A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Br… (NCT06075758) | Clinical Trial Compass
CompletedNot Applicable
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
Jordan, Oman, United Arab Emirates175 participantsStarted 2024-03-07
Plain-language 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-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.