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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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/exclusion criteria may apply.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Novartis
Basel
Switzerland
More Novartis Pharmaceuticals trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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