RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Launched by NOVARTIS PHARMACEUTICALS · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called ribociclib for patients with a specific type of early breast cancer known as HR+/HER2- breast cancer. The trial will look at how well ribociclib works when combined with other hormone treatments in real-life settings, rather than in a controlled lab environment. It is open to men and women aged 18 and older who are currently receiving ribociclib as part of their treatment for early breast cancer. To join, participants should have certain characteristics, such as having breast cancer that tests positive for estrogen or progesterone receptors and being in specific stages of the disease.

Participants in this study can expect to help researchers gather important information about their treatment experiences over time. This information will include how the drug affects their health and any potential side effects. It’s important to note that individuals who have received certain other cancer treatments or are currently involved in other clinical trials may not be eligible to participate. Overall, this study aims to provide valuable insights into ribociclib’s role in treating early breast cancer in a real-world setting in Saudi Arabia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated Patient Informed Consent Form (PICF) obtained.
• • 2. The patient is ≥ 18 years-old at the time of PICF signature.
• • 3. Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
• • 4. Male or female patients with HER2- BC.
• • 5. Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date.
• • 6. Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) /IIB or Anatomic Stage Group III EBC.
• • 7. Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male.
• Exclusion Criteria:
• • 1. Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
• • 2. Patients are currently participating in any other clinical trials.
• • 3. Patients who previously received any other CDK4/6 inhibitor.
• • 4. Patients who refused to sign informed consent.
• • 5. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reason.