Epidemiology and Management of Metastatic Breast Cancer | NCT01711502

Studies
Epidemiology and Management of Metastatic Breast Cancer

NCT01711502

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 30, 2014Estimated

Enrollment

128Actual

Phase

Not provided

Conditions

Breast Cancer Nos Metastatic Recurrent

Interventions

Not provided

Countries

Romania

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Oct 18, 2012

First Submission Date that Met QC Criteria

Oct 18, 2012

First Posted Date

Oct 22, 2012Estimated

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

Jan 29, 2014

Last Update Posted Date

Jan 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.

Detailed Description

Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Label	Type	Description	Intervention Names
Female patients diagosed with metastatic breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage		At 12 and 18 months after diagnosis

Secondary Outcomes

Measure	Description	Time Frame
The progression free survival (PFS) rates		At 12 and 18 months after diagnosis
The progression free survival (PFS) time		At 18 months after diagnosis
Time to progression (TTP)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis
Confirmed diagnosis between 1st July 2010 - 30th June 2011
Female patient managed for her disease at the same setting where final diagnosis of MBC was performed

Exclusion Criteria:

History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female patients diagosed with metastatic breast cance, age > 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dediu Mrcea, SENIOR PHYSICIAN	Bucharest Institute of Oncology	Principal Investigator
Alexandru Eniu, SENIOR PHYSICIAN	Cluj Institute of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Doina Coste Gherasim		Baia Mare			Romania
Daniel Ciurescu

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