NCT06075758Completed
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 175 (actual)
- First submitted
- 4 Oct 2023
- Start date
- 7 Mar 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06075758
What you commit to
- Study type: Observational
- Participants enrolled: 175
- From 7 Mar 2024 to the primary completion date, 30 Jun 2025
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously received any other CDK4/6 inhibitor .
Other illness
- Patient with a known hypersensitivity to any of the excipients of Ribociclib.
Other
- Ribociclib-based treatment regimen beyond the second line.
- Patients are currently participating in any other clinical trials.
- For ambispective patients, patients who refuse to sign the informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Al Ain Abu Dhabi | United Arab Emirates | Unknown status |
| - Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
| - Coordinator of this site? Confirm its status | Muscat | Oman | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.