Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
NCT Number: NCT06619704
EILEEN was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in Turkey. Group I cohort of the study was based on secondary use of data of postmenopausal hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients treated with ribociclib in combination with letrozole (LET) or fulvestrant (FUL) after June 2020. Group II cohort of the study was a parallel, comprehensive chart review for detecting all postmenopausal HR+, HER2- MBC patients who were eligible for cyclin-dependent kinase inhibitors (CDKis) but received chemotherapy. The study used secondary data which was retrieved from electronic or paper medical records or clinical databases available at the sites. Regular follow up with close monitorization was used for the effective management of patients with breast cancer. Data sources included information about diagnosis, treatment and monitorization of patients at an individual level. The study used medical patient records at hospitals e.g. hospital discharge files, primary clinical records and electronic medical records.
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Female
Observational
East Hanover, New Jersey, 07936, United States
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group I: Postmenopausal female patients who had histologically or cytologically confirmed HR-positive (10% or more ER+), HER2-negative, metastatic breast cancer and initiated ribociclib combinations per local label.
Group II: Postmenopausal female patients who had histologically or cytologically confirmed HR-positive (10% or more ER+), HER2-negative, metastatic breast cancer eligible for cyclin-dependent kinase (CDK) inhibitors according to local label but started chemotherapy.
Exclusion criteria
Time frame: Up to 6 months
Treatment combinations included ribociclib plus letrozole and ribociclib plus fulvestrant.
ORR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1.
Time frame: Baseline
Time frame: Up to 3 years
Treatment combinations included ribociclib plus letrozole and ribociclib plus fulvestrant.
Time frame: Up to 3 years
PFS was defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment.
Time frame: Up to 3 years
OS was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient was alive.
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 6 months
CR was defined as the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have had a reduction in short axis to less than 10 mm.
PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
SD was defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.
PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm.
Time frame: Up to 6 months
Clinical benefit rate: ORR and as defined by RECIST 1.1. CBR was defined as percentage of patients with complete response (CR), partial response (PR) per RECIST or stable disease (SD) lasting 24 weeks or longer.
Novartis Pharmaceuticals
Industry
A rEtrospectIve Real-world Analysis of earLy responsE ratEs With Ribociclib and Endocrine Therapy and Descriptive aNalysis of HR+, HER2- Metastatic Breast Cancer Patients Treated With Chemotherapy (EILEEN)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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