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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04247035
Other study ID # Metastatic Breast Cancer
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 31, 2019
Est. completion date January 31, 2024

Study information

Verified date February 2021
Source Hellenic Society of Medical Oncology
Contact Sofia Agelaki, prof
Phone +302106457971
Email agelakisofia@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

• To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece


Description:

- To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece - To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival - To record adverse events per line of therapy - To recording of the causes of treatment discontinuation per line of therapy


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date January 31, 2024
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women with histological confirmed ER/PR positive, HER2-negative MBC - Age >18 years old - Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC - Adequate hematologic, renal and hepatic function - Signed informed consent (ICF) Exclusion Criteria: - Active malignancy other than MBC - Active infection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Greece Hellenic Society of Medical Oncology Athens

Sponsors (1)

Lead Sponsor Collaborator
Hellenic Society of Medical Oncology

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the outcome per treatment line To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival 5 years
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