Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for HER2 Positive Early Breast Cancer Patients
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now.
Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a metheod for omitting chemotherapy for her2 positive participants.
調査の概要
状態
条件
詳細な説明
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with her2 enriched subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 positive patients include chemotherapy and targeted therapy. Although the pCR rate was high to 60% after use of trastuzumab and pertuzumab, but the adverse reaction of combined chemotherapy could not be negligible. Based on the application of dual targeted drugs, some studies have attempted chemotherapy-free treatment for her2 positive patients during neoadjuvant therapy. But, which patient could be exempted from chemotherapy and which drug could be omitted are still unknow before treatment. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer participants until now.
Previously, investigators developed a patient-derived tumor-like cell clusters(PTC) in vitro culture technology. It is a cell cluster including tumor cells, mesenchymal cells and lymphocytes, which simulates the tumor microenvironment in vitro. In the preliminary exploration, investigators included 35 early breast cancer participants, the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well. The results have been published.
This study will focus on her2 positive early breast cancer participants. 46 participants will be included. All of them will received in vitro drug sensitivity screenning upon PTC before neoadjuvant therapy. All participants will received trastuzumab and pertuzumab. The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results. If single-agent chemotherapy is effective in vitro, this drug will be the chemotherapy regimen for the corresponding participants. This study expects that the pCR rate could achieve 60% in the case of chemotherapy downgrading after in vitro drug sensitivity screening.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Chaobin Wang
- 電話番号：+86 010 88324010
- メール：hzwcb1990@163.com
研究場所
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Beijing
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Beijing、Beijing、中国、100044
- 募集
- Peking University People's Hospital
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コンタクト：
- CHAOBIN WANG, Doctor
- 電話番号：+86 010-88324010
- メール：hzwcb1990@163.com
-
-
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
説明
Inclusion Criteria:
- invasive breast cancer
- HER2 positive
- T2 or node positive
- ECOG 0-1
Exclusion Criteria:
- stage IV
- inflammatory breast cancer
- Severe chronic disease
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Neoadjuvant therapy base on PTC drug screenning
Patients will receive neoadjuvant therapy including trastuzumab, pertuzumab, and chemotherapy based on PTC drug screening.
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The choice of chemotherapy is based on the PTC drug sensitivity results.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
pathological complete response(pCR)
時間枠：up to 12 weeks
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ypT0/is, ypN0
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up to 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
イベントフリーサバイバル (EFS)
時間枠：5年
|
手術前の局所進行を含む、無作為割り当てから疾患進行までの時間。疾患の再発 - 局所、局所、遠隔、同側の非侵襲的、または対側（侵襲的または非侵襲的） - またはあらゆる原因による死亡
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5年
|
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invasive disease-free survival(IDFS)
時間枠：5 years
|
The time from surgery to the first documented occurrence of an event defined as ipsilateral invasive local recurrence, ipsilateral locoregional invasive recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause
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5 years
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objective response rate
時間枠：up to 12 weeks
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complete response and partial response
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up to 12 weeks
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協力者と研究者
捜査官
- 主任研究者：Shu Wang, doctor、Peking University People's Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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