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临床试验/NCT06130241
NCT06130241尚未招募不适用

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?

Assiut University0 个研究点目标入组 30 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection?

研究概览

简要总结

The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.

详细描述

Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers . The incidence of breast cancer increases with age.

Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage

Neoadjuvant chemotherapy (NACT) is considered the standard of care for the anagement of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease.

. Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors.

Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates .

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
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients with operable breast cancer who had node-positive disease at presentation and pathological confirmation with either FNA or core biopsy
  • Female Patient aged from 18 to 60 years old
  • Patients who are fit for general anesthesia.
  • Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.

排除标准

  • Stage 4 breast cancer
  • Patient has no clinical response to NACT
  • Patients who are contraindicated for radiotherapy
  • Pregnant patients in first trimester
  • Patient with inflammatory carcinoma

结局指标

主要结局

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection?

时间窗: Two year

To evaluate the accuracy and safety of SLNB after neoadjuvant chemotherapy by 2 years follow up patients for recurrence clinically and radiologically by ultrasonography on axilla after one and two years .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hosny Mahmoud

Resident doctor at general surgery department in Assuit university hospital

Assiut University

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