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

NCT ID: NCT04247035

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-31

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hellenic Society of Medical Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ioannis Boukovinas, Dr /Phd

Role: PRINCIPAL_INVESTIGATOR

HeSMO

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hellenic Society of Medical Oncology

Athens, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sofia Agelaki, prof

Role: CONTACT

+302106457971

Kalliopi Sarikaki

Role: CONTACT

+302106457971

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kalliopi Sarikaki, SC

Role: primary

+302106457971

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Metastatic Breast Cancer

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tumour Registry Breast Cancer
NCT01351584 COMPLETED