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Completed

NCT Number: NCT01645059

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

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.

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Key information

Conditions

Disseminated HER2+ Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital de Denia, Denia, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy

    Time frame: one day (there is no follow-up, it is a cross-sectional study)

  2. The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy

    Time frame: one day (there is no follow-up, it si a cross-sectional study)

  3. Adjuvant Treatment and Age

    Time frame: 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)

  4. Adjuvant Treatment-Physical Activity

    Time frame: 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)

  5. Adjuvant Treatment-Node Affectation

    Time frame: 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)

  6. Disseminated Breast Cancer Treatment-Age

    Time frame: one day (there is no follow-up, it is a cross-sectional study)

    Analyse disseminated Breast Cancer treatment and clinical profile (age)

  7. Disseminated Breast Cancer Treatment-physical Activity

    Time frame: one day (there is no follow-up, it is a cross-sectional study)

    Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)

  8. Disseminated Breast Cancer Treatment-Smoking

    Time frame: one day (there is no follow-up, it is a cross-sectional study)

    Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)

Sponsors and collaborators

Lead sponsor

Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica

Network

Registry information

Official study 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)

Acronym: PRIMHER

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.