Lapatinib Resistance in Patients With Breast Cancer
Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
- To investigate ErbB2 copy number changes and expression levels.
- To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.
研究の種類
連絡先と場所
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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Cleveland、Ohio、アメリカ、44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Cleveland、Ohio、アメリカ、44024
- Geauga Regional Hospital
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Cleveland、Ohio、アメリカ、44060
- Lake/University Ireland Cancer Center
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Cleveland、Ohio、アメリカ、44121
- University Suburban Health Center
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Cleveland、Ohio、アメリカ、44122
- UHHS Chagrin Highlands Medical Center
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Cleveland、Ohio、アメリカ、44130
- Southwest General Health Center
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Cleveland、Ohio、アメリカ、44145
- UHHS Westlake Medical Center
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Cleveland、Ohio、アメリカ、44708
- Mercy Cancer Center at Mercy Medical Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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
DISEASE CHARACTERISTICS:
Pathologically confirmed invasive breast cancer
- ErbB2-positive disease
Has received or is currently receiving lapatinib ditosylate
- Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
- Must have tumor tissue samples available for research studies
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant*
- Coagulation profile normal*
- Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
- No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
- No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy
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
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 |
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Secondary ErbB2 mutations
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ErbB2 copy number changes and expression levels
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Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance
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協力者と研究者
捜査官
- 主任研究者：Balazs Halmos, MD、Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始
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。