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)
|ClinicalTrials.gov Identifier: NCT01433926|
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
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 or disease|
|HER-2 Positive Breast Cancer|
- 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|
|Actual Enrollment :||114 participants|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||September 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433926
|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|
|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 Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Clinic i Provincial|
|Barcelona, Spain, 08036|
|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|
|Madrid, Spain, 28033|
|Hospital Ramón y Cajal|
|Madrid, Spain, 28034|
|Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hsopital Doce de Octubre|
|Madrid, Spain, 28041|
|Hospital La Paz|
|Madrid, Spain, 28046|
|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|
|Hospital La Fe|
|Hospital Río Hortega|
|Valladolid, Spain, 47012|
|Hospital Provincial de Zamora|
|Zamora, Spain, 49021|
|Hospital Miguel Servet|
|Zaragoza, Spain, 50009|
|Study Chair:||Emilio Alba||Hospital Virgen de la Victoria|