2023-506135-14-00招募中4 期
Optimizing extended adjuvant endocrine therapy in patients with breast cancer: a registry-based randomized clinical trial
Region Oerebro Laen15 个研究点 分布在 1 个国家目标入组 3,832 人开始时间: 2023年10月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,832
- 试验地点
- 15
- 主要终点
- Overall survival
研究概览
简要总结
- In women with high-risk luminal breast cancer who converted from premenopausal to postmenopausal after an initial adjuvant endocrine therapy of 5 years tamoxifen, to investigate if extended therapy using a switching strategy with 5-years of aromatase inhibitors (AI) is more effective than continued tamoxifen therapy for 5 years.
- In postmenopausal women with high-risk luminal breast cancer after an initial adjuvant endocrine therapy of 5-year AI, to investigate whether an extended adjuvant therapy using a switching strategy of 5-year tamoxifen is more effective than 2-year of AI.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for Cohort 1 (premenopausal women at diagnosis converted to postmenopausal): Women who were pre- or perimenopausal at diagnosis; luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease); treated with tamoxifen for at least 80% of a 5-year period (+/- 6 months from treatment completion); no clinical signs of metastasis after 5 years tamoxifen treatment; cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy; postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines; inclusion criteria for cohort 2: (postmenopausal women at diagnosis): Women who were postmenopausal at diagnosis; luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease); treated with AI for at least 80% of a 5-year period (+/- 6 months from treatment completion); no clinical signs of metastasis after 5 years AI treatment; cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.
排除标准
- •Exclusion criteria for Cohort 1: Prior invasive breast cancer diagnosis; other invasive malignancy within 5 years before or after breast cancer diagnosis; non-luminal breast cancer (defined as estrogen-receptor < 10%); patients who were unable to complete at least 80% of 5-year initial treatment with tamoxifen; uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions); recurrent or metastatic breast cancer within or after 5-year initial treatment with tamoxifen. DCIS-only is allowed at any time before or after breast cancer diagnosis. Exclusion criteria for cohort 2: Exclusion criteria for Cohort B: Prior invasive breast cancer diagnosis; other invasive malignancy within 5 years before or after breast cancer diagnosis; non-Luminal breast cancer (defined as estrogen-receptor < 10%); patients who were unable to complete at least 80% of 5-year initial treatment with AI; recurrent or metastatic breast cancer within or after 5-year initial treatment with AI. DCIS-only is allowed at any time before or after breast cancer diagnosis; no contraindication for tamoxifen therapy.
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Invasive disease-free survival; distant disease-free survival; breast cancer-specific survival; toxicity (grade 3 or 4); quality of Life; adherence; healthcare resource utilization; sick leave and early retirement
研究者
Antonis Valachis
Scientific
Region Oerebro Laen
研究点 (15)
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