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
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Almería, Spain, 04009
- Hospital de Torrecardenas
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Badajoz, Spain, 06008
- Hospital Infanta Cristina de Badajoz
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Barcelona, Spain, 08017
- Clínica Corachan
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Ciudad Real, Spain, 13005
- Complejo Hospitalario Ciudad Real
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Cáceres, Spain, 10003
- Hospital San Pedro Alcántara
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León, Spain, 24008
- Hospital de Leon
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Lleida, Spain, 25198
- Hospital Universitario Arnau de Vilanova
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Lugo, Spain, 27003
- Hospital Lucus Augusti
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Madrid, Spain, 28006
- Hospital La Princesa
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Murcia, Spain, 30008
- Hospital Morales Messeguer
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Segovia, Spain, 40002
- Hospital General de Segovia
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Sevilla, Spain, 41009
- Hospital Virgen de la Macarena
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Valencia, Spain, 46014
- Hospital General Universitario de Valencia
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Valencia, Spain, 46017
- Hospital Dr.Peset
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Valladolid, Spain, 47012
- Hospital Universitario Rio Hortega
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Valladolid, Spain, 47005
- Hospital Clínico de Valladolid
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Zamora, Spain, 49021
- Hospital de Zamora
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Alicante
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Denia, Alicante, Spain, 03700
- Hospital de Denia
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Elda, Alicante, Spain, 03600
- Hospital General de Elda
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Asturias
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Gijón, Asturias, Spain, 33203
- Hospital de Cabueñes
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Badajoz
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Don Benito, Badajoz, Spain, 06400
- Hospital don Benito
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Llerena, Badajoz, Spain, 06900
- Hospital de Llerena
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Mérida, Badajoz, Spain, 06800
- Hospital de Merida
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Ico Badalona
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Hospitalet de Llobregat, Barcelona, Spain, 08906
- Hospital General de l'Hospitalet
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Cáceres
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Plasencia, Cáceres, Spain, 10600
- Hospital Virgen del Puerto
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Cádiz
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Jerez de la Frontera, Cádiz, Spain, 11404
- Hospital de Jerez
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spain, 07198
- Hospital Son Llatzer
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Madrid
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Getafe, Madrid, Spain, 28901
- Hospital de Getafe
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Leganés, Madrid, Spain, 28911
- Hospital Severo Ochoa
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Móstoles, Madrid, Spain, 28935
- Hospital De Mostoles
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Pozuelo de Alarcón, Madrid, Spain, 28223
- Hospital Quirón
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Navarra
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Tudela, Navarra, Spain, 31500
- Hospital Reina Sofía de Tudela
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Pontevedra
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Vigo, Pontevedra, Spain, 36214
- Hospital Do Meixoeiro
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Tenerife
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La Laguna, Tenerife, Spain, 38320
- Hospital Universitario de Canarias
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Santa Cruz de Tenerife, Tenerife, Spain, 38010
- Hospital Universitario de la Candelaria
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Teruel
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Alcañiz, Teruel, Spain, 44600
- Hospital de Alcañiz
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Vizcaya
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Galdakao, Vizcaya, Spain, 48960
- Hospital de Galdakao
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Álava
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Vitoria, Álava, Spain, 01009
- Hospital de Txagorritxu
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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 |
|---|---|---|
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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)
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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)
|
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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)
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Analyse disseminated Breast Cancer treatment and clinical profile (age)
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one day (there is no follow-up, it is a cross-sectional study)
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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)
|
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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.
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.