Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in HR+ Breast Cancer Patients
2016年6月21日 更新者：Tianjin Medical University Cancer Institute and Hospital
Retrospective Analysis of Effectiveness and Safety Profile of Anastrozole and Letrozole in Adjuvant Treatment of HR+ Early Breast Cancer Patients
This is a single centre, observational and retrospective clinical study.
The study group was about all HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up data.
調査の概要
詳細な説明
The department of surgery at Tian Jin Medical University Cancer Hospital, one of the centers of excellence to treat patients with breast cancer in China, collects and maintains an electronic database of patients treatment details and follow up data.
This is a single centre, observational and retrospective clinical study.
The study group was about all HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted AI therapy with the completed follow-up data.All the enrolled patients received breast-conserving surgery or whole breast surgery, and afterwards, received adjuvant chemotherapy according the pathological types.
The patient's clinical pathological data include the age, family history, surgery options, pathologic type, the size of tumor, lymph node status, histological grade, chemotherapy regime, irradiation regime, and the expressions pattern of Her-2 and Ki-67.
The research starts when the patients received the first time AI treatment.
In the subsequent treatment, we analyzed the patients' bone density changes (T value >-1 indicates normal,-2.5≤T
value≤-1 indicates mild osteoporosis, T value <-2.5 indicates severe osteoporosis) each half year for 3 years, analyzed the patients' liver function and kidney function changes each half year for 3 years (AST, ALT, ALP, TBIL, DBIL,UREA and CREA values > 2 times ULN indicates abnormal), analyzed the patients' blood-lipoids (LDL, HDL, TG and TC) each half year for 3 years, the occurrence rates of adverse reactions (skin flush, joint pain, headache, rash, nausea, vomiting, diarrhea, et al), the causes and rates of treatment termination between the 2 groups, the 3 years DFS and OS between two groups, and the factors associated with survival and prognosis, and identified the benefit individuals of AI therapy.
研究の種類
観察的
入学 (予想される)
1000
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
サンプリング方法
確率サンプル
調査対象母集団
This is a single centre, observational and retrospective clinical study.The study group was about all HR positive postmenopausal breast cancer patients,and ever accepted AI therapy with the completed follow-up data.
The patient's clinical pathological data include the age, family history, surgery options, pathologic type,et al.
We analyzed the patients' bone density changes, liver function and kidney function changes,and analyzed the patients' blood-lipoids each half year for 3 years, the occurrence rates of adverse reactions, the causes and rates of treatment termination between the 2 groups, the 3 years DFS and OS between two groups, and the factors associated with survival and prognosis, and identified the benefit individuals of AI therapy.
説明
Inclusion Criteria:
1). Breast cancer confirmed by histology or cytology with the tumor complete resection 2). ER and /or PR positive 3). Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]):
- Prior bilateral oophorectomy;
- Age ≥ 60 years;
Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and plasma FSH and estradiol in the postmenopausal range; if taking tamoxifen or toremifene, and age<60 years, then serial measurement of plasma FSH and estradiol are need to ensure in the postmenopausal ranges.
4). Patients have received regular anastrozole or letrozole adjuvant treatment 6). The values of AST, ALT, ALP, TBIL, UREA, CREA were less than 2 times of ULN at the beginning of AI therapy.
7). BMD T >-1 at baseline.
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
- . Previous use of the other AIs except for anastrozole or letrozole
- . Any severe concomitant condition before AI treatment: uncontrolled cardiac disease or uncontrolled diabetes mellitus et al.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|
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Anastrozole treatment group
The study group was about HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted anastrozole therapy with the completed follow-up data.
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letrozole treatment group
The study group was about HR positive postmenopausal breast cancer patients who were hospitalized between January, 2008 and October, 2010, and ever accepted letrozole therapy with the completed follow-up data.
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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 |
|---|---|
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Compare the proportion of patients with abnormal biochemical test results including liver function, kidney function, blood-lipoids, bone density index.
時間枠：one year
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one year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To explore the proportion of patients discontinue AI treatment and reasons related to these discontinuation.
時間枠：one year
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one year
|
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To explore the 3-year DFS rate among the people under upfront therapy.
時間枠：one year
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one year
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To explore the 3-year OS rate among the people under upfront therapy.
時間枠：one year
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one year
|
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To explore the DFS in the patients who quit treating.
時間枠：one year
|
one year
|
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To explore the OS in the patients who quit treating.
時間枠：one year
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one year
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年7月1日
一次修了 (予想される)
2017年7月1日
研究の完了 (予想される)
2017年11月1日
試験登録日
最初に提出
2016年5月15日
QC基準を満たした最初の提出物
2016年6月21日
最初の投稿 (見積もり)
2016年6月24日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年6月24日
QC基準を満たした最後の更新が送信されました
2016年6月21日
最終確認日
2016年4月1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。