Clinical trial · Observational
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
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)
NCT01645059CI-TRIAL-00013356PRIMHERcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disseminated HER2+ Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
- description
- 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 (8)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.