Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas
NCT07693985
Adherence Interventions, Behavior
Valencia, Spain
View Trial DetailsNCT Number: NCT04770129
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Ege University Hospital, Izmir, Bornova, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 10 years
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
Time frame: Up to 10 years
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
Time frame: Up to 10 years
Time to progression is measured as the time from study entry to the development of disease progression.
Time frame: Up to 10 years
Time frame: Up to 10 years
Date and stage of diagnosis
Time frame: Up to 10 years
Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system
Time frame: Up to 10 years
Number (N) of lymph nodes involved / retrieved
Time frame: Up to 10 years
Measured by a pathologist from the tumor surgical specimen at breast surgery [unifocal, multifocal, multicentric]
Time frame: Up to 10 years
Number of patients with different pathological subtypes [HER2+/HR- , HER2+/HR+, HER2-/HR+, TNBC]
Time frame: Up to 10 years
Estrogen Receptor positivity [%] Progesterone Receptor positivity [%]
Time frame: Up to 10 years
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 [%]
Time frame: Up to 10 years
Histological type: Invasive ductal, invasive lobular, other.
Time frame: Up to 10 years
Histological grade with using Modified Bloom Richardson grading system: Grade 1, Grade 2, Grade 3
Time frame: Up to 10 years
Nuclear grade: Grade 1, Grade 2, Grade 3
Time frame: Up to 10 years
Tumor Ki-67 proliferation index will be collected
Time frame: Up to 10 years
Number (%) patients receiving neoadjuvant or adjuvant chemotherapy
Time frame: Up to 10 years
Number (%) patients receiving adjuvant hormonotherapy
Time frame: Up to 10 years
Number (%) patients receiving radiotherapy [Stereotactic Body Radiation Therapy (SBRT), conventional radiotherapy or other]
Time frame: Up to 10 years
Number (%) patients underwent surgery [by regions]
Time frame: Up to 10 years
Number (%) patients had locally ablative treatment [by regions]
Time frame: Up to 10 years
Date and site of recurrence [visceral, non-visceral, central nervous system (CNS) and oligometastatic]
Time frame: Up to 10 years
The date of the last review and current clinical condition will be recorded.
Time frame: Up to 10 years
Date and cause of death, when applicable.
Turkish Oncology Group
Network
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07693985
Adherence Interventions, Behavior
Valencia, Spain
View Trial DetailsNCT06386263
Breast Diseases, Breast Neoplasms
Oakville, Ontario, Canada
View Trial DetailsNCT05043506
Breast Diseases, Breast Neoplasms
Braunau am Inn, Austria
View Trial DetailsNCT03323346
Breast Diseases, Breast Neoplasm Female
Olomouc, Czechia
View Trial Details