NCT07483307招募中2 期
Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by participant or legally authorized representative
- •Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.
- •Tumors of the ER+/HER2- subtype, defined as:
- •ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.
- •HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.
排除标准
- •Patients with prior ipsilateral breast cancer.
- •Patients with advanced regional disease (cN2/cN3) or stage 4 disease.
- •Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.
- •Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).
- •Patients with gadolinium allergy, precluding the use of breast MRI.
研究者
研究点 (7)
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