Brain Metastasis in Breast Cancer Patients
Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).
時間枠：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)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
時間枠：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).
時間枠：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)
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。