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

EU CTIS

Registry ID

CTIS2024-514891-41-00

Acronym

CLEE011A2412B

Enrollment

Registered

2024-08-05

Start date

2022-07-19

Completion date

Unknown

Last updated

2025-06-03

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

Conditions

HER2- advanced or metastatic breast cancer, HR+

Brief summary

Frequency and severity of AEs/SAEs, Proportion of participants with clinical benefit as assessed by the Investigator

Interventions

DRUGTAMOXIFEN

DRUGLEE011

DRUGRIBOCICLIB

DRUGLETROZOLE

DRUGGOSERELIN ACETATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs/SAEs, Proportion of participants with clinical benefit as assessed by the Investigator	—

Countries

Greece, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026