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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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 ID: NCT01433926

Interventions

Study Description

Brief Summary: 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.

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Hospital de Alcoy Virgen de los Lirios, Alcoy, Alicante, Spain

Hospital Central Universitario de Asturias, Oviedo, Asturias, Spain

Hospital Son Llatzer, Palma de Mallorca, Baleares, Spain

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Hospital de Igualada, Igualada, Barcelona, Spain

Mutua de Terrassa, Terrassa, Barcelona, Spain

Hospital Punta de Europa, Algeciras, Cádiz, Spain

Hospital de Jerez, Jerez de la Frontera, Cádiz, Spain

Hospital de Donostia, San Sebastián, Guipúzcoa, Spain

Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain

Hospital de Getafe, Getafe, Madrid, Spain

Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain

Hospital Quirón, Pozuelo de Alarcón, Madrid, Spain

Hospital Serranía de Ronda, Ronda, Málaga, Spain

Hospital Universitario de Canarias, La Laguna, Tenerife, Spain

Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Tenerife, Spain

Hospital oncológico de Galicia, A Coruña, , Spain

Hospital Sant Pau, Barcelona, , Spain

Hospital Clinic i Provincial, Barcelona, , Spain

Hospital General Yagüe, Burgos, , Spain

Hospital San Pedro de Alcántara, Cáceres, , Spain

Hospital Clínico San Cecilio, Granada, , Spain

Hospital Virgen de las Nieves, Granada, , Spain

Hospital de Guadalajara, Guadalajara, , Spain

Hospital Juan Ramón Jiménez, Huelva, , Spain

MD Anderson, Madrid, , Spain

Hospital Ramón y Cajal, Madrid, , Spain

Fundación Jiménez Díaz, Madrid, , Spain

Hospital Clínico San Carlos, Madrid, , Spain

Hsopital Doce de Octubre, Madrid, , Spain

Hospital La Paz, Madrid, , Spain

Hospital Virgen de la Victoria, Málaga, , Spain

Hospital Universitario de Salamanca, Salamanca, , Spain

Hospital Nuestra Señora De Valme, Sevilla, , Spain

Hospital Virgen del Rocío, Sevilla, , Spain

Hospital La Fe, Valencia, , Spain

Hospital Río Hortega, Valladolid, , Spain

Hospital Provincial de Zamora, Zamora, , Spain

Hospital Miguel Servet, Zaragoza, , Spain

Contact Details

Name: Emilio Alba

Affiliation: Hospital Virgen de la Victoria

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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