Τreatment Standards and Outcomes of Patients With ER/PR P... | NCT04247035

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

NCT04247035

Sponsor

Hellenic Society of Medical Oncology

Status

Unknown status

Last Update Posted

Feb 10, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Metastatic Breast Cancer

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2019Actual

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Jan 31, 2024Estimated

First Submitted Date

Jan 24, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sofia Agelaki, prof	Contact	+302106457971		agelakisofia@gmail.com
Kalliopi Sarikaki	Contact	+302106457971		psarikaki@hesmo.gr

Overall Officials

Name	Affiliation	Role
Ioannis Boukovinas, Dr /Phd	HeSMO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hellenic Society of Medical Oncology	Recruiting	Athens		11475	Greece

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided