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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04247035

Acronym

MBC

Enrollment

300

Registered

2020-01-29

Start date

2019-01-31

Completion date

2024-01-31

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Greece

Contacts

Primary ContactSofia Agelaki, prof

agelakisofia@gmail.com+302106457971

Backup ContactKalliopi Sarikaki

psarikaki@hesmo.gr+302106457971

Outcome results