NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06797531

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: HR+/HER2- Early Breast Cancer

Interventions: ribociclib

Countries: Saudi Arabia

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (2)

Riyadh, Saudi Arabia
Riyadh, Saudi Arabia