Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group

Study Overview
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Brief Summary
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This study is a non-interventional (NIS), multicenter, retrospective cohort study, which will obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the medical oncology departments of hospitals that are members of GEICAM (using information obtained from patient medical histories).

Detailed Description
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There is no specific treatment regimen for this study. This is an observational retrospective study in which the clinical decisions concerning the optimal strategy in the treatment of the disease for each patient have been taken independently and prior to the physician's decision to include patient data in this registry, in keeping with the drug information, local treatment guidelines and/or standard clinical practice. The study target population are all patients (men and women) who have been newly diagnosed with invasive breast cancer between January 1, 2002 and December 31, 2005 and treated in the medical oncology departments of participating sites, ensuring an approximate follow-up of 10 years.

Official Title
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Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV

Conditions
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Invasive Breast Cancer Between 2002 and 2005

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose first primary breast invasive tumor diagnosis occurred between January 1, 2002 and December 31, 2005 and who have received treatment in the medical oncology departments of participating sites. Patients who were diagnosed at the participating site; otherwise the site where the initial diagnosis was made should be contacted with in order to confirm that the patient has not already been enrolled in the study or pending inclusion. The objective is to avoid duplicate records for displaced patients. Exclusion Criteria: Patients with a single diagnosis of in situ carcinoma (without infiltrating component).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study demographic | Number of participants with the demographic characteristics: Age, sex, race of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals. | 30 months | 
| Study clinical and anatomic-pathological | In the 12.000 patients included to study the clinical and anatomic-pathological characteristics: primary tumor, regional nodes, metastasis status (TNM), date of initial diagnosis of Breast Cancer (BC), biomarkers of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Breast Cancer in terms of frequency | In the 12.000 patients included to describe the evolution of breast cancer patients in terms of frequency (time). | 30 months | 
| Evolution of Breast Cancer in terms of type | In the 12.000 patients included to describe the evolution of breast cancer patients in terms of type of relapse. | 30 months | 
| Evolution of Breast Cancer in terms of location of relapse | In the 12.000 patients included to describe the evolution of breast cancer patients in terms of location of relapse. | 30 months | 
| Family history of Breast Cancer | Number of patients with a family history of breast cancer. | 30 months | 
| Characteristics of family history of Breast Cancer | Characteristics clinical-pathological of patients with a family history of breast cancer. | 30 months | 
| Differences in Breast Cancer between sex | Differences clinical-pathological between men and women with breast cancer | 30 months | 
| Quantify the influence of type of surgery conducted on primary tumor | In the 12.000 patients included to quantify the influence of type of surgery conducted on primary tumor | 30 months | 
| Number of patients with metastatic disease as first diagnosis | In the 12.000 patients included to quantify the influence of timepoint of primary tumor surgery in patients with metastatic disease as first diagnosis | 30 months | 
| Quantify the prevalence of breast cancer related to pregnancy | In the 12.000 patients included to quantify the prevalence of breast cancer related to pregnancy | 30 months |