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
NCT ID: NCT01433926
Last Updated: 2011-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
114 participants
OBSERVATIONAL
2009-09-30
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
NCT04578106
Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy
NCT01645059
Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer
NCT03595592
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
NCT00337649
A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
NCT01940497
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roche Farma, S.A
INDUSTRY
Asociación para el Progreso de la Oncología en Málaga
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emilio Alba
Role: STUDY_CHAIR
Hospital Virgen de la Victoria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital oncológico de Galicia
A Coruña, A Coruña, Spain
Hospital de Alcoy Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Pau
Barcelona, Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Barcelona, Spain
Hospital de Igualada
Igualada, Barcelona, Spain
Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital General Yagüe
Burgos, Burgos, Spain
Hospital San Pedro de Alcántara
Cáceres, Cáceres, Spain
Hospital Punta de Europa
Algeciras, Cádiz, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Hospital Clínico San Cecilio
Granada, Granada, Spain
Hospital Virgen de las Nieves
Granada, Granada, Spain
Hospital de Guadalajara
Guadalajara, Guadalajara, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, Spain
Hospital Juan Ramón Jiménez
Huelva, Huelva, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital de Getafe
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
MD Anderson
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hsopital Doce de Octubre
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Quirón
Pozuelo de Alarcón, Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Serranía de Ronda
Ronda, Málaga, Spain
Hospital Central Universitario de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Nuestra Señora De Valme
Seville, Sevilla, Spain
Hospital Virgen del Rocío
Seville, Sevilla, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital La Fe
Valencia, Valencia, Spain
Hospital Río Hortega
Valladolid, Valladolid, Spain
Hospital Provincial de Zamora
Zamora, Zamora, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LongHer
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.