RIBOCICLIB for Hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- 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).\n- Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.\n- Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.\n- Participant must have evidence of clinical benefit as determined by the Investigator."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Participants currently have 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).\n- Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).\n- 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: a) Total abstinence b) Female sterilization c) Male partner sterilization d) Placement of an intrauterine device (IUD)\n"}

Primary endpoints

• {"endpoint_text":"- Frequency and severity of AEs/SAEs","definition_or_measurement_approach":"Measured as occurrence, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) reported during study treatment; overall objective: to evaluate long-term safety as assessed by occurrence of adverse events of ribociclib as part of a combination regimen."}
• {"endpoint_text":"- Proportion of participants with clinical benefit as assessed by the Investigator","definition_or_measurement_approach":"Clinical benefit assessed by the Investigator (proportion of participants with clinical benefit at scheduled visits as determined by the Investigator)."}

Greece

Latest Decision Or Authorization Date

22-08-2024

Number Of Sites

1

Number Of Participants

1

Poland

Latest Decision Or Authorization Date

07-08-2024

Number Of Sites

1

Number Of Participants

1

Italy

Latest Decision Or Authorization Date

09-08-2024

Number Of Sites

1

Number Of Participants

1

Spain

Latest Decision Or Authorization Date

05-08-2024

Number Of Sites

1

Number Of Participants

1

Portugal

Latest Decision Or Authorization Date

07-08-2024

Number Of Sites

3

Number Of Participants

3

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PRA Hellas CRO A.E.

Responsibilities

code 1

Name

IQVIA Limited

Responsibilities

code 3

Name

Syneos Health Inc.

Responsibilities

code 1

Name

Parexel International (IRL) Limited

Responsibilities

code 12

Name

Opis S.r.l.

Responsibilities

code 15 (TMF archive)

Third parties

• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"code 15 (TMF archive)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}