Ribociclib plus hormone therapy for HR+/HER2- early breast cancer in Saudi Arabia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.