- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01645059
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)
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)
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Almería, Spagna, 04009
- Hospital de Torrecárdenas
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Badajoz, Spagna, 06008
- Hospital Infanta Cristina de Badajoz
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Barcelona, Spagna, 08017
- Clinica Corachan
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Ciudad Real, Spagna, 13005
- Complejo Hospitalario Ciudad Real
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Cáceres, Spagna, 10003
- Hospital San Pedro Alcántara
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León, Spagna, 24008
- Hospital de Leon
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Lleida, Spagna, 25198
- Hospital Universitario Arnau de Vilanova
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Lugo, Spagna, 27003
- Hospital Lucus Augusti
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Madrid, Spagna, 28006
- Hospital La Princesa
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Murcia, Spagna, 30008
- Hospital Morales Messeguer
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Segovia, Spagna, 40002
- Hospital General de Segovia
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Sevilla, Spagna, 41009
- Hospital Virgen de la Macarena
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Valencia, Spagna, 46014
- Hospital General Universitario de Valencia
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Valencia, Spagna, 46017
- Hospital Dr.Peset
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Valladolid, Spagna, 47012
- Hospital Universitario Río Hortega
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Valladolid, Spagna, 47005
- Hospital Clínico de Valladolid
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Zamora, Spagna, 49021
- Hospital de Zamora
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Alicante
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Denia, Alicante, Spagna, 03700
- Hospital de Denia
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Elda, Alicante, Spagna, 03600
- Hospital General de Elda
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Asturias
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Gijón, Asturias, Spagna, 33203
- Hospital de Cabueñes
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Badajoz
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Don Benito, Badajoz, Spagna, 06400
- Hospital don Benito
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Llerena, Badajoz, Spagna, 06900
- Hospital de Llerena
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Mérida, Badajoz, Spagna, 06800
- Hospital de Mérida
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Barcelona
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Badalona, Barcelona, Spagna, 08916
- Ico Badalona
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Hospitalet de Llobregat, Barcelona, Spagna, 08906
- Hospital General de l'Hospitalet
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Cáceres
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Plasencia, Cáceres, Spagna, 10600
- Hospital Virgen del Puerto
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Cádiz
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Jerez de la Frontera, Cádiz, Spagna, 11404
- Hospital de Jerez
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spagna, 07198
- Hospital Son Llatzer
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Madrid
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Getafe, Madrid, Spagna, 28901
- Hospital de Getafe
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Leganés, Madrid, Spagna, 28911
- Hospital Severo Ochoa
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Móstoles, Madrid, Spagna, 28935
- Hospital De Mostoles
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Pozuelo de Alarcón, Madrid, Spagna, 28223
- Hospital Quirón
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Navarra
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Tudela, Navarra, Spagna, 31500
- Hospital Reina Sofía de Tudela
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Pontevedra
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Vigo, Pontevedra, Spagna, 36214
- Hospital Do Meixoeiro
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Tenerife
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La Laguna, Tenerife, Spagna, 38320
- Hospital Universitario de Canarias
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Santa Cruz de Tenerife, Tenerife, Spagna, 38010
- Hospital Universitario de la Candelaria
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Teruel
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Alcañiz, Teruel, Spagna, 44600
- Hospital de Alcañiz
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Vizcaya
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Galdakao, Vizcaya, Spagna, 48960
- Hospital de Galdakao
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Álava
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Vitoria, Álava, Spagna, 01009
- Hospital de Txagorritxu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who are participating in other studies
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Lasso di tempo: 1 day (there is no follow-up, it is a cross-sectional study)
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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
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1 day (there is no follow-up, it is a cross-sectional study)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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one day (there is no follow-up, it is a cross-sectional study)
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The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy
Lasso di tempo: one day (there is no follow-up, it si a cross-sectional study)
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one day (there is no follow-up, it si a cross-sectional study)
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Adjuvant Treatment and Age
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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Adjuvant treatment and clinical profile (age) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) |
one day (there is no follow-up, it is a cross-sectional study)
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Adjuvant Treatment-Physical Activity
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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Adjuvant treatment and clinical profile (Physical activity) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) |
one day (there is no follow-up, it is a cross-sectional study)
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Adjuvant Treatment-Node Affectation
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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Adjuvant treatment and clinical profile (Node affectation) The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66) |
one day (there is no follow-up, it is a cross-sectional study)
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Disseminated Breast Cancer Treatment-Age
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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Analyse disseminated Breast Cancer treatment and clinical profile (age)
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one day (there is no follow-up, it is a cross-sectional study)
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Disseminated Breast Cancer Treatment-physical Activity
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
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one day (there is no follow-up, it is a cross-sectional study)
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Disseminated Breast Cancer Treatment-Smoking
Lasso di tempo: one day (there is no follow-up, it is a cross-sectional study)
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Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
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one day (there is no follow-up, it is a cross-sectional study)
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Mª Helena López Ceballos, MD, Hospital San Pedro Alcántara
- Investigatore principale: Santiago González Santiago, MD, Hospital San Pedro Alcántara
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ACI-CMM-2010-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Disseminated HER2+ Breast Cancer
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Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
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NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di