Brain Metastasis in Breast Cancer Patients
22. mai 2014 oppdatert av: GlaxoSmithKline
Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease
The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.
Studieoversikt
Detaljert beskrivelse
A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.
Other secondary outcomes to be explored include:
- Survival after advanced breast cancer-time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
- Time to brain metastases-time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
- Survival after brain metastases-time in months from the date of diagnosis of brain metastases until death or end of study period
Studietype
Observasjonsmessig
Registrering (Faktiske)
1
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
30 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
This study aims to retrospectively collect data on nearly 4,000 advanced breast cancer cases treated within the Henry Ford Health System
Beskrivelse
Inclusion Criteria:
- Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
- At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
- Age 30 years or older at diagnosis.
Exclusion Criteria:
- Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
- Age less than 30 years or older at diagnosis.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Women diagnosed with advanced breast cancer
Women diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System
|
Anti-erbB2 therapy for breast cancer treatment will be analyzed as a class level variable; individual drugs including trastuzumab and lapatinib will also be explored as exposures if sufficient numbers of patients exist.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).
Tidsramme: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
|
Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Tidsramme: Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)
|
Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)
|
|
Time to brain metastases stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Tidsramme: Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis
|
Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis
|
|
Survival after brain metastases diagnosis, overall and stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only)
Tidsramme: Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)
|
Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. februar 2010
Primær fullføring (Faktiske)
1. august 2013
Studiet fullført (Faktiske)
1. august 2013
Datoer for studieregistrering
Først innsendt
25. februar 2010
Først innsendt som oppfylte QC-kriteriene
25. februar 2010
Først lagt ut (Anslag)
1. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplastiske prosesser
- Neoplasmer i sentralnervesystemet
- Neoplasmer i nervesystemet
- Neoplasma Metastase
- Neoplasmer i hjernen
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Proteinkinasehemmere
- Trastuzumab
- Lapatinib
Andre studie-ID-numre
- 112951
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