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)

This study has been completed.
Sponsor:
Collaborator:
Roche Farma, S.A
Information provided by (Responsible Party):
Asociación para el Progreso de la Oncología en Málaga
ClinicalTrials.gov Identifier:
NCT01433926
First received: September 13, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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.


Condition
HER-2 Positive Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Asociación para el Progreso de la Oncología en Málaga:

Biospecimen Retention:   Samples With DNA

primary tumor, preserved in paraffin


Enrollment: 114
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433926

Locations
Spain
Hospital de Alcoy Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
Hospital Central Universitario de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Son Llatzer
Palma de Mallorca, Baleares, Spain, 07198
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital de Igualada
Igualada, Barcelona, Spain, 08700
Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Punta de Europa
Algeciras, Cádiz, Spain, 11207
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain, 11404
Hospital de Donostia
San Sebastián, Guipúzcoa, Spain, 20014
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Hospital de Getafe
Getafe, Madrid, Spain, 28901
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital Quirón
Pozuelo de Alarcón, Madrid, Spain, 28223
Hospital Serranía de Ronda
Ronda, Málaga, Spain, 29400
Hospital Universitario de Canarias
La Laguna, Tenerife, Spain, 38320
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital oncológico de Galicia
A Coruña, Spain, 15003
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Sant Pau
Barcelona, Spain, 08025
Hospital General Yagüe
Burgos, Spain, 09005
Hospital San Pedro de Alcántara
Cáceres, Spain, 10003
Hospital Clínico San Cecilio
Granada, Spain, 18012
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital de Guadalajara
Guadalajara, Spain, 19002
Hospital Juan Ramón Jiménez
Huelva, Spain, 21005
Hospital La Paz
Madrid, Spain, 28046
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Ramón y Cajal
Madrid, Spain, 28034
MD Anderson
Madrid, Spain, 28033
Hsopital Doce de Octubre
Madrid, Spain, 28041
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Nuestra Señora De Valme
Sevilla, Spain, 41014
Hospital Virgen del Rocío
Sevilla, Spain
Hospital La Fe
Valencia, Spain
Hospital Río Hortega
Valladolid, Spain, 47012
Hospital Provincial de Zamora
Zamora, Spain, 49021
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Asociación para el Progreso de la Oncología en Málaga
Roche Farma, S.A
Investigators
Study Chair: Emilio Alba Hospital Virgen de la Victoria
  More Information

No publications provided

Responsible Party: Asociación para el Progreso de la Oncología en Málaga
ClinicalTrials.gov Identifier: NCT01433926     History of Changes
Other Study ID Numbers: LongHer
Study First Received: September 13, 2011
Last Updated: September 13, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Asociación para el Progreso de la Oncología en Málaga:
Breast cancer.
Trastuzumab.
Complete remission.

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014