Brain Metastasis in Breast Cancer Patients
22. maj 2014 opdateret af: 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.
Studieoversigt
Detaljeret 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
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1
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
30 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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.
|
Hvad måler undersøgelsen?
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2010
Primær færdiggørelse (Faktiske)
1. august 2013
Studieafslutning (Faktiske)
1. august 2013
Datoer for studieregistrering
Først indsendt
25. februar 2010
Først indsendt, der opfyldte QC-kriterier
25. februar 2010
Først opslået (Skøn)
1. marts 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer
- Neoplasmer efter sted
- Neoplastiske processer
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Neoplasma Metastase
- Neoplasmer i hjernen
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Proteinkinasehæmmere
- Trastuzumab
- Lapatinib
Andre undersøgelses-id-numre
- 112951
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