Actively Recruiting
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
Led by Novartis Pharmaceuticals · Updated on 2026-02-04
177
Participants Needed
2
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated Patient Informed Consent Form (PICF) obtained.
- Age 18 years or older at the time of consent.
- Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive breast cancer.
- Male or female patients with HER2-negative breast cancer.
- Currently receiving ribociclib combined with adjuvant endocrine therapy for up to 6 months prior to enrollment.
- Diagnosed with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA (subset), IIB, or III early breast cancer.
- Female patients with known menopausal status at consent or initiation of adjuvant endocrine therapy, or male patients.
You will not qualify if you...
- Receiving ribociclib-based treatment beyond adjuvant therapy for early breast cancer.
- Currently participating in any other clinical trials.
- Previously treated with any other CDK4/6 inhibitor.
- Refused to sign informed consent.
- Considered by the investigator unlikely to provide accurate medical history or long-term follow-up information.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
2
Novartis Investigative Site
Riyadh, Saudi Arabia, 11426
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here