RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Recruiting now

Conditions studied: HR+/HER2- Early Breast Cancer

In brief

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.

Key facts

Study ID

NCT06797531

Run by

Novartis Pharmaceuticals

People needed

177

Starts

2025-08-27

Expected to finish

2028-11-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated Patient Informed Consent Form (PICF) obtained.
• The patient is ≥ 18 years-old at the time of PICF signature.
• Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
• Male or female patients with HER2- BC.
• 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.
• Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) /IIB or Anatomic Stage Group III EBC.
• Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male.

You may not qualify if…

• Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
• Patients are currently participating in any other clinical trials.
• Patients who previously received any other CDK4/6 inhibitor.
• Patients who refused to sign informed consent.
• 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 it is running

• Novartis Investigative Site — Riyadh, Saudi Arabia (enrolling)
• Novartis Investigative Site — Riyadh, Saudi Arabia (enrolling)

Full record on ClinicalTrials.gov

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