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

Inclusion Criteria8

Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
Advanced /metastatic breast cancer
Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
HER2-negative breast cancer.
Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit.
For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment
For ambispective part, patients agree to sign informed consent before their enrollment.

Exclusion Criteria5

Ribociclib-based treatment regimen beyond the second line.
Patients are currently participating in any other clinical trials.
Patient with a known hypersensitivity to any of the excipients of Ribociclib.
Patients who previously received any other CDK4/6 inhibitor .
For ambispective patients, patients who refuse to sign the informed consent

Interventions

OTHERribociclib

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