Disseminated HER2+ Breast Cancer Clinical Trial
— PRIMHEROfficial 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)
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.
| Status | Completed |
| Enrollment | 129 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital de Alcañiz | Alcañiz | Teruel |
| Spain | Hospital de Torrecárdenas | Almería | |
| Spain | Hospital Infanta Cristina de Badajoz | Badajoz | |
| Spain | ICO Badalona | Badalona | Barcelona |
| Spain | Clínica Corachan | Barcelona | |
| Spain | Hospital San Pedro Alcántara | Cáceres | |
| Spain | Complejo Hospitalario Ciudad Real | Ciudad Real | |
| Spain | Hospital de Denia | Denia | Alicante |
| Spain | Hospital don Benito | Don Benito | Badajoz |
| Spain | Hospital General de Elda | Elda | Alicante |
| Spain | Hospital de Galdakao | Galdakao | Vizcaya |
| Spain | Hospital de Getafe | Getafe | Madrid |
| Spain | Hospital de Cabueñes | Gijón | Asturias |
| Spain | Hospital General de l'Hospitalet | Hospitalet de Llobregat | Barcelona |
| Spain | Hospital de Jerez | Jerez de la Frontera | Cádiz |
| Spain | Hospital Universitario de Canarias | La Laguna | Tenerife |
| Spain | Hospital Severo Ochoa | Leganés | Madrid |
| Spain | Hospital de León | León | |
| Spain | Hospital Universitario Arnau de Vilanova | Lleida | |
| Spain | Hospital de Llerena | Llerena | Badajoz |
| Spain | Hospital Lucus Augusti | Lugo | |
| Spain | Hospital La Princesa | Madrid | |
| Spain | Hospital de Mérida | Mérida | Badajoz |
| Spain | Hospital de Móstoles | Móstoles | Madrid |
| Spain | Hospital Morales Messeguer | Murcia | |
| Spain | Hospital Son Llàtzer | Palma de Mallorca | Islas Baleares |
| Spain | Hospital Virgen del Puerto | Plasencia | Cáceres |
| Spain | Hospital Quirón | Pozuelo de Alarcón | Madrid |
| Spain | Hospital Universitario de la Candelaria | Santa Cruz de Tenerife | Tenerife |
| Spain | Hospital General de Segovia | Segovia | |
| Spain | Hospital Virgen de la Macarena | Sevilla | |
| Spain | Hospital Reina Sofía de Tudela | Tudela | Navarra |
| Spain | Hospital Dr.Peset | Valencia | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital Clínico de Valladolid | Valladolid | |
| Spain | Hospital Universitario Rio Hortega | Valladolid | |
| Spain | Hospital do Meixoeiro | Vigo | Pontevedra |
| Spain | Hospital de Txagorritxu | Vitoria | Álava |
| Spain | Hospital de Zamora | Zamora |
| Lead Sponsor | Collaborator |
|---|---|
| Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) | 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) | No |
| Secondary | 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) | No | |
| Secondary | 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) | No | |
| Secondary | Adjuvant Treatment and Age | 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) | No |
| Secondary | Adjuvant Treatment-Physical Activity | 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) | No |
| Secondary | Adjuvant Treatment-Node Affectation | 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) | No |
| Secondary | Disseminated Breast Cancer Treatment-Age | Analyse disseminated Breast Cancer treatment and clinical profile (age) | one day (there is no follow-up, it is a cross-sectional study) | No |
| Secondary | Disseminated Breast Cancer Treatment-physical Activity | Analyse disseminated Breast Cancer treatment and clinical profile (physical activity) | one day (there is no follow-up, it is a cross-sectional study) | No |
| Secondary | Disseminated Breast Cancer Treatment-Smoking | Analyse disseminated Breast Cancer treatment and clinical profile (Smoking) | one day (there is no follow-up, it is a cross-sectional study) | No |