Metastatic Breast CancerNCT04770129
Real-World Data on Clinical Characteristics, Demographics, and Outcomes of Patients With Metastatic Breast Cancer in Turkey
An observational study of Metastatic Breast Cancer, run by Turkish Oncology Group at 6 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 1,331 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 22 Mar 2021to 8 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who were referred to the participating centers for further treatment for a second opinion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Istanbul University
Istanbul, Fatih, 34093
Acibadem Maslak Hospital
Istanbul, Maslak, 34457
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
Acibadem Altunizade Hospital, Istanbul
Istanbul, Üsküdar, 34662
American Hospital
Istanbul, Şişli, 34365
Ege University Hospital
Izmir, Bornova, 35100
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 10 years
Secondary outcomes (21)
Time to progression (TTP)
Time to progression is measured as the time from study entry to the development of disease progression.
Measured: Up to 10 years
Demographic characteristics at baseline
- Patient demographics: age and gender.
- Type of insurance (social security system, private insurance) [if available]
Measured: Up to 10 years
Clinical and pathological characteristics: Diagnosis
Date and stage of diagnosis
Measured: 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
Measured: Up to 10 years
Clinical and pathological characteristics: Lymph nodes
Number (N) of lymph nodes involved / retrieved
Measured: 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]
Measured: Up to 10 years
Clinical and pathological characteristics: Pathological subtype
Number of patients with different pathological subtypes [HER2+/HR- , HER2+/HR+, HER2-/HR+, TNBC]
Measured: Up to 10 years
Clinical and pathological characteristics: Hormone-receptor expression
Estrogen Receptor positivity [%] Progesterone Receptor positivity [%]
Measured: 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 [%]
Measured: Up to 10 years
Clinical and pathological characteristics: Histological type
Histological type: Invasive ductal, invasive lobular, other.
Measured: 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
Measured: Up to 10 years
Clinical and pathological characteristics: Nuclear grade
Nuclear grade: Grade 1, Grade 2, Grade 3
Measured: Up to 10 years
Anatomopathological characteristics of the tumor: Ki-67
Tumor Ki-67 proliferation index will be collected
Measured: Up to 10 years
Treatment data: type of chemotherapy
Number (%) patients receiving neoadjuvant or adjuvant chemotherapy
Measured: Up to 10 years
Treatment data: adjuvant hormonotherapy
Number (%) patients receiving adjuvant hormonotherapy
Measured: Up to 10 years
Treatment data: radiotherapy
Number (%) patients receiving radiotherapy [Stereotactic Body Radiation Therapy (SBRT), conventional radiotherapy or other]
Measured: Up to 10 years
Treatment data: surgery
Number (%) patients underwent surgery [by regions]
Measured: Up to 10 years
Treatment data: locally ablative treatment
Number (%) patients had locally ablative treatment [by regions]
Measured: Up to 10 years
Follow-up data: initial recurrence
Date and site of recurrence [visceral, non-visceral, central nervous system (CNS) and oligometastatic]
Measured: Up to 10 years
Follow-up data: current condition
The date of the last review and current clinical condition will be recorded.
Measured: Up to 10 years
Follow-up data: date and cause of death
Date and cause of death, when applicable.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start22 Mar 2021
- Primary completion2 Jun 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Oncology Group
- Sponsor type
- Research network
- Collaborators
- Acibadem Maslak Hospital, Ege University Hospital, Marmara University Pendik Training and Research Hospital, Acibadem Altunizade Hospital, Istanbul, Istanbul University, V.K.V. American Hospital, Istanbul, Hacettepe University
- Responsible party
- Principal investigator, Yesim Eralp, Acibadem Maslak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770129
- Sponsor's protocol ID
- ML42450
- Status last verified
- Jan 2023
- First submitted
- 15 Feb 2021
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04770129
- Acronym / sponsor ID
- ML42450
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,331 participants (actual)
- Lead sponsor
- Turkish Oncology GroupResearch network
- Collaborators
- Acibadem Maslak Hospital, Ege University Hospital, Marmara University Pendik Training and Research Hospital, Acibadem Altunizade Hospital, Istanbul, Istanbul University, V.K.V. American Hospital, Istanbul, Hacettepe University
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who were referred to the participating centers for further treatment for a second opinion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment outcome data: Overall survival (OS)
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
Treatment outcome data: Progression-free survival (PFS)
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
21 secondary outcomes
Time to progression (TTP)
Time frame: Up to 10 years
Demographic characteristics at baseline
Time frame: Up to 10 years
Clinical and pathological characteristics: Diagnosis
Time frame: Up to 10 years
Clinical and pathological characteristics: Clinical and/or pathological stage
Time frame: Up to 10 years
Clinical and pathological characteristics: Lymph nodes
Time frame: Up to 10 years
Clinical and pathological characteristics: Tumor size
Time frame: Up to 10 years
Clinical and pathological characteristics: Pathological subtype
Time frame: Up to 10 years
Clinical and pathological characteristics: Hormone-receptor expression
Time frame: Up to 10 years
Clinical and pathological characteristics: Human Epidermal Growth Factor Receptor 2 (HER-2) expression
Time frame: Up to 10 years
Clinical and pathological characteristics: Histological type
Time frame: Up to 10 years
Clinical and pathological characteristics: Histological grade
Time frame: Up to 10 years
Clinical and pathological characteristics: Nuclear grade
Time frame: Up to 10 years
Anatomopathological characteristics of the tumor: Ki-67
Time frame: Up to 10 years
Treatment data: type of chemotherapy
Time frame: Up to 10 years
Treatment data: adjuvant hormonotherapy
Time frame: Up to 10 years
Treatment data: radiotherapy
Time frame: Up to 10 years
Treatment data: surgery
Time frame: Up to 10 years
Treatment data: locally ablative treatment
Time frame: Up to 10 years
Follow-up data: initial recurrence
Time frame: Up to 10 years
Follow-up data: current condition
Time frame: Up to 10 years
Follow-up data: date and cause of death
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Turkish Oncology Group at 6 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment outcome data: Overall survival (OS) (time frame: Up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.