Ribociclib plus hormone therapy for 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
This study will try to see if adding ribociclib to standard adjuvant hormone therapy is effective and safe for adults in Saudi Arabia with HR+/HER2- early breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 177 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 2 sites (Riyadh and 1 other locations) |
| Trial ID | NCT06797531 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-interventional, single-arm observational study enrolling about 177 patients across selected sites in Saudi Arabia. Patients who have started ribociclib plus adjuvant endocrine therapy within the prior six months will be followed during routine care for 36 months with data captured at baseline, 3, 6, 12, 24, and 36 months. Effectiveness, safety, patient-reported outcomes, and health-care resource use will be collected from electronic medical records and eCRFs. Site investigators will invite eligible patients whose treating physicians independently decided to prescribe ribociclib.
Who should consider this trial
Good fit: Adults (≥18) in Saudi Arabia with HR+/HER2- early breast cancer (AJCC stage IIA subset/IIB/III) who have started ribociclib with adjuvant endocrine therapy within the past six months and can provide informed consent.
Not a fit: Patients who previously received another CDK4/6 inhibitor, are receiving ribociclib outside the adjuvant setting, are enrolled in other clinical trials, or cannot give consent are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could support that ribociclib plus endocrine therapy is effective and safe for HR+/HER2- early breast cancer patients in routine care in Saudi Arabia.
How similar studies have performed: Randomized trials of adjuvant ribociclib have reported promising efficacy signals, but real-world observational data in specific populations like Saudi Arabia remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Riyadh and 1 other locations
- Novartis Investigative Site — Riyadh, Saudi Arabia (Recruiting)
- Novartis Investigative Site — Riyadh, Saudi Arabia (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.