CTRI/2015/05/005789已完成4 期
AN INDIAN MULTICENTRIC OPEN LABEL PROSPECTIVE PHASE IV STUDY TO EVALUATE SAFETY AND EFFICACY OF TRASTUZUMAB IN HER2 POSITIVE, NODE POSITIVE OR HIGH RISK NODE NEGATIVE BREAST CANCER AS PART OF A TREATMENT REGIMEN CONSISTING OF DOXORUBICIN, CYCLOPHOSPHAMIDE, WITH EITHER DOCETAXEL OR PACLITAXEL(AC→TH) OR DOCETAXEL AND CARBOPLATIN (TCH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 6
- 主要终点
- To evaluate the safety of Trastuzumab for the treatment of HER2-positive node positive or high risk node negative breast cancer patients with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel (AC→TH) or a regimen consisting of docetaxel and carboplatin (TCH) in Indian population.
研究概览
简要总结
India would recruit 109 patients in the study. India will have the first patient enrolled in 20-May-2015.This Open label study is being conducted to evaluate the safety and efficacy of trastuzumab in Her2 positive, node positive or high risk node negative breast cancer as part of a treatment regimen consisting of Doxorubicin, Cyclophosphamide, with either Docetaxel or Paclitaxel(ac->th) or Docetaxel and Carboplatin (TCH).The anticipated time on study treatment is until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients must meet the following criteria for study entry: •Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •â€¢Adult female patients, ≥18 years of age •Histologically confirmed early invasive HER2 positive, node positive or high risk node negative breast cancer with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I to IIIA that is eligible for adjuvant treatment with Trastuzumab •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 •HER2 over-expression/amplification defined as either IHC3+, or IHC2+ and FISH-positive as determined in a central laboratory •At time of starting Trastuzumab therapy, Left ventricular ejection fraction (LVEF) measured by echocardiography •Screening left ventricular ejection fraction (LVEF) ≥ 55% •Adequate bone marrow, renal, and hepatic function •Agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry: •Any contraindication to Trastuzumab •Previous adjuvant breast cancer treatment with an approved or investigational anti HER2 agent •History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies who have been disease-free for at least 5 years •Past history of ductal carcinoma in situ and/or lobular carcinoma that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops •Locally advanced (stage IIIB and IIIC) and Metastatic disease (stage IV) •Clinically relevant cardiovascular disorder or disease •Uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy •History of severe allergic or immunological reactions, e.g. difficult to control asthma •Pregnant or lactating women.
结局指标
主要结局
To evaluate the safety of Trastuzumab for the treatment of HER2-positive node positive or high risk node negative breast cancer patients with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel (AC→TH) or a regimen consisting of docetaxel and carboplatin (TCH) in Indian population.
时间窗: Assessed every 3 months (after every 4th cycle) until disease progression
次要结局
- To determine the disease free survival (DFS); To determine the overall survival (OS).
研究者
研究点 (6)
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