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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)


N/A
18 Years
N/A
Open (Enrolling)
Female
Disseminated HER2+ Breast Cancer

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Trial Information

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)


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

The patient clinical profile (general clinical data and breast cancer characteristics)

Outcome Description:

General clinical data: age, weigh, height, ECOG functionality Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM, tumor size, node involvement, primary tumor surgery, HER2 overexpression, time from the primary breast cancer to distant relapse, description and localization of metastasis

Outcome Time Frame:

1 day (there is no follow-up, it is a cross-sectional study)

Safety Issue:

No

Principal Investigator

Mª Helena López Ceballos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital San Pedro Alcántara

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

ACI-CMM-2010-01

NCT ID:

NCT01645059

Start Date:

July 2011

Completion Date:

March 2013

Related Keywords:

  • Disseminated HER2+ Breast Cancer
  • Breast Neoplasms
  • Neoplasm Metastasis

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