NCT04770129

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

February 15, 2021

Last Update Submit

January 19, 2023

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (21)

  • Time to progression (TTP)

    Up to 10 years

  • Demographic characteristics at baseline

    Up to 10 years

  • Clinical and pathological characteristics: Diagnosis

    Up to 10 years

  • Clinical and pathological characteristics: Clinical and/or pathological stage

    Up to 10 years

  • Clinical and pathological characteristics: Lymph nodes

    Up to 10 years

  • +16 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ege University Hospital

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Acibadem Maslak Hospital

Istanbul, Maslak, 34457, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

Acibadem Altunizade Hospital, Istanbul

Istanbul, Üsküdar, 34662, Turkey (Türkiye)

Location

American Hospital

Istanbul, Şişli, 34365, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 25, 2021

Study Start

March 22, 2021

Primary Completion

June 2, 2022

Study Completion

August 8, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

TU(6)