ACTRN12606000305527进行中（未招募）2 期
A phase II clinical trial assessing clinical and pathological response rates after the administration of neoadjuvant doxorubicin & docetaxel to women with locally advanced breast cancer (UICC staging T3 or T4, N1 or N2, M0)
The Cancer Council Victoria0 个研究点目标入组 40 人开始时间: 2000年11月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- ot stated 至 70 Years（—）
- 性别
- Female
入选标准
- •1. Pre and post menopausal women with histologically proven locally advanced breast cancer as assessed by at least two clinicians ie surgeon &/or medical oncologist &/or radiation oncologist (UICC guidelines disease ranging between T3 and N2 to T4c and N1)2. Diagnosis of invasive adenocarcinoma is confirmed by core biopsy. A fine needle aspirate is acceptable but not encouraged3. Axillary lymph nodes clinically examined and may contain invasive tumour; may be fixed to one another or other structures4. The determination of oestrogen (ER) and progresterone (PgR) receptors is mandatory and results must be known by the end of chemotherapy to determine if hormonal therapy is indicated. ER and/or PgR are considered positive if > or = 1% of cells stain positively regardless of staining intensity, using immunohistochemistry5. All subjects should be evaluated at baseline and negative for distal and regional metastatic disease6. All subjects must be fit for and agree in principle to mastectomy and axillary dissection prior to study entry7. Subjects must be < or = 70 yrs of age8. Adequate renal and liver function and blood counts9.Left ventricular efection fraction (LVEF) must be normal (>50%) and electrocardiography (ECG) must not preclude anthracycline use.10.The subject must be able to give written informed consent according to the rules at each institution. The human rights Declaration of Helsinki must be the basis for the inclusion of patients.
排除标准
- 未提供
研究者
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