Real-World Data on Clinical Characteristics, Demographics, and Outcomes of Patients With Metastatic Breast Cancer in Turkey

Demographic Data and Outcomes Of Metastatic Breast Cancer Patients Treated Over The Last Decade At Tertiary Oncology Clinics In Highly Populated Cities In Turkey: A Turkish Oncology Collaborative Group Analysis

This study is planned as a secondary data use (SDU) study and the data collection will be performed retrospectively. Patients who presented to the participating sites with metastatic breast cancer will be defined, and patients' data will be recorded into a database.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer

Detailed Description

This study is planned as a secondary data use (SDU) study and the data collection will be performed retrospectively. Patients who presented to the participating sites with metastatic breast cancer will be defined and patients' data will be recorded into a database. The study will be performed at clinical centers located in the populated cities with high clinical and diagnostic standards including patients presented with metastatic disease will be recorded. It is also planned to collect data on the treatment of metastatic breast cancer in line with institutional guidelines at academic and private centers which has implemented high quality clinical and pathologic standards.

This retrospective study is designed to record, define and evaluate the changes in the presentation patterns, pathological subtypes and outcomes of metastatic breast cancer patients in relation with the evolution of overall and progression-free survival rates following the changes in treatment approaches over the last decade based on the evolving/different treatment regimens of metastatic breast cancer.

These findings will shed light on how changes in metastatic patterns have influenced practice patterns, as well as the generalizability of this data to the current knowledge and physician's adherence to adopt contemporary treatment options which have been integrated within standard treatment algorithms.

Demographic characteristics of metastatic breast cancer patients, diagnosis of disease and treatments initiated for all patients receiving first line (1L) and second line (2L) treatment who were admitted to the clinical centers starting from year 2010 will be retrospectively collected for this study. Data of patients who previously consented for institutional data sharing will be retrieved from patient charts and recorded in a secure electronic registry.

The study data will be categorized on two different patient characteristics: Metastatic pattern at presentation [recurrent metastatic breast cancer (rMBC) or de-novo metastatic breast cancer (dnMBC)] of patient and date of initial presentation for diagnosis and treatment. The study is planning to analyze patients with follow-up data of minimum 3 years and the data recording will eventually plan to construct two cohorts based on the initial diagnosis date; patient diagnosed during Jan 2010-Dec 2014 and Jan 2015-Dec 2019.

The main goal of the study is to define whether if any changes in the treatment practices occurred during the period of data record in line changes occurred with the availability of novel diagnostic methods and treatments for metastatic breast cancer.

• Study Type: Observational
• Enrollment (Actual): 1331

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University Hospital
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Istanbul University
  • Maslak
    • Istanbul, Maslak, Turkey, 34457
      • Acibadem Maslak Hospital
  • Pendik
    • Istanbul, Pendik, Turkey, 34899
      • Marmara University Pendik Training and Research Hospital
  • Üsküdar
    • Istanbul, Üsküdar, Turkey, 34662
      • Acibadem Altunizade Hospital, Istanbul
  • Şişli
    • Istanbul, Şişli, Turkey, 34365
      • American Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with metastatic breast cancer during January 2010-December 2014 and January 2015-December 2019 who were previously treated at the selected/participating clinical centers.

Description

Inclusion Criteria:

• Age ≥ 18 years, no upper age limit.
• Must have a definite diagnosis of metastatic breast cancer at the time of initial application at any of the participating clinical centers.
• Patients who were initiated their first treatment at the center where the initial mBC diagnosis was made and whose follow-up and treatment period have continued at the current center.
• Patients must have signed an informed consent that allow collection of personal data and protection of patient confidentiality according to the standard procedures of each participating center.

Exclusion Criteria:

• Patients who were referred to the participating centers for further treatment for a second opinion.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Time period 2010-2014; Data from Turkish participants with metastatic breast cancer diagnosed January 2010-December 2014 will be retrospectively collected.
Time period 2015-2019; Data from Turkish participants with metastatic breast cancer diagnosed January 2015-December 2019 will be retrospectively collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment outcome data: Overall survival (OS)	OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause. OS data: number (%) patients receiving first-line, second-line, third-line chemotherapy	Up to 10 years
Treatment outcome data: Progression-free survival (PFS)	PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. PFS data: number (%) patients receiving first-line, second-line, third-line chemotherapy	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression (TTP)	Time to progression is measured as the time from study entry to the development of disease progression.	Up to 10 years
Demographic characteristics at baseline	Patient demographics: age and gender.; Type of insurance (social security system, private insurance) [if available]	Up to 10 years
Clinical and pathological characteristics: Diagnosis	Date and stage of diagnosis	Up to 10 years
Clinical and pathological characteristics: Clinical and/or pathological stage	Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system	Up to 10 years
Clinical and pathological characteristics: Lymph nodes	Number (N) of lymph nodes involved / retrieved	Up to 10 years
Clinical and pathological characteristics: Tumor size	Measured by a pathologist from the tumor surgical specimen at breast surgery [unifocal, multifocal, multicentric]	Up to 10 years
Clinical and pathological characteristics: Pathological subtype	Number of patients with different pathological subtypes [HER2+/HR- , HER2+/HR+, HER2-/HR+, TNBC]	Up to 10 years
Clinical and pathological characteristics: Hormone-receptor expression	Estrogen Receptor positivity [%] Progesterone Receptor positivity [%]	Up to 10 years
Clinical and pathological characteristics: Human Epidermal Growth Factor Receptor 2 (HER-2) expression	HER2 status will be determined by immunohistochemistry (IHC) [scoring: 0, 1+, 2+, 3+] In situ hybridization (ISH) will be used to confirm IHC results [positive/negative and amplification ratio (%)] Progesteron Receptor positivity [%]	Up to 10 years
Clinical and pathological characteristics: Histological type	Histological type: Invasive ductal, invasive lobular, other.	Up to 10 years
Clinical and pathological characteristics: Histological grade	Histological grade with using Modified Bloom Richardson grading system: Grade 1, Grade 2, Grade 3	Up to 10 years
Clinical and pathological characteristics: Nuclear grade	Nuclear grade: Grade 1, Grade 2, Grade 3	Up to 10 years
Anatomopathological characteristics of the tumor: Ki-67	Tumor Ki-67 proliferation index will be collected	Up to 10 years
Treatment data: type of chemotherapy	Number (%) patients receiving neoadjuvant or adjuvant chemotherapy	Up to 10 years
Treatment data: adjuvant hormonotherapy	Number (%) patients receiving adjuvant hormonotherapy	Up to 10 years
Treatment data: radiotherapy	Number (%) patients receiving radiotherapy [Stereotactic Body Radiation Therapy (SBRT), conventional radiotherapy or other]	Up to 10 years
Treatment data: surgery	Number (%) patients underwent surgery [by regions]	Up to 10 years
Treatment data: locally ablative treatment	Number (%) patients had locally ablative treatment [by regions]	Up to 10 years
Follow-up data: initial recurrence	Date and site of recurrence [visceral, non-visceral, central nervous system (CNS) and oligometastatic]	Up to 10 years
Follow-up data: current condition	The date of the last review and current clinical condition will be recorded.	Up to 10 years
Follow-up data: date and cause of death	Date and cause of death, when applicable.	Up to 10 years

Collaborators and Investigators

• Sponsor: Turkish Oncology Group
• Collaborators: Istanbul University; Marmara University Pendik Training and Research Hospital; V.K.V. American Hospital, Istanbul; Hacettepe University, Faculty of Medicine; Acibadem Maslak Hospital; Ege University Hospital; Acibadem Altunizade Hospital, Istanbul

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ML42450

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No