Prospective Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-sensitive Breast Cancer Who Remain Premenopausal or Resume Menstruation After Chemotherapy: ASTRRA- IV Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,483
- 试验地点
- 1
- 主要终点
- Long-term Disease-Free Survival Analysis of the ASTRRA Trial
研究概览
简要总结
This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy. The study will assess recurrence, breast cancer-specific survival, and overall survival beyond 10 years to determine the long-term benefits of OFS treatment.
详细描述
To evaluate the long-term outcomes beyond 10 years of the Korean Breast Cancer Society-sponsored multicenter prospective ASTRRA trial, we aim to compare the effects of adding 2 years of ovarian function suppression (OFS) therapy to standard tamoxifen treatment in premenopausal young women with hormone receptor-positive breast cancer who preserved or recovered ovarian function after chemotherapy. Given the characteristic pattern of delayed recurrence in hormone receptor-positive breast cancer compared with other molecular subtypes, this long-term follow-up study will assess the durability and safety of the treatment strategy by evaluating disease-free survival (DFS) beyond 10 years, breast cancer-specific survival, and overall survival. In addition, through analyses of recurrence patterns according to treatment groups, we aim to determine the long-term impact of additional OFS therapy on reducing different types of recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women with hormone receptor-positive breast cancer enrolled in the ASTRRA trial (NCT00912548).
- •Patients enrolled and randomized in the ASTRRA study between March 1, 2009, and July 17, 2018 (excluding screening failures).
- •Patients with available long-term follow-up information.
排除标准
- •Patients with primary breast cancer meeting any of the following criteria:
- •Hormone receptor-negative breast cancer Unknown hormone receptor status
- •Patients with a history of hysterectomy or bilateral oophorectomy
- •Patients with breast sarcoma or squamous cell carcinoma of the breast
- •Patients with a history of malignancy other than breast cancer within 5 years prior to enrollment
- •Patients with thrombocytopenia
- •Patients who had previously received CMF chemotherapy (cyclophosphamide, methotrexate, and fluorouracil)
结局指标
主要结局
Long-term Disease-Free Survival Analysis of the ASTRRA Trial
时间窗: 25-year follow-up
Long-term Survival Analysis of Premenopausal Young Breast Cancer Patients with Preserved or Recovered Ovarian Function after Chemotherapy Receiving Ovarian Function Suppression Plus Tamoxifen
次要结局
未报告次要终点