Breast Cancer
Conditions
Keywords
Ribociclib, CDK4/6 inhibitor, Metastatic breast cancer, HR+/HER2-, Real-world evidence, Treatment patterns, Dose modification, Tolerability, Older adults, African American
Brief summary
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. Included in Flatiron's mBC Enhanced Data Model (EDM): 1. Had an International Classification of Diseases (ICD) diagnosis of breast cancer (ICD, 9th revision, clinical modification \[ICD-9-CM\] 174.x or 175.x or ICD, 10th revision, clinical modification \[ICD-10-CM\] C50x) 2. At least two documented clinical visits, on different days, occurring on or after January 1, 2011 3. Included in probabilistic sample of patients queued for review via abstraction 4. Had pathology consistent with breast cancer 5. Had evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011, including patients diagnosed as stage IV at initial diagnosis, or diagnosed with earlier stage disease who then developed metastatic disease 2. Initiated treatment with first-line (1L) ribociclib (in combination with endocrine therapy \[ET\]) in the metastatic setting on or after January 1, 2018, and at least 6 months prior to the study data cutoff date (October 31, 2024) to ensure adequate time to observe dose modifications and treatment discontinuations 3. Had evidence of HR+/HER2- test result prior to or up to 30 days after initiation of 1L ribociclib 4. Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024
Exclusion criteria
1. Use of any CDK4/6 inhibitor therapy in combination with tamoxifen 2. Use of any CDK4/6 inhibitor in the pre-metastatic setting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Baseline | Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure. |
| Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Baseline | — |
| Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Baseline | — |
| Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Status Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older, | Baseline | ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased). |
| Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Baseline | — |
| Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Up to approximately 6 years, 10 months | — |
| Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Up to approximately 6 years, 10 months | Dose modifications defined as a dose being held, increased, or decreased. |
| Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Up to approximately 6 years, 10 months | Dose modifications defined as a dose being held, increased, or decreased. |
| Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Up to approximately 6 years, 10 months | — |
| Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older | Up to approximately 6 years, 10 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Black/African American Patients | Baseline | Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure. |
| Age at 1L Ribociclib Initiation Among Black/African American Patients | Baseline | — |
| BMI at 1L Ribociclib Initiation Among Black/African American Patients | Baseline | — |
| Number of Patients by ECOG Performance Status Among Black/African American Patients | Baseline | ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased). |
| Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Black/African American Patients | Baseline | — |
| Number of Patients by Initial and Subsequent Dosing Among Black/African American Patients | Up to approximately 6 years, 10 months | — |
| Number of Patients With Dose Modifications Among Black/African American Patients | Up to approximately 6 years, 10 months | Dose modifications defined as a dose being held, increased, or decreased. |
| Number of Patients by Reasons for Dose Modifications Among Black/African American Patients | Up to approximately 6 years, 10 months | Dose modifications defined as a dose being held, increased, or decreased. |
| Number of Patients Who Discontinued Treatment Among Black/African American Patients | Up to approximately 6 years, 10 months | — |
| Number of Patients by Reason for Treatment Discontinuation Among Black/African American Patients | Up to approximately 6 years, 10 months | — |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed