A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study

Phase 1

• Conditions: HR+, HER2- advanced or metastatic breast cancer; MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864; MedDRA version: 27.0Level: PTClassification code: 10055113Term: Breast cancer metastatic Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-514891-41-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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.

Exclusion Criteria

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., 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)., 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: a) Total abstinence b) Female sterilization c) Male partner sterilization d) Placement of an intrauterine device (IUD)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long-term safety as assessed by occurrence of adverse events of ribociclib as part of a combination regimen;Secondary Objective: To evaluate clinical benefit as assessed by the Investigator;Primary end point(s): Frequency and severity of AEs/SAEs, Proportion of participants with clinical benefit as assessed by the Investigator