Status:
RECRUITING
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18-100 years
Brief Summary
This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-...
Detailed Description
The investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. Retrospective patients should have been on Ribociclib in combination...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
- Advanced /metastatic breast cancer
- Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
- HER2-negative breast cancer.
- Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
- For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit.
- For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment
- For ambispective part, patients agree to sign informed consent before their enrollment.
Exclusion
- Ribociclib-based treatment regimen beyond the second line.
- Patients are currently participating in any other clinical trials.
- Patient with a known hypersensitivity to any of the excipients of Ribociclib.
- Patients who previously received any other CDK4/6 inhibitor .
- For ambispective patients, patients who refuse to sign the informed consent
Key Trial Info
Start Date :
March 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06075758
Start Date
March 7 2024
End Date
June 30 2025
Last Update
January 14 2025
Active Locations (4)
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1
Novartis Investigative Site
Amman, Jordan, 11941
2
Novartis Investigative Site
Muscat, Oman, 1331
3
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
4
Novartis Investigative Site
Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates