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
1 other identifier
observational
114
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2009
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedSeptember 14, 2011
September 1, 2011
1.5 years
September 13, 2011
September 13, 2011
Conditions
Keywords
Eligibility Criteria
Women with disseminated breast cancer, HER-2 3+ or FISH+.
You may qualify if:
- Women older than 18.
- Patients with disseminated breast cancer with overexpression of HER-2 (IHC 3 + or FISH +).
- Patients who have been treated with trastuzumab (Herceptin ®).
- Complete remission, partial or stable disease for a period exceeding 3 years, except for exclusive cerebral progression.
- Patients who have given their written informed consent.
You may not qualify if:
- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Hospital oncológico de Galicia
A Coruña, A Coruña, 15003, Spain
Hospital de Alcoy Virgen de los Lirios
Alcoy, Alicante, 03804, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clinic i Provincial
Barcelona, Barcelona, 08036, Spain
Hospital de Igualada
Igualada, Barcelona, 08700, Spain
Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital General Yagüe
Burgos, Burgos, 09005, Spain
Hospital San Pedro de Alcántara
Cáceres, Cáceres, 10003, Spain
Hospital Punta de Europa
Algeciras, Cádiz, 11207, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11404, Spain
Hospital Clínico San Cecilio
Granada, Granada, 18012, Spain
Hospital Virgen de las Nieves
Granada, Granada, 18014, Spain
Hospital de Guadalajara
Guadalajara, Guadalajara, 19002, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014, Spain
Hospital Juan Ramón Jiménez
Huelva, Huelva, 21005, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital de Getafe
Getafe, Madrid, 28901, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911, Spain
MD Anderson
Madrid, Madrid, 28033, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hsopital Doce de Octubre
Madrid, Madrid, 28041, Spain
Hospital La Paz
Madrid, Madrid, 28046, Spain
Hospital Quirón
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital Serranía de Ronda
Ronda, Málaga, 29400, Spain
Hospital Central Universitario de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007, Spain
Hospital Nuestra Señora De Valme
Seville, Sevilla, 41014, Spain
Hospital Virgen del Rocío
Seville, Sevilla, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Hospital La Fe
Valencia, Valencia, Spain
Hospital Río Hortega
Valladolid, Valladolid, 47012, Spain
Hospital Provincial de Zamora
Zamora, Zamora, 49021, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Biospecimen
primary tumor, preserved in paraffin
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Emilio Alba
Hospital Virgen de la Victoria
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 14, 2011
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
September 1, 2011
Last Updated
September 14, 2011
Record last verified: 2011-09