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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ribociclib

Treatment groups

177 Participants
are divided into 1 treatment group

Sponsors and collaborators