portland 4975802, Maine 4971068 04102
    United States

    Site Not Available

  • Englewood Health

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • The Valley Hospital / Luckow Pavillion

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • The Valley Hospital Luckow Pavillion

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • The Valley Hospital-Luckow Pavillion

    Paramus, New Jersey 07652
    United States

    Site Not Available

  • Englewood Health

    Englewood 5097672, New Jersey 5101760 07631
    United States

    Site Not Available

  • The Valley Hospital-Luckow Pavillion

    Paramus 5102387, New Jersey 5101760 07652
    United States

    Site Not Available

  • Eastchester Center for Cancer Care

    Bronx, New York 10469
    United States

    Site Not Available

  • Eastchester Center for Cancer Care

    The Bronx 5110266, New York 5128638 10469
    United States

    Site Not Available

  • University Hospitals of Cleveland Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals of Cleveland Seidman Cancer Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

    Site Not Available

  • Millennium Research Clin Develop

    Houston, Texas 77090
    United States

    Site Not Available

  • Millennium Research Clin Develop

    Houston 4699066, Texas 4736286 77090
    United States

    Site Not Available

  • Novartis Investigative Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Novartis Investigative Site

    Hanoi 1581130, 100000
    Vietnam

    Site Not Available

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