Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group (ALAMO-IV)

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

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).

Study Overview

• Status: Completed
• Conditions: Invasive Breast Cancer Between 2002 and 2005

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 13135

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • A Coruña, Spain, 15009
    • Centro Oncologico de Galicia
  • Albacete, Spain, 02006
    • Complejo Hospitalario de Albacete
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08916
    • Hospital Clinic I Provincial
  • Cadiz, Spain, 11009
    • Hospital Universitario Puerta Del Mar
  • Cuenca, Spain, 16002
    • Hospital General Virgen de la Luz
  • Girona, Spain, 17007
    • Hospital Josep Trueta
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28006
    • Hospital Universitario La Prinesa
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de La Arrixaca
  • Ourense, Spain, 32005
    • Complejo Hospitalario Universitario De Ourense
  • Toledo, Spain, 45071
    • Hospital Universitario Virgen de La Salud
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46006
    • Instituto Valenciano de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Zaragoza, Spain, 50009
    • Hospital Clínico Universitario de Zaragoza Lozano Blesa
  • Ávila, Spain, 05004
    • Hospital Nuestra Señora de Sonsoles
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
    • Elda, Alicante, Spain, 03600
      • Hospital General Universitario de Elda - Virgen de la Salud
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
    • Granollers, Barcelona, Spain, 08400
      • Hospital General De Granollers
    • Mataró, Barcelona, Spain, 08304
      • Hospital de Mataró-Consorci Sanitari del Maresme
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
    • Terrassa, Barcelona, Spain, 08227
      • Consorci Sanitari de Terrassa
  • Guipuzcoa
    • Donostia-San Sebastián, Guipuzcoa, Spain, 20014
      • Onkologikoa
  • Gupúzcoa
    • Donostia-San Sebastián, Gupúzcoa, Spain, 20014
      • Hospital Universitario de Donostia
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrin
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundación Alrcorcón
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro de Majadahonda
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario Canarias
  • Valencia
    • Alcoy, Valencia, Spain, 03804
      • Hospital Virgen de los Lirios
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario de Basurto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spanish Breast Cancer Research Group
• Collaborators: Instituto de Salud Carlos III

Publications and helpful links

General Publications

• Lopez-Tarruella S, Escudero MJ, Pollan M, Martin M, Jara C, Bermejo B, Guerrero-Zotano A, Garcia-Saenz J, Santaballa A, Alba E, Andres R, Martinez P, Calvo L, Fernandez A, Batista N, Llombart-Cussac A, Anton A, Lahuerta A, de la Haba J, Lopez-Vega JM, Carrasco E. Survival impact of primary tumor resection in de novo metastatic breast cancer patients (GEICAM/El Alamo Registry). Sci Rep. 2019 Dec 27;9(1):20081. doi: 10.1038/s41598-019-55765-9.

Helpful Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2016
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ÁLAMO IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No