Trastuzumab or Lapatinib
DrugAnti-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.
NCT Number: NCT01077648
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.
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Notify Me30 year and older
Female
Observational
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
Time frame: Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)
Time frame: Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis
Time frame: Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)
GlaxoSmithKline
Industry
Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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