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

February 9, 2021 updated by: Hellenic Society of Medical Oncology

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 11475
        • Recruiting
        • Hellenic Society of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Women with histological confirmed ER/PR positive, HER2-negative MBC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the outcome per treatment line
Time Frame: 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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Society of Medical Oncology

Investigators

  • Principal Investigator: Ioannis Boukovinas, Dr /Phd, HeSMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2019

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metastatic Breast Cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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