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)
20. november 2013 opdateret af: Asociación Cacereña para la Investigación y el Desarrollo en Oncología Médica
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
129
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Almería, Spanien, 04009
- Hospital de Torrecardenas
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Badajoz, Spanien, 06008
- Hospital Infanta Cristina de Badajoz
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Barcelona, Spanien, 08017
- Clínica Corachan
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Ciudad Real, Spanien, 13005
- Complejo Hospitalario Ciudad Real
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Cáceres, Spanien, 10003
- Hospital San Pedro Alcántara
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León, Spanien, 24008
- Hospital de Leon
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Lleida, Spanien, 25198
- Hospital Universitario Arnau de Vilanova
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Lugo, Spanien, 27003
- Hospital Lucus Augusti
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Madrid, Spanien, 28006
- Hospital La Princesa
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Murcia, Spanien, 30008
- Hospital Morales Messeguer
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Segovia, Spanien, 40002
- Hospital General de Segovia
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Sevilla, Spanien, 41009
- Hospital Virgen de la Macarena
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Valencia, Spanien, 46014
- Hospital General Universitario de Valencia
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Valencia, Spanien, 46017
- Hospital Dr.Peset
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Valladolid, Spanien, 47012
- Hospital Universitario Rio Hortega
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Valladolid, Spanien, 47005
- Hospital Clínico de Valladolid
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Zamora, Spanien, 49021
- Hospital de Zamora
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Alicante
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Denia, Alicante, Spanien, 03700
- Hospital de Denia
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Elda, Alicante, Spanien, 03600
- Hospital General de Elda
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Asturias
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Gijón, Asturias, Spanien, 33203
- Hospital de Cabuenes
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Badajoz
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Don Benito, Badajoz, Spanien, 06400
- Hospital don Benito
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Llerena, Badajoz, Spanien, 06900
- Hospital de Llerena
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Mérida, Badajoz, Spanien, 06800
- Hospital de Merida
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Ico Badalona
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Hospitalet de Llobregat, Barcelona, Spanien, 08906
- Hospital General de l'Hospitalet
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Cáceres
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Plasencia, Cáceres, Spanien, 10600
- Hospital Virgen Del Puerto
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Cádiz
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Jerez de la Frontera, Cádiz, Spanien, 11404
- Hospital de Jerez
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spanien, 07198
- Hospital Son Llàtzer
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Madrid
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Getafe, Madrid, Spanien, 28901
- Hospital de Getafe
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Leganés, Madrid, Spanien, 28911
- Hospital Severo Ochoa
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Móstoles, Madrid, Spanien, 28935
- Hospital De Mostoles
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- Hospital Quirón
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Navarra
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Tudela, Navarra, Spanien, 31500
- Hospital Reina Sofía de Tudela
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Pontevedra
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Vigo, Pontevedra, Spanien, 36214
- Hospital Do Meixoeiro
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Tenerife
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La Laguna, Tenerife, Spanien, 38320
- Hospital Universitario de Canarias
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Santa Cruz de Tenerife, Tenerife, Spanien, 38010
- Hospital Universitario de la Candelaria
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Teruel
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Alcañiz, Teruel, Spanien, 44600
- Hospital de Alcañiz
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Vizcaya
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Galdakao, Vizcaya, Spanien, 48960
- Hospital de Galdakao
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Álava
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Vitoria, Álava, Spanien, 01009
- Hospital de Txagorritxu
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Female patients with disseminated HER2+ breast cancer in first line treatment
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
Tidsramme: 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
|
1 day (there is no follow-up, it is a cross-sectional study)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy
Tidsramme: one day (there is no follow-up, it is a cross-sectional study)
|
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
Tidsramme: one day (there is no follow-up, it si a cross-sectional study)
|
one day (there is no follow-up, it si a cross-sectional study)
|
|
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Adjuvant Treatment and Age
Tidsramme: one day (there is no follow-up, it is a cross-sectional study)
|
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)
|
|
Adjuvant Treatment-Physical Activity
Tidsramme: one day (there is no follow-up, it is a cross-sectional study)
|
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)
|
|
Adjuvant Treatment-Node Affectation
Tidsramme: one day (there is no follow-up, it is a cross-sectional study)
|
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)
|
|
Disseminated Breast Cancer Treatment-Age
Tidsramme: 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)
|
one day (there is no follow-up, it is a cross-sectional study)
|
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Disseminated Breast Cancer Treatment-physical Activity
Tidsramme: one day (there is no follow-up, it is a cross-sectional study)
|
Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)
|
one day (there is no follow-up, it is a cross-sectional study)
|
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Disseminated Breast Cancer Treatment-Smoking
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Mª Helena López Ceballos, MD, Hospital San Pedro Alcántara
- Ledende efterforsker: Santiago González Santiago, MD, Hospital San Pedro Alcántara
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2011
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
13. juli 2012
Først indsendt, der opfyldte QC-kriterier
19. juli 2012
Først opslået (Skøn)
20. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. november 2013
Sidst verificeret
1. november 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACI-CMM-2010-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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