Observational study of Ribociclib with hormonal therapy for advanced 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
This study is trying to see how safe Ribociclib is when used with hormonal therapy for people with advanced breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 4 sites (Amman and 3 other locations) |
| Trial ID | NCT06075758 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to collect real-world safety data on approximately 550 patients with HR+/HER2- advanced or metastatic breast cancer who have received Ribociclib in combination with hormonal therapy. The study will include both ambispective patients currently on treatment and retrospective patients who have completed treatment. Data will be gathered from electronic medical records across selected sites in Middle Eastern countries, focusing on adverse events and treatment outcomes over a maximum follow-up period of six months. The recruitment period is set for six months, targeting patients who meet specific eligibility criteria related to their treatment history.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with HR+/HER2- advanced or metastatic breast cancer who have received or are currently receiving Ribociclib with hormonal therapy.
Not a fit: Patients with HER2-positive breast cancer or those who have not received Ribociclib in combination with hormonal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of Ribociclib combined with hormonal therapy for patients with advanced breast cancer.
How similar studies have performed: Previous studies have shown success with similar approaches in evaluating the safety and efficacy of Ribociclib in breast cancer treatment, indicating a promising avenue for this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy. 2. Advanced /metastatic breast cancer 3. Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer. 4. HER2-negative breast cancer. 5. Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice. 6. 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. 7. 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 8. For ambispective part, patients agree to sign informed consent before their enrollment. Exclusion Criteria: 1. Ribociclib-based treatment regimen beyond the second line. 2. Patients are currently participating in any other clinical trials. 3. Patient with a known hypersensitivity to any of the excipients of Ribociclib. 4. Patients who previously received any other CDK4/6 inhibitor . 5. For ambispective patients, patients who refuse to sign the informed consent
Where this trial is running
Amman and 3 other locations
- Novartis Investigative Site — Amman, Jordan (Recruiting)
- Novartis Investigative Site — Muscat, Oman (Recruiting)
- Novartis Investigative Site — Riyadh, Saudi Arabia (Recruiting)
- Novartis Investigative Site — Al Ain Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.