Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years (LongHer)

Observational, Cross-sectional Study to Analyze the Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete Remission, Partial Remission or Stabilization of Disease During More Than 3 Years

Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or stable disease for a period exceeding 3 years.

In addition, there will be a sub-genetic analysis of patients in whom there is availability a sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with routine clinical practice, as the tumor samples based on which will be held on genetic profile, have been preserved in paraffin was extracted from the primary tumor to the patient.

Study Overview

• Status: Completed
• Conditions: HER-2 Positive Breast Cancer

Detailed Description

SECONDARY OBJECTIVES:

• To determine the frequency of patients achieving partial response or stable disease for a period exceeding 3 years.
• Know the time to complete or partial remission or to achieve stabilization of the disease.
• Know the length of the complete or partial remission or time to disease stabilization of patients.
• Knowing the pattern of treatment that has achieved complete or partial remission or stabilization of disease and duration.
• Knowledge of overall survival.
• Knowing the toxicity of prolonged administration of trastuzumab.
• Identify the primary tumor genes HER-2 associated with such prolonged responses.

The source document will be in all cases the clinical history and in the case of patients selected for the sub-genetic analysis, the report resulting from it.

The study is carried out by filling a notebook of electronic data collection that gathers all available information contained in medical records.

The sub-genetic analysis will be performed at the Hospital de la Paz. Both, the processing of samples and conducting the analysis using qRT-PCR, will be performed in this hospital.

All data are stored, ensuring the confidentiality, security and authenticity .The forms must be reviewed by the monitor.

Once recorded the data, the database will be revised and monitored to submit those records in which there are inconsistencies or missing information . Following the closure of the database will be a report which will present the results of the analysis of the data.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15003
    • Hospital oncológico de Galicia
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Barcelona, Spain, 08025
    • Hospital Sant Pau
  • Burgos, Spain, 09005
    • Hospital General Yagüe
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves
  • Granada, Spain, 18012
    • Hospital Clínico San Cecilio
  • Guadalajara, Spain, 19002
    • Hospital de Guadalajara
  • Huelva, Spain, 21005
    • Hospital Juan Ramón Jimenez
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Madrid, Spain, 28033
    • MD Anderson
  • Madrid, Spain, 28041
    • Hsopital Doce de Octubre
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Sevilla, Spain
    • Hospital Virgen del Rocío
  • Sevilla, Spain, 41014
    • Hospital Nuestra Señora de Valme
  • Valencia, Spain
    • Hospital La Fe
  • Valladolid, Spain, 47012
    • Hospital Rio Hortega
  • Zamora, Spain, 49021
    • Hospital Provincial de Zamora
  • Zaragoza, Spain, 50009
    • Hospital Miguel Servet
  • Alicante
    • Alcoy, Alicante, Spain, 03804
      • Hospital de Alcoy Virgen de los Lirios
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Central Universitario de Asturias
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07198
      • Hospital Son Llatzer
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Igualada, Barcelona, Spain, 08700
      • Hospital de Igualada
    • Terrassa, Barcelona, Spain, 08221
      • Mutua de Terrassa
  • Cádiz
    • Algeciras, Cádiz, Spain, 11207
      • Hospital Punta de Europa
    • Jerez de la Frontera, Cádiz, Spain, 11404
      • Hospital de Jerez
  • Guipúzcoa
    • San Sebastián, Guipúzcoa, Spain, 20014
      • Hospital de Donostia
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Hospital Principe de Asturias
    • Getafe, Madrid, Spain, 28901
      • Hospital de Getafe
    • Leganés, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Quirón
  • Málaga
    • Ronda, Málaga, Spain, 29400
      • Hospital Serranía de Ronda
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Hospital Universitario Nuestra Señora de la Candelaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with disseminated breast cancer, HER-2 3+ or FISH+.

Description

Inclusion Criteria:

1. Women older than 18.
2. Patients with disseminated breast cancer with overexpression of HER-2 (IHC 3 + or FISH +).
3. Patients who have been treated with trastuzumab (Herceptin ®).
4. Complete remission, partial or stable disease for a period exceeding 3 years, except for exclusive cerebral progression.
5. Patients who have given their written informed consent.

Exclusion Criteria:

1- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Collaborators and Investigators

• Sponsor: Asociación para el Progreso de la Oncología en Málaga
• Collaborators: Roche Farma, S.A
• Investigators: Study Chair: Emilio Alba, Hospital Virgen de la Victoria

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Estimate): September 14, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Breast cancer.; Trastuzumab.; Complete remission.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LongHer