RecruitingNCT06075758

A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer

Real-World Evidence Study for the Safety and Effectiveness of Ribociclib in Combination With Hormonal Therapy in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer in the Middle East Region

Sponsor

Novartis Pharmaceuticals

Enrollment

550 participants

Start Date

Mar 7, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on how well ribociclib — a targeted cancer drug — works when combined with hormonal therapy in women with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. **You may be eligible if...** - You are 18 years old or older - You have advanced or metastatic breast cancer that is estrogen receptor-positive and/or progesterone receptor-positive - Your cancer tests HER2-negative - You are receiving or have received ribociclib combined with hormonal therapy **You may NOT be eligible if...** - Your breast cancer is HER2-positive - Your cancer is hormone receptor-negative - You have not been treated with ribociclib plus hormonal therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERribociclib

There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.