Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy (PRIMHER)

November 20, 2013 updated by: Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica

Observational, Cross-sectional, Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy (PRIMHER)

This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04009
        • Hospital de Torrecárdenas
      • Badajoz, Spain, 06008
        • Hospital Infanta Cristina de Badajoz
      • Barcelona, Spain, 08017
        • Clinica Corachan
      • Ciudad Real, Spain, 13005
        • Complejo Hospitalario Ciudad Real
      • Cáceres, Spain, 10003
        • Hospital San Pedro Alcántara
      • León, Spain, 24008
        • Hospital de Leon
      • Lleida, Spain, 25198
        • Hospital Universitario Arnau de Vilanova
      • Lugo, Spain, 27003
        • Hospital Lucus Augusti
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Murcia, Spain, 30008
        • Hospital Morales Messeguer
      • Segovia, Spain, 40002
        • Hospital General de Segovia
      • Sevilla, Spain, 41009
        • Hospital Virgen de la Macarena
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46017
        • Hospital Dr.Peset
      • Valladolid, Spain, 47012
        • Hospital Universitario Río Hortega
      • Valladolid, Spain, 47005
        • Hospital Clínico de Valladolid
      • Zamora, Spain, 49021
        • Hospital de Zamora
    • Alicante
      • Denia, Alicante, Spain, 03700
        • Hospital de Denia
      • Elda, Alicante, Spain, 03600
        • Hospital General de Elda
    • Asturias
      • Gijón, Asturias, Spain, 33203
        • Hospital de Cabueñes
    • Badajoz
      • Don Benito, Badajoz, Spain, 06400
        • Hospital don Benito
      • Llerena, Badajoz, Spain, 06900
        • Hospital de Llerena
      • Mérida, Badajoz, Spain, 06800
        • Hospital de Mérida
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Ico Badalona
      • Hospitalet de Llobregat, Barcelona, Spain, 08906
        • Hospital General de l'Hospitalet
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Hospital Virgen del Puerto
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11404
        • Hospital de Jerez
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
        • Hospital Son Llatzer
    • Madrid
      • Getafe, Madrid, Spain, 28901
        • Hospital de Getafe
      • Leganés, Madrid, Spain, 28911
        • Hospital Severo Ochoa
      • Móstoles, Madrid, Spain, 28935
        • Hospital De Mostoles
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Quirón
    • Navarra
      • Tudela, Navarra, Spain, 31500
        • Hospital Reina Sofía de Tudela
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36214
        • Hospital Do Meixoeiro
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Hospital Universitario de la Candelaria
    • Teruel
      • Alcañiz, Teruel, Spain, 44600
        • Hospital de Alcañiz
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital de Galdakao
    • Álava
      • Vitoria, Álava, Spain, 01009
        • Hospital de Txagorritxu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients with disseminated HER2+ breast cancer in first line treatment

Description

Inclusion Criteria:

  • Women with 18 years or over
  • Patients with disseminated breast cancer histologically or cytological confirmed, who begins with Her 2+ metastatic breast cancer or develops a metastasis after or during the adjuvant therapy
  • Patients treated in first line treatment in metastatic disease.
  • Patients who have positive Her 2 receptor test
  • Patients who have given their written informed consent

Exclusion Criteria:

  • Patients who are participating in other studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Time Frame: 1 day (there is no follow-up, it is a cross-sectional study)
General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis
1 day (there is no follow-up, it is a cross-sectional study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Time Frame: one day (there is no follow-up, it is a cross-sectional study)
one day (there is no follow-up, it is a cross-sectional study)
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Time Frame: one day (there is no follow-up, it si a cross-sectional study)
one day (there is no follow-up, it si a cross-sectional study)
Adjuvant Treatment and Age
Time Frame: one day (there is no follow-up, it is a cross-sectional study)

Adjuvant treatment and clinical profile (age)

The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
one day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment-Physical Activity
Time Frame: one day (there is no follow-up, it is a cross-sectional study)

Adjuvant treatment and clinical profile (Physical activity)

The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
one day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment-Node Affectation
Time Frame: one day (there is no follow-up, it is a cross-sectional study)

Adjuvant treatment and clinical profile (Node affectation)

The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-Age
Time Frame: one day (there is no follow-up, it is a cross-sectional study)
Analyse disseminated Breast Cancer treatment and clinical profile (age)
one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-physical Activity
Time Frame: one day (there is no follow-up, it is a cross-sectional study)
Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-Smoking
Time Frame: one day (there is no follow-up, it is a cross-sectional study)
Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
one day (there is no follow-up, it is a cross-sectional study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica

Investigators

  • Principal Investigator: Mª Helena López Ceballos, MD, Hospital San Pedro Alcántara
  • Principal Investigator: Santiago González Santiago, MD, Hospital San Pedro Alcántara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2014

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACI-CMM-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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