HER-2 Positive Breast CancerLongHerNCT01433926
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
An observational study of HER-2 Positive Breast Cancer, run by Asociación para el Progreso de la Oncología en Málaga at 39 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER-2 Positive Breast Cancer
- How many people
- 114 participants
- Where
- 39 sitesSpain
- Study dates
- Sep 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with disseminated breast cancer, HER-2 3+ or FISH+.
Who may be able to join
- 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.
Who cannot join
- 1- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Spain39 sites
Hospital oncológico de Galicia
A Coruña, A Coruña, 15003
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
Hospital de Alcoy Virgen de los Lirios
Alcoy, Alicante, 03804
Hospital Punta de Europa
Algeciras, Cádiz, 11207
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Sant Pau
Barcelona, Barcelona, 08025
Hospital Clinic i Provincial
Barcelona, Barcelona, 08036
Hospital General Yagüe
Burgos, Burgos, 09005
Hospital San Pedro de Alcántara
Cáceres, Cáceres, 10003
Hospital de Getafe
Getafe, Madrid, 28901
Hospital Clínico San Cecilio
Granada, Granada, 18012
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital de Guadalajara
Guadalajara, Guadalajara, 19002
Hospital Juan Ramón Jiménez
Huelva, Huelva, 21005
Hospital de Igualada
Igualada, Barcelona, 08700
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11404
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
MD Anderson
Madrid, Madrid, 28033
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hsopital Doce de Octubre
Madrid, Madrid, 28041
Hospital La Paz
Madrid, Madrid, 28046
Hospital Virgen de la Victoria
Málaga, Málaga, 29010
Hospital Central Universitario de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Quirón
Pozuelo de Alarcón, Madrid, 28223
Hospital Serranía de Ronda
Ronda, Málaga, 29400
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital Nuestra Señora De Valme
Seville, Sevilla, 41014
Hospital Virgen del Rocío
Seville, Sevilla
Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital La Fe
Valencia, Valencia
Hospital Río Hortega
Valladolid, Valladolid, 47012
Hospital Provincial de Zamora
Zamora, Zamora, 49021
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
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
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.
Read the 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.
- Conditions
- HER-2 Positive Breast Cancer
- Keywords
- Breast cancer., Trastuzumab., Complete remission.
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para el Progreso de la Oncología en Málaga
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Farma, S.A
- Responsible party
- Sponsor
- Investigators
- Emilio Alba, Study chair, Hospital Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433926
- Sponsor's protocol ID
- LongHer
- Acronym
- LongHer
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01433926
- Acronym / sponsor ID
- LongHer / LongHer
- Conditions
- HER-2 Positive Breast Cancer
- Keywords
- Breast cancer., Trastuzumab., Complete remission.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Asociación para el Progreso de la Oncología en MálagaUniversity, hospital or other
- Collaborators
- Roche Farma, S.A
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with disseminated breast cancer, HER-2 3+ or FISH+.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Alba study chair
Hospital Virgen de la Victoria
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER-2 Positive Breast Cancer, run by Asociación para el Progreso de la Oncología en Málaga at 39 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2011.