HR+/HER2- Advanced or Metastatic Breast Cancer
Conditions
Keywords
HR+/HER2- advanced or metastatic breast cancer, China,, NIS
Brief summary
This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of sufficient evidence for ribociclib as a most recently marketed drug in the real-world setting.
Detailed description
This study is a longitudinal, non-interventional, retrospective, and observational study based on secondary real-world data in the National Anti-Tumor Drug Surveillance System (NATDSS) database. The study will not involve any active intervention, randomization, or control group. All analyses will be conducted using Electronic Health Record (EHR) routinely collected in clinical practice and additional secondary data sources
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with HR+/HER2- ABC: HR+ is defined as ER+ or PR+, and HER2+ is defined as immunohistochemistry 3+, or 2+ with positive in situ hybridization (amplification). Advanced or metastatic breast cancer is defined as having a documented inoperable clinical or pathological stage IIIB, IIIC, or IV, or the records indicating distant metastasis. 2. Initiation of 1L anti-cancer treatment between Jan. 1, 2024 and Jan. 1, 2027; Defined as having records of systemic anti-cancer treatment in disease course records or order records within 90 days after the initial diagnosis of ABC, and receiving the first dose between Jan. 1, 2024 and Jan. 1, 2027, as recorded in the NATDSS database. 3. Aged 18 years or older at the time of receiving the 1L treatment; Definition: The initiation date (index date) of 1L treatment is defined as the initiation date of systemic anti-cancer treatment for HR+/HER2- ABC first recorded in the database. Age will be preferentially calculated based on the date of birth (or year of birth) and the initiation date of 1L treatment in the database. If the birth information is not included in the database but shown in an "Age" field in the medical visit/hospitalization record associated with 1L treatment, this age field will be used as the basis for age. 4. At least 3 months of follow-up records after the initiation of 1L treatment. Defined as having at least one outpatient or inpatient medical visit record in the NATDSS at least 3 months after the index date.
Exclusion criteria
(1) Patients with any other concomitant invasive malignancies Defined as patients meeting any of the following conditions based on their diagnosis records in the cancer registry/medical database used for the study: 1. Within 5 years before the diagnosis of HR+/HER2- ABC, there is a diagnosis record of invasive malignancy other than breast cancer in the database (based on the International Classification of Diseases \[ICD\] diagnosis code or cancer registry code), and the diagnosis is not carcinoma in situ or benign/borderline tumor; 2. On the day of, or within 3 months after, the diagnosis of HR+/HER2- ABC, there is a new diagnosis record of invasive malignancy at another site (also based on the ICD diagnosis code or cancer registry code) indicating a concomitant active malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of first-line treatment regimens | Up to 39 months | Proportion of patients receiving each first line treatment category and specific regimen |
| Proportion of patients with treatment changes | Up to 39 months | Proportion of patients who discontinue or switch first line treatment |
| Time to treatment initiation, time to discontinuation, and time to next line therapy | Up to 39 months | Time to treatment initiation (TTI), time to discontinuation (TTD), and time to next-line therapy (TTNT) |
| Proportion of patients by initial CDK4 6 inhibitor dose | Up to 39 months | Proportion of patients treated with a CDK4 6 inhibitor, stratified by initial dose level |
| Proportion of patients with dose modifications of CDK4/6 inhibitor therapy | Up to 39 months | Proportion of patients treated with CDK4/6 inhibitor who experience any dose modification (including dose reduction and interruption) |
| Time to first dose modification of CDK4/6 inhibitor therapy | Up to 39 months | Time from initiation of CDK4/6 inhibitor therapy to the first dose modification, including dose reduction or interruption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rwPFS of 1L treatment patterns | Up to 39 months | rwPFS is defined as the duration from the initiation date of 1L treatment to documented disease progression or death from any cause. If a patient has not experienced disease progression or death, the last confirmed survival time will be used as the censoring time to calculate the rwPFS censoring duration |
| rwPFS of HR+/HER2- ABC patients | Up to 39 months | rwPFS of HR+/HER2- ABC patients adhering or not adhering to the highest level of first-line treatment recommendation in the guidelines in the real-world setting based on the NATDSS database |
| rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens | Up to 39 months | rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens in the real-world setting based on the NATDSS database |
| Number of subjects with AESIs | Up to 39 months | AESIs under different treatment patterns, including: * Hematology: neutropenia, leukopenia, anemia, and thrombocytopenia; * Gastrointestinal tract: diarrhea, nausea, vomiting, stomatitis/mucositis; * QTc prolongation; * Hepatotoxicity: alanine transaminase (ALT)/aspartate transaminase (AST) increased, and total bilirubin increased. |
| Baseline demographics | Baseline | — |
Countries
China
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed