KCT0006371招募中未知
Selective Omission of Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy In HER-2 positive/Triple Negative Breast Cancer Patients with Excellent Radiologic Response to the Breast and Axilla, prospective, multi-center, single-arm study
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 178
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 69?(Year)（—）
- 性别
- Female
入选标准
- •1) undergone neoadjuvant chemotherapy
- •2) HER-2 or triple negative breast cancer
- •3) clinical stage T1-3, N0-1, M0 (AJCC 8th)
- •4) not Inflammatory breast cancer
- •5) neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed)
- •- least four times anthacycline or taxane-based regimens
- •- no axilla lesion progression during chemotherapy
- •- no period of adverse response during chemotherapy
- •6) undergone anti HER-2 therapy in HER-2 positive patient
- •7) no preoperative anti hormonal therapy
- •8) no preoperative radiation therapy?
- •9) did not axillary lymph node biopsy before neoadjuvant chemotherapy
- •10) physical examination expected complete remission. And radiological expected Tumor size = 2cm or non-mass enhancement = 4cm
- •11) no previous axilla surgery
- •12) no previous ipsilateral breast surgery for invasive cancer
- •13) no Pregnancy-associated breast cancer
- •14) ECOG performance status 0-1
- •15) Serum or urine b-HCG negative
- •16) agree to the consent form
- •17) 20=Age<70
排除标准
- •1) During pregnancy
- •2) major depression or taking psychiatric medication
- •3) significant psychiatric disorder or history of taking antipsychotic drugs
- •4) any other lymph node metastasis than axillary lesion
- •5) undergoing total mastectomy
- •6) do not agree to the consent form
研究者
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