Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, HR-Positive, HER2-Negative, Real-world data, Observational Study, Treatment Patterns, China
Brief summary
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer patients in China; and exploratory describe clinical outcomes by treatment regimens, also report the QoL and other patient-report outcomes (PRO) and to assess healthcare resource utilization (HCRU) and costs overall and by LoT.
Detailed description
The study consists of both retrospective and prospective components, defined relative to the index date.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\* Must be competent and able to comprehend, sign, and date an Institutional Review Board or Institutional Ethics Committee approved Informed consent form (ICF) before participating in the study. OR Eligible for exemption from informed consent (for patients who die or became lost to follow-up within 2 months of initiating 2L therapy). \* Chinese men or women ≥ 18 years old at time of consent. \* Pathologically documented breast cancer that: a) is unresectable or metastatic. b) is HR+/HER2- (IHC 2+/ISH- or IHC 1+ or IHC 0, with/without membrane staining) based on the most recent test result \* Planning to initiate 2L treatment or initiated 2L systemic therapy within 2 months prior enrollment as per the prescription or medical records.
Exclusion criteria
\* Patients who plan to participate in any blinded interventional clinical trial in 2L setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients receiving different regimens in each Line of treatment (LoT) | From baseline up to 5 years | Percentage of participants receiving each systemic regimen within a given LoT. |
| Percentage of participants receiving different treatment sequence across LoTs | From baseline up to 5 years | Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT. |
| The attrition rate after each Line of Treatment (LoT) | From baseline up to 5 years | Among participants with a documented therapy end for a given LoT, the percentage who did not initiate the next LoT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker and Genetic Testing Pattern | From baseline up to 5 years | Metrics include percentage of participants who undergo testing per biomarker/mutation within each LoT, testing timing, specimen type, assay method, and result distribution. |
| Demographic characteristics | At baseline | Metrics include descriptive statistics for age and counts for categorical variables |
| Percentage of Participants with AEs, TRAEs, and SAEs | From baseline up to 5 years | Proportion of participants with AEs, TRAEs, and SAEs, by MedDRA SOC/PT and CTCAE v6.0 grade; proportions with AEs leading to dose modification, discontinuation, or death. Includes suspected drug, AE dates, seriousness, causality, and outcomes. |
| Clinical management of adverse events of special interest | From baseline up to 5 years | Metrics include percentage of participants who underwent diagnostic tests, prophylactic medications, therapeutic medications, dose modifications of treatment regimens, and follow-up assessments. |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | At baseline | Percentage of participants with different ECOG PS |
| ER/PR status | At baseline | Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status |
| HER2 status | At baseline | Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status |
| TNM stage at diagnosis | At baseline | Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis |
| Endocrine resistance | At baseline | Percentage of participants with different endocrine resistance status |
Countries
China
Contacts
CONTACTAstra Zeneca Clinical Study Information Center
Outcome results
None listed