Disseminated HER2+ Breast CancerPRIMHERNCT01645059
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
An observational study of Disseminated HER2+ Breast Cancer, run by Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica at 39 sites in Spain.
Trial summary
This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Disseminated HER2+ Breast Cancer
- How many people
- 129 participants
- Where
- 39 sitesSpain
- Study dates
- Jul 2011to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Female patients with disseminated HER2+ breast cancer in first line treatment
Who may be able to join
- Women with 18 years or over
- Patients with disseminated breast cancer histologically or cytological confirmed, who begins with Her 2+ metastatic breast cancer or develops a metastasis after or during the adjuvant therapy
- Patients treated in first line treatment in metastatic disease.
- Patients who have positive Her 2 receptor test
- Patients who have given their written informed consent
Who cannot join
- Patients who are participating in other studies
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Spain39 sites
Hospital de Alcañiz
Alcañiz, Teruel, 44600
Hospital de Torrecárdenas
Almería, Almería, 04009
Hospital Infanta Cristina de Badajoz
Badajoz, Badajoz, 06008
ICO Badalona
Badalona, Barcelona, 08916
Clínica Corachan
Barcelona, Barcelona, 08017
Hospital San Pedro Alcántara
Cáceres, Cáceres, 10003
Complejo Hospitalario Ciudad Real
Ciudad Real, Ciudad Real, 13005
Hospital de Denia
Denia, Alicante, 03700
Hospital don Benito
Don Benito, Badajoz, 06400
Hospital General de Elda
Elda, Alicante, 03600
Hospital de Galdakao
Galdakao, Vizcaya, 48960
Hospital de Getafe
Getafe, Madrid, 28901
Hospital de Cabueñes
Gijón, Principality of Asturias, 33203
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11404
Hospital General de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital de León
León, León, 24008
Hospital Universitario Arnau de Vilanova
Lleida, Lleida, 25198
Hospital de Llerena
Llerena, Badajoz, 06900
Hospital Lucus Augusti
Lugo, Lugo, 27003
Hospital La Princesa
Madrid, Madrid, 28006
Hospital de Mérida
Mérida, Badajoz, 06800
Hospital de Móstoles
Móstoles, Madrid, 28935
Hospital Morales Messeguer
Murcia, Murcia, 30008
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Virgen del Puerto
Plasencia, Cáceres, 10600
Hospital Quirón
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario de la Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital General de Segovia
Segovia, Segovia, 40002
Hospital Virgen de la Macarena
Seville, Sevilla, 41009
Hospital Reina Sofía de Tudela
Tudela, Navarre, 31500
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Dr.Peset
Valencia, Valencia, 46017
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47005
Hospital Universitario Rio Hortega
Valladolid, Valladolid, 47012
Hospital do Meixoeiro
Vigo, Pontevedra, 36214
Hospital de Txagorritxu
Vitoria-Gasteiz, Álava, 01009
Hospital de Zamora
Zamora, Zamora, 49021
About this study
Official title: Observational, Cross-sectional, 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 (PRIMHER)
This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment.
- Conditions
- Disseminated HER2+ Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis
Measured: 1 day (there is no follow-up, it is a cross-sectional study)
Secondary outcomes (8)
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Measured: one day (there is no follow-up, it is a cross-sectional study)
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Measured: one day (there is no follow-up, it si a cross-sectional study)
Adjuvant Treatment and Age
Adjuvant treatment and clinical profile (age)
The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
Measured: one day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment-Physical Activity
Adjuvant treatment and clinical profile (Physical activity)
The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
Measured: one day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment-Node Affectation
Adjuvant treatment and clinical profile (Node affectation)
The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)
Measured: one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-Age
Analyse disseminated Breast Cancer treatment and clinical profile (age)
Measured: one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-physical Activity
Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
Measured: one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-Smoking
Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
Measured: one day (there is no follow-up, it is a cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disseminated HER2+ 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mª Helena López Ceballos, MD, Principal investigator, Hospital San Pedro AlcántaraSantiago González Santiago, MD, Principal investigator, Hospital San Pedro Alcántara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645059
- Sponsor's protocol ID
- ACI-CMM-2010-01
- Acronym
- PRIMHER
- Status last verified
- Nov 2013
- First submitted
- 13 Jul 2012
- Last updated
- 8 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Cross-sectional, 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 (PRIMHER)
- ClinicalTrials.gov ID
- NCT01645059
- Acronym / sponsor ID
- PRIMHER / ACI-CMM-2010-01
- Conditions
- Disseminated HER2+ Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Asociación Cacereña para la Investigación y el Desarrollo en Oncología MédicaResearch network
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 8 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment.
Study design
- Observational model
- Cohort
- 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
- Female patients with disseminated HER2+ breast cancer in first line treatment
Key inclusion criteria (5 listed)
- Women with 18 years or over
- Patients with disseminated breast cancer histologically or cytological confirmed, who begins with Her 2+ metastatic breast cancer or develops a metastasis after or during the adjuvant therapy
- Patients treated in first line treatment in metastatic disease.
- Patients who have positive Her 2 receptor test
- Patients who have given their written informed consent
Key exclusion criteria (1 listed)
- Patients who are participating in other studies
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
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Time frame: 1 day (there is no follow-up, it is a cross-sectional study)
General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis
8 secondary outcomes
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Time frame: one day (there is no follow-up, it is a cross-sectional study)
The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Time frame: one day (there is no follow-up, it si a cross-sectional study)
Adjuvant Treatment and Age
Time frame: one day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment-Physical Activity
Time frame: one day (there is no follow-up, it is a cross-sectional study)
Adjuvant Treatment-Node Affectation
Time frame: one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-Age
Time frame: one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-physical Activity
Time frame: one day (there is no follow-up, it is a cross-sectional study)
Disseminated Breast Cancer Treatment-Smoking
Time frame: one day (there is no follow-up, it is a cross-sectional study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Disseminated HER2+ Breast Cancer
RecruitingPhase 1/2
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)
Breast, Metastatic
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.
Mª Helena López Ceballos, MD principal investigator
Hospital San Pedro Alcántara
Santiago González Santiago, MD principal investigator
Hospital San Pedro Alcántara
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 Disseminated HER2+ Breast Cancer, run by Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica 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 8 Jan 2014. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics) (time frame: 1 day (there is no follow-up, it is a cross-sectional study)). It is what the study was designed to measure, not a finding.
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 8 Jan 2014.