KCT0009061招募中Unknown
Prospective phase II study of tailored RadioTherapy according to the response after NeoAdjuvant Chemotherapy followed by surgery in patients with lymph node metastasis in axillary level II-III and/or internal mammary and/or supraclavicular lymph node at diagnosis.
ational Cancer Center0 个研究点目标入组 424 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- Female
入选标准
- •1. Women aged 20-70
- •2. Patient must have pathologically diagnosed as invasive breast cancer
- •3. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4. Patient must have clinically T1-4 breast cancer (before standard neoadjuvant chemotherapy±targeted therapy)
- •5. Patient must have lymph node metastasis in axillary level II-III and/or internal mammary and/or supraclavicular lymph node confirmed by fine needle aspirate(FNA) or imaging study (before standard neoadjuvant chemotherapy±targeted therapy)
- •6. Patient who have undergone breast conserving surgery or total mastectomy
- •7. Patient who have undergone sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection
- •8. Patients with hormone receptors, HER-2, Ki-67 index test results (HER-2 2+ cases require FISH or SISH)
排除标准
- •1. In the case of distant metastasis (before standard neoadjuvant chemotherapy±targeted therapy)
- •2. Bilateral breast cancer patients
- •3. Male breast cancer patients
- •4. Patient with a history of radiation therapy to the ipsilateral breast or supraclavicular area in the past
- •5. Patient diagnosed with another cancer within 5years from the start date of radiation therapy(except for thyroid cancer, in situ cervical cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin)
- •6. If pregnant or breastfeeding
- •7. If standard neoadjuvant chemotherapy±targeted therapy has not been completed as planned
- •8. If there is no level II-III axillary lymph node involvement or supraclavicular lymph node metastasis, and only internal mammary lymph node metastasis is present at the time of diagnosis
研究者
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