Clinical trial NCT06619704: Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: 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.


Eligibility criteria: 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.

* Treated with ribociclib plus letrozole relapsed after 12 months completing adjuvant treatment or without any prior endocrine treatment for metastatic disease, 1 line or less chemotherapy was allowed.
* Treated with ribociclib plus fulvestrant, clinical and/or radiological disease progression after at least 6 months and at least 1 aromatase inhibitor treatment for metastatic disease or relapsed after 12 months adjuvant aromatase inhibitor treatment and/or relapsed within 12 months completing adjuvant aromatase inhibitor, 2 lines or less prior treatments and 1 line or less prior chemotherapy at metastatic setting were allowed.
* Had first treatment response rate assessment within 6 months after ribociclib initiation.
* Initiated ribociclib in combination with letrozole/fulvestrant after MBC diagnosis after local approval of ribociclib in June 2020.

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:

* Pre- or perimenopausal women.
* Enrollment in an interventional clinical trial for MBC during the study observation period.
* Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
* Evidence of another primary cancer within 3 years prior to the initial line containing ribociclib.

Primary outcomes:
measure: Overall Response Rate (ORR) at First Assessment After Initiation of Treatment Combinations
timeFrame: Up to 6 months
Secondary outcomes:
measure: Number of Patients Categorized by Former Treatment
timeFrame: Baseline
measure: Number of Patients who Used Chemotherapy per Treatment Combination
timeFrame: Up to 3 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 3 years
measure: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Time to Progression
timeFrame: Up to 3 years
measure: Time to Chemotherapy Post-ribociclib Plus Letrozole or Fulvestrant Treatments
timeFrame: Up to 3 years
measure: Duration of Treatment
timeFrame: Up to 3 years
measure: Proportion of Patients With Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)/Progressive Disease (PD)
timeFrame: Up to 6 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: