The Surgical Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size in Patients Had a Favourable Response to Neoadjuvant Chemotherapy
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:
-
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.
-
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
-
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
- 是
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
samir hosny mahmoud
breast surgeon
Assiut University
