NCT07245316尚未招募不适用
Avoiding Surgery in Estrogen Receptor Positive Atypical Ductal Hyperplasia and In-situ Carcinoma Treated With Endocrine Treatment Trial
Jeong Eon Lee1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2025年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- 5 year ipsilateral breast cancer incidence rate
研究概览
简要总结
This study aims to evaluate the 5-year invasive ipsilateral breast cancer incidence rate in patients with hormone-receptor positive, HER-2 negative atypical ductal hyperplasia or in-situ carcimona who omitted surgery and received endocrine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Inclusion criteria:
- •Female patients aged ≥35 years.
- •Diagnosed with atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) on core-needle biopsy, vacuum-assisted biopsy, or excisional biopsy.
- •Immunohistochemistry (IHC) performed on biopsy specimens confirming estrogen receptor (ER), progesterone receptor (PR), and HER2 status; eligible only if the ER Allred total score is ≥7 and HER2 status is negative.
- •All low- and intermediate-grade nuclear grades included; for high-grade lesions, only patients with a Ki-67 index ≤20% are eligible.
- •Lesion not definitely palpable on physical examination at diagnosis.
- •No prior breast surgery for ipsilateral or contralateral breast cancer, and no synchronous contralateral breast cancer.
- •Not diagnosed with pregnancy-associated breast cancer or breast cancer detected during lactation.
- •Negative serum or urine β-hCG prior to enrollment.
- •Provided written informed consent to participate in the study.
排除标准
- •Pregnant patients.
- •Patients with clinically significant psychiatric disorders (e.g., major depressive disorder) or those currently receiving psychiatric or antipsychotic medications.
- •Concomitant diagnosis of invasive breast cancer.
- •Evidence of axillary lymph node metastasis.
- •Carriers of BRCA1/2 mutations.
- •Male patients.
- •History of diagnosis or treatment for breast cancer.
- •Presence or history of other malignancies besides breast cancer.
- •Concomitant diagnosis of pleomorphic LCIS.
研究组 & 干预措施
Active monitoring arm
Experimental
Active monitoring with endocrine therapy in hormone-receptor positive, HER-2 negative DCIS, LCIS, ADH without surgery
干预措施: Avoiding surgery (Procedure)
结局指标
主要结局
5 year ipsilateral breast cancer incidence rate
时间窗: 5 years after the last patient enrollment
This study aims to evaluate the 5-year invasive ipsilateral breast cancer incidence rate in patients with hormone-receptor positive, HER-2 negative atypical ductal hyperplasia or in-situ carcimona who omitted surgery and received endocrine therapy.
次要结局
- Adjuvant chemotherapy rate(5 years after the last patient enrollment)
- invasive CBC rate(5 years after the last patient enrollment)
- OS(5 years after the last patient enrollment)
- BCSS(5 years after the last patient enrollment)
- Change in breast cancer-specific quality of life assessed by EORTC QLQ-BR23(At baseline, at 2 years, and at 5 years after the last patient enrollment)
- Change in health-related quality of life assessed by EORTC QLQ-C30(At baseline, at 2 years, and at 5 years after the last patient enrollment)
研究者
Jeong Eon Lee
Professor, Department of Surgery
Samsung Medical Center
研究点 (1)
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