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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770129
• Other study ID #: ML42450
• Status: Completed
• Start date: March 22, 2021
• Est. completion date: August 8, 2022

Study information

• Verified date: January 2023
• Source: Turkish Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1331
• Est. completion date: August 8, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Turkey	Acibadem Altunizade Hospital, Istanbul	Istanbul	Üsküdar
Turkey	Acibadem Maslak Hospital	Istanbul	Maslak
Turkey	American Hospital	Istanbul	Sisli
Turkey	Istanbul University	Istanbul	Fatih
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul	Pendik
Turkey	Ege University Hospital	Izmir	Bornova

Sponsors (8)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Demographic characteristics at baseline	Patient demographics: age and gender.; Type of insurance (social security system, private insurance) [if available]	Up to 10 years
Secondary	Clinical and pathological characteristics: Diagnosis	Date and stage of diagnosis	Up to 10 years
Secondary	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
Secondary	Clinical and pathological characteristics: Lymph nodes	Number (N) of lymph nodes involved / retrieved	Up to 10 years
Secondary	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
Secondary	Clinical and pathological characteristics: Pathological subtype	Number of patients with different pathological subtypes [HER2+/HR- , HER2+/HR+, HER2-/HR+, TNBC]	Up to 10 years
Secondary	Clinical and pathological characteristics: Hormone-receptor expression	Estrogen Receptor positivity [%] Progesterone Receptor positivity [%]	Up to 10 years
Secondary	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
Secondary	Clinical and pathological characteristics: Histological type	Histological type: Invasive ductal, invasive lobular, other.	Up to 10 years
Secondary	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
Secondary	Clinical and pathological characteristics: Nuclear grade	Nuclear grade: Grade 1, Grade 2, Grade 3	Up to 10 years
Secondary	Anatomopathological characteristics of the tumor: Ki-67	Tumor Ki-67 proliferation index will be collected	Up to 10 years
Secondary	Treatment data: type of chemotherapy	Number (%) patients receiving neoadjuvant or adjuvant chemotherapy	Up to 10 years
Secondary	Treatment data: adjuvant hormonotherapy	Number (%) patients receiving adjuvant hormonotherapy	Up to 10 years
Secondary	Treatment data: radiotherapy	Number (%) patients receiving radiotherapy [Stereotactic Body Radiation Therapy (SBRT), conventional radiotherapy or other]	Up to 10 years
Secondary	Treatment data: surgery	Number (%) patients underwent surgery [by regions]	Up to 10 years
Secondary	Treatment data: locally ablative treatment	Number (%) patients had locally ablative treatment [by regions]	Up to 10 years
Secondary	Follow-up data: initial recurrence	Date and site of recurrence [visceral, non-visceral, central nervous system (CNS) and oligometastatic]	Up to 10 years
Secondary	Follow-up data: current condition	The date of the last review and current clinical condition will be recorded.	Up to 10 years
Secondary	Follow-up data: date and cause of death	Date and cause of death, when applicable.	Up to 10 years