ISRCTN54765244进行中（未招募）3 期
POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomized controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes
niversity Hospitals of Derby and Burton NHS Foundation Trust0 个研究点目标入组 1,900 人开始时间: 2014年2月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,900
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34857578/ (added 06/12/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 14/06/2019:
- •Women will be eligible for inclusion only if ALL of the following criteria apply:
- •1. 18 years or older
- •2. Unifocal or multi-focal invasive tumour with lesion =5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
- •3. At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
- •4. Fit for axillary treatment and adjuvant therapy
- •5. Have given written informed consent
- •Previous inclusion criteria:
- •Women will be eligible for inclusion only if ALL of the following criteria apply:
- •1. 18 years or older
- •2. Unifocal or multifocal invasive tumour with lesion =5 cm in its largest dimension, measured pathologically or for women who are randomised intraoperatively
- •largest tumour diameter on mammogram or ultrasound.
- •3. No axillary nodal metastasis on clinical and ultrasound examination.
- •4. At sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
- •5. Fit for axillary treatment and adjuvant therapy
- •6. Have given written informed consent
排除标准
- •Current exclusion criteria as of 14/06/2019:
- •Women will be excluded if they have:
- •1. Bilateral invasive breast cancer
- •2. More than 2 nodes with macrometastases
- •3. Neoadjuvant therapy for breast cancer except:
- •3.1. If sentinel node biopsy performed prior to neoadjuvant therapy in women with early breast cancer
- •3.2. Short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months)
- •4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy
- •5. Not receiving adjuvant systemic therapy
- •6. Previous cancer less than 5 years previously or concomitant malignancy except:
- •6.1. Basal or squamous cell carcinoma of the skin or
- •6.2. In situ carcinoma of the cervix or
- •6.3. In situ melanoma
- •6.4. Contra- or ipsilateral in situ breast cancer
- •Previous exclusion criteria:
- •Women will be excluded if they have:
- •1. Bilateral breast cancer
- •2. More than 2 sentinel node macrometastases or extranodal invasion
- •3. Neoadjuvant therapy for breast cancer
- •4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy
- •5. Not fit or eligible to receive adjuvant systemic therapy
- •6. Previous or concomitant malignancy except:
- •6.1. Adequately treated basal or squamous cell carcinoma of the skin or
- •6.2. Adequately treated in situ carcinoma of the cervix or
- •6.3. Adequately treated in situ melanoma
- •6.4. Contra- or ipsilateral in situ breast cancer
研究者
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