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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
129
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Almería, Spania, 04009
- Hospital de Torrecardenas
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Badajoz, Spania, 06008
- Hospital Infanta Cristina de Badajoz
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Barcelona, Spania, 08017
- Clínica Corachan
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Ciudad Real, Spania, 13005
- Complejo Hospitalario Ciudad Real
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Cáceres, Spania, 10003
- Hospital San Pedro Alcántara
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León, Spania, 24008
- Hospital de León
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Lleida, Spania, 25198
- Hospital Universitario Arnau de Vilanova
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Lugo, Spania, 27003
- Hospital Lucus Augusti
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Madrid, Spania, 28006
- Hospital La Princesa
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Murcia, Spania, 30008
- Hospital Morales Messeguer
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Segovia, Spania, 40002
- Hospital General de Segovia
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Sevilla, Spania, 41009
- Hospital Virgen de la Macarena
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Valencia, Spania, 46014
- Hospital General Universitario de Valencia
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Valencia, Spania, 46017
- Hospital Dr.Peset
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Valladolid, Spania, 47012
- Hospital Universitario Río Hortega
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Valladolid, Spania, 47005
- Hospital Clínico de Valladolid
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Zamora, Spania, 49021
- Hospital de Zamora
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Alicante
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Denia, Alicante, Spania, 03700
- Hospital de Denia
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Elda, Alicante, Spania, 03600
- Hospital General de Elda
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Asturias
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Gijón, Asturias, Spania, 33203
- Hospital de Cabueñes
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Badajoz
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Don Benito, Badajoz, Spania, 06400
- Hospital don Benito
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Llerena, Badajoz, Spania, 06900
- Hospital de Llerena
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Mérida, Badajoz, Spania, 06800
- Hospital de Mérida
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Ico Badalona
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Hospitalet de Llobregat, Barcelona, Spania, 08906
- Hospital General de l'Hospitalet
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Cáceres
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Plasencia, Cáceres, Spania, 10600
- Hospital Virgen Del Puerto
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Cádiz
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Jerez de la Frontera, Cádiz, Spania, 11404
- Hospital de Jerez
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spania, 07198
- Hospital Son Llatzer
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Madrid
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Getafe, Madrid, Spania, 28901
- Hospital de Getafe
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Leganés, Madrid, Spania, 28911
- Hospital Severo Ochoa
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Móstoles, Madrid, Spania, 28935
- Hospital De Mostoles
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Pozuelo de Alarcón, Madrid, Spania, 28223
- Hospital Quirón
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Navarra
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Tudela, Navarra, Spania, 31500
- Hospital Reina Sofía de Tudela
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Pontevedra
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Vigo, Pontevedra, Spania, 36214
- Hospital Do Meixoeiro
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Tenerife
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La Laguna, Tenerife, Spania, 38320
- Hospital Universitario de Canarias
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Santa Cruz de Tenerife, Tenerife, Spania, 38010
- Hospital Universitario de la Candelaria
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Teruel
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Alcañiz, Teruel, Spania, 44600
- Hospital de Alcañiz
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Vizcaya
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Galdakao, Vizcaya, Spania, 48960
- Hospital de Galdakao
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Álava
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Vitoria, Álava, Spania, 01009
- Hospital de Txagorritxu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
|
|
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)
|
|
|
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)
|
Analyse disseminated Breast Cancer treatment and clinical profile (age)
|
one day (there is no follow-up, it is a cross-sectional study)
|
|
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)
|
|
Disseminated Breast Cancer Treatment-Smoking
Tidsramme: one day (there is no follow-up, it is a cross-sectional study)
|
Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)
|
one day (there is no follow-up, it is a cross-sectional study)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Mª Helena López Ceballos, MD, Hospital San Pedro Alcántara
- Hovedetterforsker: Santiago González Santiago, MD, Hospital San Pedro Alcántara
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2011
Primær fullføring (Faktiske)
1. mars 2013
Studiet fullført (Faktiske)
1. mars 2013
Datoer for studieregistrering
Først innsendt
13. juli 2012
Først innsendt som oppfylte QC-kriteriene
19. juli 2012
Først lagt ut (Anslag)
20. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. januar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. november 2013
Sist bekreftet
1. november 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACI-CMM-2010-01
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