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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Disseminated HER2+ Breast Cancer
- Sponsor
- Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica
- Enrollment
- 129
- Locations
- 39
- Primary Endpoint
- The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Adjuvant Treatment-Node Affectation(one day (there is no follow-up, it is a cross-sectional study))
- 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))
- Adjuvant Treatment and Age(one day (there is no follow-up, it is a cross-sectional study))
- Adjuvant Treatment-Physical Activity(one day (there is no follow-up, it is a cross-sectional study))
- Disseminated Breast Cancer Treatment-Age(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(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))