NCT04247035

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

January 24, 2020

Last Update Submit

February 9, 2021

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Active malignancy other than MBC
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hellenic Society of Medical Oncology

Athens, 11475, Greece

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ioannis Boukovinas, Dr /Phd

    HeSMO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Agelaki, prof

CONTACT

+302106457971agelakisofia@gmail.com

Kalliopi Sarikaki

CONTACT

+302106457971psarikaki@hesmo.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 29, 2020

Study Start

January 31, 2019

Primary Completion

January 31, 2022

Study Completion

January 31, 2024

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

GR(1)