Roll-over Study to Allow Continued Access to Ribociclib

JRCT ID: jRCT2031220246

Registered date:05/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: HR positive, HER2 negative advanced breast cancer
• Date of first enrollment: 19/07/2022
• Target sample size: 5
• Countries of recruitment: South Korea,Japan,Hong Kong,Japan,Australia,Japan,Brazil,Japan,Colombia,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Mexico,Japan,Poland,Japan,Portugal,Japan,Singapore,Japan,South Africa,Japan,Spain,Japan,Turkey,Japan,US,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Percentage of participants with treatment-emergent adverse events (AEs) [ Time Frame: From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years ]: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 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)
2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
3. Currently has evidence of clinical benefit as determined by the Investigator

Exclude criteria

1. Permanent discontinuation of ribociclib in the parent study
2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study
3. Local access to commercially available ribociclib and reimbursed

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT05161195