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
- Conditions
- Disseminated HER2+ Breast Cancer
- Registration Number
- NCT01645059
- Lead Sponsor
- Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
- 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
- Patients who are participating in other studies
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) 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
- Secondary Outcome Measures
Name Time Method Adjuvant Treatment-Node Affectation 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)Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy one day (there is no follow-up, it is a cross-sectional study) Disseminated Breast Cancer Treatment-Smoking one day (there is no follow-up, it is a cross-sectional study) Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
Adjuvant Treatment and Age 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)Adjuvant Treatment-Physical Activity 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)Disseminated Breast Cancer Treatment-Age one day (there is no follow-up, it is a cross-sectional study) Analyse disseminated Breast Cancer treatment and clinical profile (age)
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy one day (there is no follow-up, it si a cross-sectional study) Disseminated Breast Cancer Treatment-physical Activity one day (there is no follow-up, it is a cross-sectional study) Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
Trial Locations
- Locations (39)
Hospital de Denia
🇪🇸Denia, Alicante, Spain
Hospital General de Elda
🇪🇸Elda, Alicante, Spain
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital don Benito
🇪🇸Don Benito, Badajoz, Spain
Hospital de Llerena
🇪🇸Llerena, Badajoz, Spain
Hospital de Mérida
🇪🇸Mérida, Badajoz, Spain
ICO Badalona
🇪🇸Badalona, Barcelona, Spain
Hospital General de l'Hospitalet
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Virgen del Puerto
🇪🇸Plasencia, Cáceres, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Cádiz, Spain
Scroll for more (29 remaining)Hospital de Denia🇪🇸Denia, Alicante, Spain