12 週間のアジュバント ドセタキセルとトラスツズマブの併用による小さなリンパ節転移陰性、HER2 陽性の乳癌患者 (SOBER) (SOBER)
1cm以下の腫瘍、リンパ節陰性、HER2陽性乳がん（SOBER）の患者における12週間のアジュバントドセタキセルとトラスツズマB：単一群、非盲検、前向き、第2相試験
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
調査の概要
詳細な説明
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive 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
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200025
- Ruijin Hospital
-
-
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:
Women aged ≥18 years
Have finished radical operation
Pathologically confirmed dignosis of infiltrating primary breast cancer
According to AJCC ,pT≤1cm, pN0,no evidence for metastasis
Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ )
Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1,expected survival time > 12 months
Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function.
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
Written informed consent according to the local ethics committee requirements.
Exclusion Criteria:
pT>1cm or node positive
Metastatic breast cancer
Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
Has symptomatic peripheral neuropathy > grade 2 according to NCI
Known severe allergy to any drugs in this study
Has cadiac Dysfunction or lung dysfunction defined as follows:
- grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
- angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
- uncontrolled high-risk arryhthmia
- unconrolled hypertension
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
Patient is pregnant or breast feeding
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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 |
|---|---|
|
実験的：Experimental Arm
12 weeks adjuvant docetaxel plus trastuzumab |
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles. Docetaxel 100mg/m2，d1，iv，q3w*4 |
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 |
|---|---|---|
|
Disease-free Survival
時間枠：3-year estimates
|
Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up. |
3-year estimates
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Breast Cancer Specific Survival
時間枠：3-year estimates
|
Defined as the time from the date of surgery to death from breast cancer relapse; or censored at date last known alive. |
3-year estimates
|
|
Overall Survival
時間枠：3-year estimats
|
Defined as the time from the date of surgery to death from any cause; or censored at date last known alive. |
3-year estimats
|
|
Treatment-related adverse events
時間枠：up to 4 months
|
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0 |
up to 4 months
|
|
Change of LVEF after treatment
時間枠：up to 4 months
|
The change of LVEF after 12 weeks treatment compared to the baseline LVEF |
up to 4 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Li Zhu, doctor、Shanghai Jiao Tong University School of Medicine
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RJBC1712
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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