Roll-over Study to Allow Continued Access to Ribociclib

NCT05161195 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: CLEE011A2412B2024-514891-41-00
• Study Type: interventional
• Target: 134
• Locations: 22 countries
• Sites: 73

Brief 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).

Conditions

Metastatic Breast Cancer

Keywords

Roll-over Protocol; Post Trial Access (PTA); Ribociclib (LEE011); Ribociclib in combination with other drugs; Hormone Receptor (HR); HR-positive; Human Epidermal Growth Factor Receptor 2 (HER2); HER2-negative; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with treatment-emergent adverse events (AES)

  The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment

  From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years

Secondary Outcomes (1)

• Clinical benefit rate

  Up to 8 years

Study Arms (1)

Ribociclib

OTHER

Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).

Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole; Drug: Goserelin; Drug: Tamoxifen; Drug: Fulvestrant

Interventions

Ribociclib DRUG

Participants continue ribociclib as was administered in their parent study

Also known as: LEE011

Ribociclib

Letrozole DRUG

Participants continue ribociclib in combination with letrozole as was administered in their parent study

Ribociclib

Anastrozole DRUG

Participants continue ribociclib in combination with anastrozole as was administered in their parent study

Ribociclib

Goserelin DRUG

Participants continue ribociclib in combination with goserelin as was administered in their parent study

Ribociclib

Tamoxifen DRUG

Participants continue ribociclib in combination with tamoxifen as was administered in their parent study

Ribociclib

Fulvestrant DRUG

All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Ribociclib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs and the parent study has fulfilled its primary objective(s).
• Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
• Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
• Participant must have evidence of clinical benefit as determined by the Investigator.

You may not qualify if:

• Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
• Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
• Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
• Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective 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 unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (73)

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80528, United States

Location

Mid Florida Hematology And Onc Ctr

Orange, Florida, 32763, United States

Location

Summit Cancer Care

Savannah, Georgia, 31405, United States

Location

John D Archbold Memorial Hospital

Thomasville, Georgia, 31792, United States

Location

Duly Health and Care

Plainfield, Illinois, 60585, United States

Location

Indian Univ Health Goshen Center forCancer

Goshen, Indiana, 46526, United States

Location

Northern Light Mercy Hospital

Portland, Maine, 04102, United States

Location

Englewood Health

Englewood, New Jersey, 07631, United States

Location

The Valley Hospital-Luckow Pavillion

Paramus, New Jersey, 07652, United States

Location

Eastchester Center for Cancer Care

The Bronx, New York, 10469, United States

Location

University Hospitals of Cleveland Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74136, United States

Location

Millennium Research Clin Develop

Houston, Texas, 77090, United States

Location

Novartis Investigative Site

San Juan, J5402DIL, Argentina

Location

Novartis Investigative Site

Natal, Rio Grande do Norte, 59075 740, Brazil

Location

Novartis Investigative Site

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

Location

Novartis Investigative Site

Florianópolis, Santa Catarina, 88020-210, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01317 000, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 03102, Brazil

Location

Novartis Investigative Site

Sao Jose Rio Preto, 15090 000, Brazil

Location

Novartis Investigative Site

São Paulo, 01255-000, Brazil

Location

Novartis Investigative Site

Chongqing, Chongqing Municipality, 404100, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050011, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150081, China

Location

Novartis Investigative Site

Changsha, Hunan, 410013, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

Location

Novartis Investigative Site

Changchun, Jilin, 130021, China

Location

Novartis Investigative Site

Kunming, Yunnan, 650106, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310006, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310016, China

Location

Novartis Investigative Site

Beijing, 100036, China

Location

Novartis Investigative Site

Qingdao, 266000, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Tianjin, 300480, China

Location

Novartis Investigative Site

San José, 95008, Costa Rica

Location

Novartis Investigative Site

Heraklion Crete., 715 00, Greece

Location

Novartis Investigative Site

Hong Kong, 999077, Hong Kong

Location

Novartis Investigative Site

Bhubaneshwar, Odisha, 751007, India

Location

Novartis Investigative Site

Delhi, 110085, India

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Osaka, Osaka, 5400006, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 1138431, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 1138677, Japan

Location

Novartis Investigative Site

Koto Ku, Tokyo, 135-8550, Japan

Location

Novartis Investigative Site

El Chouf, LBN, 1503201002, Lebanon

Location

Novartis Investigative Site

Beirut, 113-0236, Lebanon

Location

Novartis Investigative Site

Beirut, 166830, Lebanon

Location

Novartis Investigative Site

San Pedro G G, 66278, Mexico

Location

Novartis Investigative Site

Trujillo, La Libertad, 13011, Peru

Location

Novartis Investigative Site

San Borja, Lima region, 41, Peru

Location

Novartis Investigative Site

Gdansk, 80-214, Poland

Location

Novartis Investigative Site

Lisbon, 1400-038, Portugal

Location

Novartis Investigative Site

Loures, 2674-514, Portugal

Location

Novartis Investigative Site

Porto, 4200-072, Portugal

Location

Novartis Investigative Site

Singapore, 119228, Singapore

Location

Novartis Investigative Site

Cape Town, 7500, South Africa

Location

Novartis Investigative Site

Johannesburg, 2196, South Africa

Location

Novartis Investigative Site

Pretoria, 0002, South Africa

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Sant Joan Despí, Barcelona, 08970, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, 11217, Taiwan

Location

Novartis Investigative Site

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Novartis Investigative Site

Diyarbakır, Sur, 21280, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

Location

Novartis Investigative Site

Kecioren Ankara, 06010, Turkey (Türkiye)

Location

Novartis Investigative Site

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib; Letrozole; Anastrozole; Goserelin; Tamoxifen; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: July 7, 2022
• Primary Completion (Estimated): June 28, 2030
• Study Completion (Estimated): August 14, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (7); CN (15); SG (1); ES (1); TW (2); LE (3); VN (1); US (16); AR (1); IN (2); KR (2); JP (4); TU (4); CO (1); IT (1); ME (1); PE (2); PL (1); PT (3); ZA (3); HK (1); GR (1)