Roll-over Study to Allow Continued Access to Ribociclib

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

LBCTR

Registry ID

LBCTR2022095114

Enrollment

Registered

2025-08-14

Start date

2022-12-15

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026