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NCT Number: NCT01711502

Epidemiology and Management of Metastatic Breast Cancer

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.

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Key information

Conditions

Breast Cancer Nos Metastatic Recurrent Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Doina Coste Gherasim, Baia Mare, Romania

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

    Time frame: At 12 and 18 months after diagnosis

Secondary outcomes

  1. The progression free survival (PFS) rates

    Time frame: At 12 and 18 months after diagnosis

  2. The progression free survival (PFS) time

    Time frame: At 18 months after diagnosis

  3. Time to progression (TTP)

    Time frame: At 18 months after diagnosis

  4. The clinical and pathological characteristics of newly diagnosed MBC patients

    Time frame: At 18 months after diagnosis

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

    Time frame: At 18 months after diagnosis

  6. Health care utilization associated with the disease in Romania

    Time frame: At 18 months after diagnosis

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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