Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy

N/ACompletedNCT06619704

Novartis Pharmaceuticals194 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

194

Conditions

Metastatic Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall Response Rate (ORR) at First Assessment After Initiation of Treatment Combinations

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: Up to 6 months

Secondary Outcomes

Number of Patients Categorized by Former Treatment

Time frame: Baseline

Number of Patients who Used Chemotherapy per Treatment Combination

Treatment combinations included ribociclib plus letrozole and ribociclib plus fulvestrant.

Time frame: Up to 3 years

Progression Free Survival (PFS)

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

Overall Survival (OS)

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 to Progression

Time frame: Up to 3 years

Time to Chemotherapy Post-ribociclib Plus Letrozole or Fulvestrant Treatments

Time frame: Up to 3 years

Duration of Treatment

Time frame: Up to 3 years

Proportion of Patients With Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)/Progressive Disease (PD)

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 (CBR)

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.

Time frame: Up to 6 months

Observational Retrospective Study to Assess the Use of Ribociclib in Patients With HR+, HER2- Metastatic Breast Cancer Treated With Chemotherapy

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes