Clinical trial NCT01645059: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disseminated HER2+ Breast Cancer
Lead sponsor: Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica
Sponsor class: NETWORK
First posted: 2012-07-20
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with disseminated HER2+ breast cancer in first line treatment

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
timeFrame: 1 day (there is no follow-up, it is a cross-sectional study)
Secondary outcomes:
measure: Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
measure: The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
timeFrame: one day (there is no follow-up, it si a cross-sectional study)
measure: Adjuvant Treatment and Age
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
measure: Adjuvant Treatment-Physical Activity
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
measure: Adjuvant Treatment-Node Affectation
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
measure: Disseminated Breast Cancer Treatment-Age
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
measure: Disseminated Breast Cancer Treatment-physical Activity
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
measure: Disseminated Breast Cancer Treatment-Smoking
timeFrame: one day (there is no follow-up, it is a cross-sectional study)
Other outcomes:
Locations:
city: Denia
country: Spain
facility: Hospital de Denia
state: Alicante
city: Elda
country: Spain
facility: Hospital General de Elda
state: Alicante
city: Gijón
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Don Benito
country: Spain
facility: Hospital don Benito
state: Badajoz
city: Llerena
country: Spain
facility: Hospital de Llerena
state: Badajoz
city: Mérida
country: Spain
facility: Hospital de Mérida
state: Badajoz
city: Badalona
country: Spain
facility: ICO Badalona
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital General de l'Hospitalet
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto
state: Cáceres
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Islas Baleares
city: Getafe
country: Spain
facility: Hospital de Getafe
state: Madrid
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Móstoles
country: Spain
facility: Hospital de Móstoles
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Quirón
state: Madrid
city: Tudela
country: Spain
facility: Hospital Reina Sofía de Tudela
state: Navarra
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
state: Pontevedra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de la Candelaria
state: Tenerife
city: Alcañiz
country: Spain
facility: Hospital de Alcañiz
state: Teruel
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Almería
country: Spain
facility: Hospital de Torrecárdenas
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina de Badajoz
city: Barcelona
country: Spain
facility: Clínica Corachan
city: Ciudad Real
country: Spain
facility: Complejo Hospitalario Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro Alcántara
city: León
country: Spain
facility: Hospital de León
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Dr.Peset
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Zamora
country: Spain
facility: Hospital de Zamora
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
state: Álava
Study officials:
affiliation: Hospital San Pedro Alcántara
name: Mª Helena López Ceballos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Pedro Alcántara
name: Santiago González Santiago, MD
role: PRINCIPAL_INVESTIGATOR
References: