POSNOC - POsitive Sentinel NOde: Adjuvant Therapy Alone Versus Adjuvant Therapy Plus Clearance or Axillary Radiotherapy. A Randomised Controlled Trial of Axillary Treatment in Women With Early Stage Breast Cancer Who Have Metastases in One or Two Sentinel Nodes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,900
- 试验地点
- 50
- 主要终点
- Axillary recurrence
研究概览
简要总结
POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.
Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years.
Stratification: Institution, Age (<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no).
Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).
Sample Size: 1900 participants
Follow-up: Participants will be followed up for 5 years.
Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •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)
- •Fit for axillary treatment and adjuvant therapy
- •Have given written informed consent
排除标准
- •bilateral invasive breast cancer
- •more than 2 nodes with macrometastases
- •neoadjuvant therapy for breast cancer except:
- •if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer
- •short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months)
- •previous axillary surgery on the same body side as the scheduled sentinel node biopsy
- •not receiving adjuvant systemic therapy
- •previous cancer less than 5 years previously or concomitant malignancy except:
- •basal or squamous cell carcinoma of the skin
- •in situ carcinoma of the cervix
- •in situ melanoma
- •contra- or ipsilateral in situ breast cancer
研究组 & 干预措施
Adjuvant therapy alone
Women in this arm will have adjuvant therapy but no treatment to their armpit after surgery. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to this arm.
干预措施: Adjuvant therapy (Other)
Adjuvant therapy plus axillary treatment
Women in this arm will have adjuvant therapy plus treatment to their armpit after surgery. Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
干预措施: Adjuvant therapy (Other)
Adjuvant therapy plus axillary treatment
Women in this arm will have adjuvant therapy plus treatment to their armpit after surgery. Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
干预措施: Axillary treatment (Procedure)
结局指标
主要结局
Axillary recurrence
时间窗: 5 years
Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
次要结局
- Anxiety (Spielberger State/Trait Anxiety Inventory)(3 years)
- Economic evaluation (EQ-5D-5L (EuroQoL)(3 years)
- Distant metastasis(5 years)
- Disease free survival(5 years)
- Overall survival(5 years)
- Arm morbidity(3 years)
- Local (breast or chest wall) recurrence(5 years)
- Regional (nodal) recurrence(5 years)
- Axillary recurrence free survival(5 years)
- Contralateral breast cancer(5 years)
- Non-breast malignancy(5 years)
- Quality of life(3 years)
- Time to axillary recurrence(5 years)
研究者
Dr Amit Goyal
Consultant Oncoplastic Breast Surgeon & Associate Professor
University Hospitals of Derby and Burton NHS Foundation Trust