Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ribociclib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ribociclib ambispective
- description
- Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first.
- interventionNames
- Other: ribociclib
- label
- ribociclib retrospective
- description
- Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment
- interventionNames
- Other: ribociclib
Primary outcomes (1)
- measure
- AEs/SAEs/ severity and frequency
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available