Epidemiology and Management of Metastatic Breast Cancer

NCT01711502 | Completed

• 1 other identifier: NIS-ORO-XXX-2012/1
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 15

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.

Conditions

Breast Cancer Nos Metastatic Recurrent

Keywords

metastatic breast cancer,; epidemiology,; retrospective cohort

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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)

  At 18 months after diagnosis

• The clinical and pathological characteristics of newly diagnosed MBC patients

  At 18 months after diagnosis

• The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients

  At 18 months after diagnosis

Study Arms (1)

Female patients diagosed with metastatic breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Doina Coste Gherasim

Baia Mare, Romania

Location

Daniel Ciurescu

Brasov, Romania

Location

Dana Lucia Stanculeanu

Bucharest, Romania

Location

Dragos Median

Bucharest, Romania

Location

Mircea Dediu

Bucharest, Romania

Location

Rodica Tudor

Bucharest, Romania

Location

Alexandru Eniu

Cluj-Napoca, Romania

Location

Gabriela Morar Bolba

Cluj-Napoca, Romania

Location

Bena Sandra

Craiova, Romania

Location

Nelly Cherciu

Craiova, Romania

Location

Diana Petroiu

Iași, Romania

Location

Simona Angelescu

Târgovişte, Romania

Location

Cristina Oprean

Timișoara, Romania

Location

Stefan Curescu

Timișoara, Romania

Location

Cristina Elen Pirau

Vaslui, Romania

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dediu Mrcea, SENIOR PHYSICIAN

  Bucharest Institute of Oncology

  PRINCIPAL INVESTIGATOR

• Alexandru Eniu, SENIOR PHYSICIAN

  Cluj Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

RO (15)