Home › Trials › NCT05161195

Continued access to ribociclib for metastatic breast cancer patients

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 4 Interventional Novartis · NCT05161195

This study is testing if continuing ribociclib treatment is safe and helpful for people with metastatic breast cancer who have already benefited from it in a previous study.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment137 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations74 sites (Chandler, Arizona and 73 other locations)
Trial IDNCT05161195 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center roll-over study aims to evaluate the long-term safety of ribociclib in combination with other treatments for participants who have completed a parent study. Eligible patients are those who have been receiving ribociclib for at least six cycles and are deemed by the investigator to benefit from continued treatment. The study provides an opportunity for patients to maintain access to ribociclib after the primary objectives of the parent study have been met.

Who should consider this trial

Good fit: Ideal candidates are patients currently participating in a Novartis-sponsored study who have been receiving ribociclib and show evidence of clinical benefit.

Not a fit: Patients who have permanently discontinued ribociclib or have unresolved toxicities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide ongoing treatment options for patients with metastatic breast cancer, potentially improving their outcomes.

How similar studies have performed: Other studies have shown success with similar approaches in providing continued access to effective treatments for cancer patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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

Key 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

Other protocol-defined inclusion/exclusion criteria may apply at the end

Where this trial is running

Chandler, Arizona and 73 other locations

+24 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Breast CancerRoll-over ProtocolRibociclibHR-positiveHER2-negativeBreast CancerRibociclib in combination with other drugsLEE011
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.