Clinical trial NCT01711502: Epidemiology and Management of Metastatic Breast Cancer
Official title: Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Nos Metastatic Recurrent
Keywords: metastatic breast cancer,
epidemiology,
retrospective cohort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients diagosed with metastatic breast cance, age \> 18 years

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

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)

Primary outcomes:
measure: 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
timeFrame: At 12 and 18 months after diagnosis
Secondary outcomes:
measure: The progression free survival (PFS) rates
timeFrame: At 12 and 18 months after diagnosis
measure: The progression free survival (PFS) time
timeFrame: At 18 months after diagnosis
measure: Time to progression (TTP)
timeFrame: At 18 months after diagnosis
measure: The clinical and pathological characteristics of newly diagnosed MBC patients
timeFrame: At 18 months after diagnosis
measure: The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients
timeFrame: At 18 months after diagnosis
measure: Health care utilization associated with the disease in Romania
timeFrame: At 18 months after diagnosis
Other outcomes:
Locations:
city: Baia Mare
country: Romania
facility: Doina Coste Gherasim
city: Brasov
country: Romania
facility: Daniel Ciurescu
city: Bucharest
country: Romania
facility: Dana Lucia Stanculeanu
city: Bucharest
country: Romania
facility: Dragos Median
city: Bucharest
country: Romania
facility: Mircea Dediu
city: Bucharest
country: Romania
facility: Rodica Tudor
city: Cluj
country: Romania
facility: Alexandru Eniu
city: Cluj
country: Romania
facility: Gabriela Morar Bolba
city: Craiova
country: Romania
facility: Bena Sandra
city: Craiova
country: Romania
facility: Nelly Cherciu
city: Iasi
country: Romania
facility: Diana Petroiu
city: Targoviste
country: Romania
facility: Simona Angelescu
city: Timisoara
country: Romania
facility: Cristina Oprean
city: Timisoara
country: Romania
facility: Stefan Curescu
city: Vaslui
country: Romania
facility: Cristina Elen Pirau
Study officials:
affiliation: Bucharest Institute of Oncology
name: Dediu Mrcea, SENIOR PHYSICIAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Cluj Institute of Oncology
name: Alexandru Eniu, SENIOR PHYSICIAN
role: PRINCIPAL_INVESTIGATOR
References: