A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

Launched by NOVARTIS PHARMACEUTICALS · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called ribociclib works when combined with other hormone therapies in older patients (65 years and older) who have advanced breast cancer that is hormone receptor-positive and HER2-negative. The goal is to understand how effective this treatment is, how safe it is, and how it affects the quality of life for these patients in everyday medical practice in Russia. The study is currently recruiting participants who have started this treatment within the last four weeks.

To be eligible for this trial, participants must be at least 65 years old and have a confirmed diagnosis of advanced breast cancer that cannot be treated with surgery. They should also be starting treatment with ribociclib along with hormone therapy. However, patients who are expected to live less than three months or have certain heart conditions cannot participate. Those who join the study will help researchers gather real-world data on this treatment's outcomes, which could be very important for improving care for older patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 65 years at the moment of ribociclib+ET initiation
• • 2. Female/Male gender
• • 3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment
• • 4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
• • 5. Provision of written informed consent.
• Exclusion Criteria:
• • 1. Patients with a life expectancy of less than 3 months per the investigator's judgment
• • 2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study)
• • 3. Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
• • 4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).