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

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT04247035
• Lead Sponsor: Hellenic Society of Medical Oncology

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-01-31
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2022-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the outcome per treatment line	5 years	To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival

Trial Locations

Locations (1)

Hellenic Society of Medical Oncology; 🇬🇷 Athens, Greece