Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Retrospective, multicentered, observational study
Study drug and medical condition

Medical condition to be studied

Breast cancer metastatic

Additional medical condition(s)

Disease characteristics when starting treatment: breast cancer,stage (locally advanced, metastatic), appearance of advanced disease (de novo,,recurrent), metastases location (visceral, bone only),Comorbidities –Ischemic heart disease, heart failure, depression, cerebrovascular,disease, diabetes, osteoporosis, hypothyroidism and others
Population studied

Short description of the study population

The study population involved female patients with metastatic breast cancer aged 18 years or older identified between 01 January 2019 and 31 December 2020.
Inclusion criteria:
1. Being a Turkish citizen
2. Being older than 18 year-old women
3. Hormone positive (>1% hormone positive) and human epidermal growth factor receptor 2 negative patients
4. Patients that treated with specified dose in the below:
i) Patients with first-line (1L) mBC treatment whose treatment duration started in January 2019 - December 2020.
ii) Patients with second-line (2L) mBC treatment duration started in January 2019-December 2020.
iii) Patients with third-line (3L) mBC treatment duration started in January 2019-December 2020.
5. Patients with locally advanced or metastatic disease who are not suitable for curative treatment.

Exclusion criteria:
1. Patients meeting any of the following criteria will not be included in the study:
i) Patients without treatment information from previous lines (only for the second line and third line treated patients),
ii) HER2 positive patients’ data will be excluded from the study.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
Other

Special population of interest, other

Metastatic breast cancer patients

Estimated number of subjects

1000
Study design details

Main study objective

To describe patient demographics, clinical and disease characteristics and treatment patterns of Hormone-receptor positive HR (+) HER2 (-) locally advanced and metastatic breast cancer (mBC) women treated in the routine practice setting in Turkey.

Outcomes

To determine rate of chemotherapy and endocrine therapy for HR (+) HER2 (-) metastatic breast cancer patients. To evaluate the responses to treatments (chemotherapy and endocrine therapy) used in routine clinical practice in patients with mBC in Turkey Demographics of treated all HR+ HER2- mBC patients To determine the treatment pattern: dose reduction rate To determine the disease characteristics when starting treatment: breast cancer stage (locally advanced, metastatic), appearance of advanced disease

Data analysis plan

Descriptive statistics will be used for continuous variables. Variables that met the normal distribution will be considered as mean and standard deviation, ordinal variables or variables that do not met the normal distribution will be evaluated as medians and ranges, categorical variables will be evaluated as numbers and percentages. Survival analysis will be performed using the Kaplan-Meier estimator for univariate analysis and the Log-rank test for in-group comparisons. For all comparisons, p <0.05 will be considered for statistical significance. Statistical Package for Social Sciences (SPSS) 19.0 for Windows program will be used for data analysis.