NCT06797531 RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
| NCT ID | NCT06797531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | HR+/HER2- Early Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 177 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 177 participants in total. It began in 2025-08-27 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06797531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying HR+/HER2- Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06797531 currently recruiting?
Yes, NCT06797531 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06797531 trial being conducted?
This trial is being conducted at Riyadh, Saudi Arabia, Riyadh, Saudi Arabia.
Who is sponsoring the NCT06797531 clinical trial?
NCT06797531 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 177 participants.
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