Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France

Launched by NOVARTIS PHARMACEUTICALS · Jan 16, 2023

Keywords

ClinConnect Summary

The RosaLEE study is looking at how well the medication ribociclib works when combined with other hormone therapies in women with a specific type of breast cancer known as HR+/HER2- that is locally advanced or has spread (metastatic). This research is being conducted in multiple centers across France and is focused on women who have already made the decision to start this treatment before joining the study. The goal is to understand the real-world experiences and outcomes of these patients while they receive this treatment.

To participate in this study, women must be at least 18 years old and have been diagnosed with the specified type of breast cancer. They should also be pre-, peri-, or postmenopausal and have agreed to take part in the study. However, those who have already started certain treatments related to ribociclib or who are pregnant cannot participate. Participants can expect to share their treatment experiences and outcomes, which will help researchers learn more about the effectiveness and impact of ribociclib in everyday clinical practice.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Patients who meet all of the following criteria will be included in the RosaLEE study:
• • 1. Adult women aged ≥ 18 years old at inclusion.
• • 2. Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC.
• • 3. Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization.
• • 4. Patients having given their non-objection to participate in the study.
• • 5. Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics.
• Exclusion Criteria:
• • 1. Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion.
• • 2. Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion.
• • 3. Patients for whom AI or fulvestrant in monotherapy has been initiated \> 28 days before inclusion.
• • 4. Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC.
• • 5. Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.