Clinical trial · Observational
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
NCT06797531CI-TRIAL-00116956NISLEESArecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.
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 |
|---|---|---|---|
| HR+/HER2- Early Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Ribocliclib
- description
- HR+/HER2- early breast cancer patients who have been newly receiving ribociclib for up to 6 months prior to enrollment
- interventionNames
- Drug: ribociclib
Primary outcomes (1)
- measure
- Invasive Breast Cancer-Free Survival (iBCFS)
- timeFrame
- 36 months
- description
- iBCFS, defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or invasive contralateral BC. iBCFS will be assessed using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant BC Clinical Trials), as assessed by the investigator, in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
Secondary outcomes (10)
- measure
- Invasive disease free survival (iDFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.