Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

— MBC  

Official title:

Non-Interventional, Multi-center Registry of Recording of Treatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247035
• Other study ID #: Metastatic Breast Cancer
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

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