Breast Cancer
Conditions
Keywords
Early Breast Cancer, HR+/HER2-
Brief summary
The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) patients. This is a multi-country study using secondary real-world data sources.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Evidence of diagnosis of eBC during the identification period. 2. Aged ≥18 years at index diagnosis date. The index diagnosis date is the date of first diagnosis of eBC. 3. Anatomic stage I-III breast cancer (BC) per American Joint Committee on Cancer (AJCC), 8th Edition at index diagnosis date. 4. Evidence of HR+ during the study period: 1. have tested positive for estrogen receptor (ER+), or 2. have tested positive for progesterone receptor (PR+), or 3. have tested positive for both. 5. Tested negative for HER2 (HER2-) during the study period. 6. Evidence of surgical resection of the primary breast tumor at any time. 7. Received endocrine therapy (ET) in the adjuvant setting after index diagnosis date.
Exclusion criteria
1. Evidence of another secondary malignancy at any time prior to index diagnosis date. 2. Evidence of other primary cancer (except for skin cancer) at any time prior to index diagnosis date. 3. Patients who participate in an interventional clinical trial at any time prior to or during the study period. 4. Patients with severely incomplete or inconsistent data, precluding validity of results. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort B and Subcohort B1: Proportion of Patients by Baseline Demographics and Clinical Characteristics | Baseline | Baseline characteristics (subject to data availability) include: * Age group * Sex * Race/Ethnicity * Geographic region * Insurance type * Menopausal status * Body mass index (BMI) category * Alcohol use * Year of initial BC diagnosis * Tumor stage and grade * Clinical pathological node and tumor stage * Multiple breast primary diagnoses (yes/no) * Eastern Cooperative Oncology Group (ECOG) performance status * Estrogen and progesterone receptor status * HER2 immunohistochemistry (IHC) test results (0, 1+, 2+, 3+) * HER2 Fluorescence In Situ Hybridization (FISH) test (positive, negative) * Ki-67 category (positive, negative) * Genomic risk score * Hepatic dysfunction (yes/no) * Renal dysfunction (yes/no) * Cardiovascular disease (yes/no) * Gastrointestinal (GI) dysfunction (yes/no) |
| Cohort B and Subcohort B1: Proportion of Patients by Demographics and Clinical Characteristics at Index Treatment Date | Baseline | The index treatment date is the date of adjuvant ribociclib treatment initiation. Demographics and clinical characteristics (subject to data availability) include: * Age group * Insurance type * Menopausal status * BMI category * ECOG performance status |
| Cohort B and Subcohort B1: Charlson Comorbidity Index (CCI) | Baseline | CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2). |
| Cohort B and Subcohort B1: AST Levels at Index Diagnosis Date and Index Treatment Date | Baseline | Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation. |
| Cohort B and Subcohort B1: ALT Levels at Index Diagnosis Date and Index Treatment Date | Baseline | Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation. |
| Cohort B and Subcohort B1: Total Bilirubin Level at Index Diagnosis Date and Index Treatment Date | Baseline | Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation. |
| Cohort B and Subcohort B1: QTc Interval at Index Diagnosis Date and Index Treatment Date | Baseline | Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation. |
| Cohort B and Subcohort B1: Neutrophil Count at Index Diagnosis Date and Index Treatment Date | Baseline | Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation. |
| Cohort B and Subcohort B1: Duration Between Initial Diagnosis and Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Duration Between Initial Diagnosis and Surgery | Up to 40 months | — |
| Cohort B and Subcohort B1: Duration Between Surgery and Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Type of Surgery Prior to Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Type of BC Treatment Prior to Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Duration of Neoadjuvant and Adjuvant Therapy by Type, Prior to Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Year of ET Initiation, Prior to Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Duration of ET by Type, Prior to Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Duration of Other Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment by Type, Prior to Ribociclib Initiation | Up to 40 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A: Proportion of Patients by Baseline Demographics and Clinical Characteristics | Baseline | Baseline characteristics (subject to data availability) include: * Age group * Sex * Race/ethnicity * Geographic region * Insurance type * Menopausal status * BMI category * Alcohol use * Year of initial BC diagnosis * Tumor stage and grade * Clinical pathological node and tumor stage * Multiple breast primary diagnoses (yes/no) * ECOG performance status * Estrogen and progesterone receptor status * HER2 IHC test results (0, 1+, 2+, 3+) * HER2 FISH test (positive, negative) * Ki-67 category (positive, negative) * Genomic risk score * Hepatic dysfunction (yes/no) * Renal dysfunction (yes/no) * Cardiovascular disease (yes/no) * GI dysfunction (yes/no) |
| Cohort A: CCI | Baseline | CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2). |
| Cohort A: Duration Between Initial Diagnosis and Surgery | Up to 58 months | — |
| Cohort A: Proportion of Patients by Type of Surgery | Up to 58 months | — |
| Cohort A: Proportion of Patients by Type of BC Treatment Received | Up to 58 months | — |
| Cohort A: Duration of Neoadjuvant and Adjuvant Therapy by Type | Up to 58 months | — |
| Cohort A: Proportion of Patients by Year of ET Initiation | Up to 58 months | — |
| Cohort A: Duration of ET by Type | Up to 58 months | — |
| Cohort A: Duration of Other CDK4/6i Treatment by Type | Up to 58 months | — |
| Cohort A: Proportion of Patients by Type of Concomitant Medication Received | Up to 58 months | — |
| Cohort B and Subcohort B1: Proportion of Patients Who Switch to an Alternative CDK4/6i | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients Who Receive Concomitant Systemic and Local Oncology Therapies | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients Who Receive Subsequent Systemic and Local Oncology Therapies Administered After Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Duration of Subsequent Systemic and Local Oncology Therapies Administered After Ribociclib Initiation, by Type of Therapy | Up to 40 months | — |
| Cohort B and Subcohort B1: Time Between Discontinuation of Ribociclib and Start of Subsequent Systemic and Local Oncology Therapies, by Type of Therapy | Up to 40 months | — |
| Cohort B and Subcohort B1: Initial Dose of Ribociclib | Baseline | — |
| Cohort B and Subcohort B1: Proportion of Patients Who Undergo Ribociclib Dose Reduction | Up to 40 months | — |
| Cohort B and Subcohort B1: Time to First Ribociclib Dose Reduction | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Dose Reduction | Up to 40 months | — |
| Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Interruptions per Patient Prior to Ribociclib Dose Reduction | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients Who Experience Ribociclib Dose Interruption | Up to 40 months | — |
| Cohort B and Subcohort B1: Time to First Ribociclib Dose Interruption | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Dose Interruption | Up to 40 months | — |
| Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Reductions per Patient Prior to Ribociclib Dose Interruption | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients Who Discontinue Ribociclib Treatment | Up to 40 months | — |
| Cohort B and Subcohort B1: Time-to-Discontinuation (TTD) of Ribociclib Treatment | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Discontinuation | Up to 40 months | — |
| Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Interruptions per Patient Prior to Ribociclib Discontinuation | Up to 40 months | — |
| Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Reductions per Patient Prior to Ribociclib Discontinuation | Up to 40 months | — |
| Cohort B and Subcohort B1: Persistence of Ribociclib Treatment | Up to 40 months | Persistence of ribociclib treatment, defined as the proportion of days covered (PDC) from the first prescription of ribociclib to data cut-off, discontinuation, or end of treatment. |
| Cohort B and Subcohort B1: Number of Clinical Visits and/or Laboratory Assessments for Ribociclib Monitoring | Up to 40 months | — |
| Cohort B and Subcohort B1: Cumulative Exposure to Ribociclib | Up to 40 months | Cumulative exposure to ribociclib, measured as the dose of ribociclib multiplied by days received for each prescription during the treatment duration (original dose to discontinuation). |
| Subcohort B1: Incidence of Adverse Events (AEs) of Interest | Up to 6 months | AEs of interest include liver enzyme elevation, QT interval prolongation, neutropenia, fatigue, leukopenia, thrombocytopenia, anemia, infections, and interstitial lung disease/pneumonitis. |
| Subcohort B1: Proportion of Patients Requiring Changes to the Ribociclib Regimen Following AE Occurrence | Up to 6 months | Changes to ribociclib regimen include dose reduction, dose interruption, treatment discontinuation, switching to another CDK4/6i, and initiating supportive therapies. |
| Subcohort B1: Proportion of Patients by the Sequalae of AEs | Up to 6 months | Sequalae of AEs reported as follows: amelioration (improvement) of AE, progression of AE, resolution of AE, and recurrence of AE. |
| Cohort B and Subcohort B1: Proportion of Patients Undergoing Drug-drug Interaction (DDI) Assessment Upon Ribociclib Initiation | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients With Actual DDIs | Up to 40 months | Actual DDIs will be defined based on clinical manifestation, assessed based on available data in each data set. |
| Cohort B and Subcohort B1: Number of DDIs per Patient | Up to 40 months | — |
| Cohort A: Proportion of Patients With Potential DDIs | Up to 58 months | Potential DDIs will be defined as concomitant administration of ribociclib with another drug that can potentially alter the efficacy and safety of the interacting treatments. |
| Cohort B and Subcohort B1: Proportion of Patients With Potential DDIs | Up to 40 months | Potential DDIs will be defined as concomitant administration of ribociclib with another drug that can potentially alter the efficacy and safety of the interacting treatments. |
| Cohort B and Subcohort B1: Proportion of Patients With Potential DDIs Who Experience AEs | Up to 40 months | — |
| Cohort B and Subcohort B1: Proportion of Patients by Clinical Monitoring Practices Before and After DDI Occurrence | Up to 40 months | — |
| Cohort B and Subcohort B1: Among Patients With Clinically Consequential DDIs, Number of Patients by Demographics and Clinical Characteristics | Up to 40 months | Demographics and clinical characteristics include * Age group * Sex * Race/ethnicity * Geographic region * Insurance type * Menopausal status * BMI category * Alcohol use * Year of initial BC diagnosis * Tumor stage and grade * Clinical pathological node and tumor stage * Multiple breast primary diagnoses (yes/no) * ECOG performance status * Estrogen and progesterone receptor status * HER2 IHC test results (0, 1+, 2+, 3+) * HER2 FISH test (positive, negative) * Ki-67 category (positive, negative) * Genomic risk score * Hepatic dysfunction (yes/no) * Renal dysfunction (yes/no) * Cardiovascular disease (yes/no) * GI dysfunction (yes/no) |
| Cohort B and Subcohort B1: Among Patients With Clinically Consequential DDIs, Number of Patients by BC Treatment Prior to Ribociclib | Up to 40 months | — |
| Cohort B and Subcohort B1: Frequency of Ribociclib Treatment Modifications Related to DDIs | Up to 40 months | Treatment modifications include dose adjustments, interruptions, reductions, discontinuations, and switches to other therapies. |
Countries
Switzerland
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed