12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Tumors ≤1cm, Node-negative, HER2-positive Breast cancER (SOBER):a Single-grouparm, Open-label, Prospective, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Disease-free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Experimental Arm
12 weeks adjuvant docetaxel plus trastuzumab
干预措施: Docetaxel (Drug)
Experimental Arm
12 weeks adjuvant docetaxel plus trastuzumab
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: 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.
次要结局
- Change of LVEF after treatment(up to 4 months)
- Breast Cancer Specific Survival(3-year estimates)
- Overall Survival(3-year estimats)
- Treatment-related adverse events(up to 4 months)