A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Decrease in tumor cell proliferation and induced apoptosis.
研究概览
简要总结
To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.
详细描述
We will perform a randomized, open-label, single-institution study. It will compare the efficacy of three different endocrine treatment regimens (Anastrozole +/- Fulvestrant or Tamoxifen) in changing proliferation-index and inducing apoptosis during a 2-6 week pre-operative treatment period in breast cancer patients. These results will be correlated to gene expression profiles, phosphorylation status of the ER, SNPs in CYP450 sequences, tamoxifen metabolite concentrations, changes in estrogen serum levels and protein expression patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proven invasive adenocarcinoma of the breast
- •Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer)
- •WHO-performance score 0 or 1
- •Written informed consent
排除标准
- •Clues of metastatic disease by clinical examination according to most recent NABON guidelines
- •Multicentric breast cancer
- •Inflammatory breast cancer
- •Hormone replacement during the last 12 months
- •Other systemic treatment during the waiting time till surgery
- •Already planned date for surgery within the next 2 weeks
- •Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
- •Patient's refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment
- •NB: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS within the last 15 years is not an exclusion criterium.
- •NB: Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during the study.
研究组 & 干预措施
3
Tamoxifen
干预措施: Tamoxifen (Drug)
2
Anastrozole + Fulvestrant
干预措施: Anastrozole+Fulvestrant (Drug)
1
Anastrozole
干预措施: Anastrozole (Drug)
4
Tamoxifen (pre-menopausal and male patients)
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Decrease in tumor cell proliferation and induced apoptosis.
时间窗: At baseline and after 2-6 weeks of endocrine treatment
次要结局
- Comparison of changes in gene expression after different endocrine treatment exposures(At baseline and after endocrine treatment)