Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Beverly Hills, California and other locations
Dates
study started
completion around

Description

Summary

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

Official Title

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

Details

The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study

Keywords

Metastatic Breast Cancer, Roll-over Protocol, Ribociclib, HR-positive, HER2-negative, Breast Cancer, Ribociclib in combination with other drugs, LEE011, Breast Neoplasms, Tamoxifen, Letrozole, Fulvestrant, Anastrozole, Goserelin

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills California 90211 United States
  • Ironwood Cancer and Research Centers accepting new patients
    Chandler Arizona 85224 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05161195
Phase
Phase 4 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 137 study participants
Last Updated