A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Level of TGF-β1
研究概览
简要总结
The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Pathological confirmation of breast cancer
- •ER(+) and/or PR(+).
- •Post-menopausal woman
- •Age≤70 years old
- •Breast conservative surgery with axillary dissection or staging by either sentinel nodes biopsy or axillary sampling
- •Post-mastectomy patients with T1-T2 and N1-N3, or T3-T4 with any N Negative surgical margins
- •Karnofsky≥70
- •Laboratory criteria:
- •PLT≥100*109/L
- •WBC≥4000/mm3
- •HGB≥10g/dl
- •ALT and AST<2*ULN
- •No presence of metastatic disease
- •No other malignant tumour
排除标准
- •Presence of metastatic disease.
- •T1, T2, N0 with mastectomy
- •Non-infiltrative breast carcinoma underwent mastectomy
- •Other malignant tumor (concurrent or previous).
- •Positive surgical margins.
- •Patients with demonstrated hypersensitivity to Arimidex or any excipient.
- •Patients with severe renal impairment (creatinine clearance less than 20 ml/min).
- •Patients with moderate or severe hepatic disease.
- •Oestrogen-containing therapies should not be co-administered with Arimidex as they would negate its pharmacological action.
- •Not able or willing to sign informed consent
- •Autoimmune diseases including scleroderma, systemic lupus erythematosus and so on
研究组 & 干预措施
Control Arm
Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy
Interventions:
Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex
干预措施: Post radiotherapy commencement of Arimidex (Drug)
Study Arm
Investigational treatment: Arimidex commenced before and continued during radiotherapy.
Interventions:
Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy
干预措施: Pre-radiotherapy commencement of Arimidex (Drug)
Study Arm
Investigational treatment: Arimidex commenced before and continued during radiotherapy.
Interventions:
Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy
干预措施: Radiotherapy (Radiation)
Control Arm
Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy
Interventions:
Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Level of TGF-β1
时间窗: First analysis will occur 1 year after first subject enrolled
To compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
次要结局
- Acute skin reaction(First analysis will occur 1 year after first subject enrolled)
- Other serum inflammatory cytokine(First analysis will occur 1 year after first subject enrolled)
- Lung toxicity(First analysis will occur 1 year after first subject enrolled)
- Cosmetic outcomes(First analysis will occur 1 year after first subject enrolled)
- Local-regional recurrence(First analysis will occur 1 year after first subject enrolled)
- Correlation between TGF-β1 Change and Clinical Outcomes(First analysis will occur 1 year after first subject enrolled)
研究者
Jiayi Chen
Associate Professor, Vice Chairman of Department of Radiation Oncology
Fudan University