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临床试验/NCT05115279
NCT05115279招募中不适用

The Surgical Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size in Patients Had a Favourable Response to Neoadjuvant Chemotherapy

Assiut University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1
试验地点
1
主要终点
breast conservative surgery after neoadjuvant chemotherapy

研究概览

简要总结

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 (1). The incidence of breast cancer increases with age (2, 3). 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(4) Neoadjuvant chemotherapy (NACT) is considered the standard of care for the management 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. (5). Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors(6) . 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 [7]. Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided (8).

Complete pathological response after neoadjuvant systemic treatment is high, while complete clinical response rates are even higher. Because it is difficult to localize the original tumor bed after a complete clinical and radiological response, marking the tumor before the start of neoadjuvant systemic treatment is required to enable breast-conserving surgery afterward. Achieving adequate margins of excision is an important component of breast surgery. Local recurrence rates are significantly higher for patients who have positive margins of excision (9) some prospective and retrospective data suggested that patients with BCT after neoadjuvant therapy may have an increased risk for the development of a local recurrence .

If this were true, there would be no further advantage of neoadjuvant therapy and this treatment option could be questioned altogether.

A common question raised with respect to performing breast-conserving therapy after neoadjuvant chemotherapy is the volume of breast tissue that should be resected

详细描述

Study subjects:

  1. Inclusion criteria:

  2. Female patients with operable breast cancer

  3. Female Patient aged from 20 to 60 years old

  4. Patients who are fit for general anesthesia.

  5. Patients who provide a written informed consent.

  6. Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.

  7. Exclusion criteria:

  8. Female patients less than 20 years old

  9. Stage 4 breast cancer

  10. Patient has no pathological or clinical response to NACT

  11. Patients who are contraindicated for radiotherapy

  12. Pregnant patients in first trimester

  13. Patient with inflammatory carcinoma

  14. Sample Size Calculation:

Prospective trial study include 50 patient whom fulfilled the inclusion criteria 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): This prospective study is including patients will be diagnosed breast cancer and will receive neoadjuvant chemotherapy .

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

入选标准

  • a. Inclusion criteria:
  • Female patients with operable breast cancer
  • Female Patient aged from 20 to 60 years old
  • Patients who are fit for general anesthesia.
  • Patients who provide a written informed consent.
  • Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.

排除标准

  • Exclusion criteria:
  • Female patients less than 20 years old
  • Stage 4 breast cancer
  • Patient has no pathological or 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

breast conservative surgery after neoadjuvant chemotherapy

时间窗: 4 years

negative inked margin by intraoperative frozen section annual free PET CT scan from recurrence anf metastasis

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

samir hosny mahmoud

breast surgeon

Assiut University

研究点 (1)

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