Anlotinib in Metastatic HER2 Negative Breast Cancer
The Efficacy and Safety of Anlotinib in Metastatic HER2 Negative Breast Cancer, a Single Arm Phase II Clinical Trial
調査の概要
詳細な説明
Breast cancer is one of the most common malignant tumors in women, which is a serious threat to women's health. Despite the continuous improvement of treatment, 30% of breast cancer eventually develops into advanced breast cancer. The median survival of advanced breast cancer after routine treatment is 2-3 years. The main treatments include chemotherapy, endocrine therapy, and targeted therapy. The treatment of metastatic breast cancer (MBC) aims to improve quality of life, reduce pain and prolong survival.
Angiogenesis plays an important role in tumor cell proliferation and metastasis. Various anti-angiogenic drugs such as bevacizumab, sunitinib, sorafenib, etc. have been developed and widely used in various tumors. Treatments such as colon cancer, lung cancer, and renal cell carcinoma significantly improve PFS and OS in patients with advanced disease, and the adverse reactions are well tolerated. However, anti-angiogenic therapy has certain limitations in the treatment of advanced breast cancer.
Anrotinib hydrochloride capsule is a new drug independently developed in China. It is a multi-target receptor tyrosine kinase inhibitor targeting angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3 and other kinases such as cell growth-related kinases such as PDGFRα/β, c-Kit, and Ret , and it was approved by China Food and Drug Administation for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have progressed or relapsed after receiving at least 2 systemic chemotherapy. Basic research shows that anlotinib is effective in breast cancer cell lines, but lacks the results of clinical application of advanced breast cancer. This study is based on the results of phase I clinical trials of allerinib in a variety of advanced solid tumors, to explore its efficacy and safety in HER2-negative advanced breast cancer.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100021
- National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
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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:
- Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);
- ECOG score: 0-1, expected survival time ≥ 3months;
- Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-2 standard chemotherapies after recurrence and metastasis;
- According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm,other examination >2cm);
- The patients have enough organ function. The laboratory test indexes must comply with the following requirements:
Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance >50ml/min(Cockcroft-Gault formula)
- Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration;
- Can swallow oral drugs;
- The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
Exclusion Criteria:
- The patients in pregnancy or lactation growth period and did not take effective contraception;
- The patients who received ≥3 chemotherapies(Do not include endocrine therapy)after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
- The patients with a variety of factors that affect the oral administration and absorption of drugs;
- The patients with rapid progression of viscera invasion(liver lesion >1/2 viscera area or liver dysfunction);
- The patients have uncontrollable mental illness.
- The patients who had serious adverse effect to oral etoposide or were allergic to etoposide.
- The patients who have only bone metastasis without other measurable lesion;
- The patients experience severe cardiovascular diseases;
- The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.
- Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin <90g/L);
- Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value);
- Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);
- The patients have uncontrollable brain metastasis;
- The patients do not have good compliance to the therapy.
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:anlotinib
anlotinib 12mg qd p.o. d1-14/21day/cycle
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Anlotinib 12mg p.o. d1-14, 21days/cycle
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 |
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objective response rate(ORR)
時間枠:through study completion, an average of 1 year
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Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria.
CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
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through study completion, an average of 1 year
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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 |
---|---|---|
疾病制御率(DCR)
時間枠:学習完了まで、平均1年
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RESIST基準v1.1に従ってアンロイトニブによる治療を受け、疾患が安定している、または部分奏効または完全奏効を示した参加者の数。
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学習完了まで、平均1年
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無増悪生存期間 (PFS)
時間枠:登録日から最初に記録された進行の日まで、最長 24 か月まで評価
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カプランマイヤー法を使用して推定される無増悪生存期間は、インフォームドコンセントの日から死亡または病気の進行のいずれか早い方までの時間として定義されます。
病気の進行がなく生存している患者は、最後の病気の評価日に打ち切られます。
RECIST 1.1 に基づく進行性疾患 (PD) は、治療開始以降に記録された最小の合計 LD または 1 つ以上の新しい病変の出現を基準として、標的病変の最長直径 (LD) の合計が少なくとも 20% 増加していることを指します。
非標的病変のあいまいな進行も PD として認定されます。
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登録日から最初に記録された進行の日まで、最長 24 か月まで評価
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全生存期間(OS)
時間枠:登録日から死亡まで、最長 24 か月間評価されます
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OS。死因に関係なく、インフォームドコンセントの日から死亡日までの時間として定義されます。
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登録日から死亡まで、最長 24 か月間評価されます
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Safety and Tolerability
時間枠:through study completion, an average of 1 year
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All the treatment-related adverse events occurred as assessed by CTCAE v4.0
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through study completion, an average of 1 year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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circulating tumor DNA biomarker
時間枠:From date of enrollment until the date of first documented progression, assessed up to 24 months
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biomarkers measurement in dynamic circulating tumor DNA sequencing on the day of enrollment and at the end of every two cycle (28 days one cycle)
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From date of enrollment until the date of first documented progression, assessed up to 24 months
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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 (実際)
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 (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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乳房腫瘍の臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了