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Trial Title:
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
NCT ID:
NCT06075758
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR+/HER2- advanced/metastatic breast cancer
NIS
Ribociclib
Middle eastern countries
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
ribociclib
Description:
There is no treatment allocation for NIS trials, patients on administered ribociclib by
prescription will be enrolled.
Treatment plan represents the prescription.
Arm group label:
ribociclib ambispective
Arm group label:
ribociclib retrospective
Other name:
CLEE011
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.
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 with hormonal therapy for at least 18 months and stopped the
medication before the patient's recruitment.
Ambispective patients should have initiated Ribociclib, in combination with hormonal
therapy, for at least 12 months before the patient's recruitment date and are still on
Ribociclib in combination with hormonal therapy at recruitment. These patients will be
followed up till progression, death, Ribociclib discontinuation due to adverse events, or
till a maximum period of 6 months, whichever comes first.
Data will be collected from patient electronic medical records in the sites chosen for
patients who received Ribociclib, in combination with hormonal therapy, in the first or
second-line setting available in the relevant institutions.
A total of 550 patients is planned for this study. The planned sample size should capture
very common adverse events reported in previous studies as well as adverse events ≥ 10%
occurring in grade 3 and grade 4 with precision ±2.5%.
Criteria for eligibility:
Study pop:
HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in
combination with hormonal therapy in pre-and postmenopausal women or men in Middle
Eastern countries
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination
with hormonal therapy.
2. Advanced /metastatic breast cancer
3. Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
4. HER2-negative breast cancer.
5. Patients who received or currently receiving Ribociclib in combination with hormonal
therapy in the first or second-line settings as per the routine practice.
6. 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.
7. 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
8. For ambispective part, patients agree to sign informed consent before their
enrollment.
Exclusion Criteria:
1. Ribociclib-based treatment regimen beyond the second line.
2. Patients are currently participating in any other clinical trials.
3. Patient with a known hypersensitivity to any of the excipients of Ribociclib.
4. Patients who previously received any other CDK4/6 inhibitor .
5. For ambispective patients, patients who refuse to sign the informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Amman
Zip:
11941
Country:
Jordan
Status:
Recruiting
Start date:
March 7, 2024
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075758
