Real-world Integration of De-Escalation in Axillary Surgery for Postmenopausal, Early Stage HR+HER2- Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 620
- 试验地点
- 2
- 主要终点
- Isolated regional recurrence free survival
研究概览
简要总结
The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka).
Targeted group are postmenopausal patients, older than 55 years, diagnosed with hormone-receptor-positive breast cancer, with primary tumour less than 3 cm and unaffected axilla on clinical exam and axillary ultrasound.
The main questions we aim to answer are:
- if this treatment de-escalation affects patient oncological outcomes (cancer recurrence)?
- if this treatment de-escalation affects patient clinical outcomes (early and late complications related to axillary surgery)?
- if this omission of pathological examination of sentinel lymph node affects recommendations on postoperative treatments (irradiation and systemic therapy)? Researchers will compare outcomes between participants submitted to sentinel lymph node biopsy and participants in whom the procedure is omitted to answer those questions.
Participants will be asked to:
- decide in which group they wish to participate
- visit the clinic for checkups and tests once every 6 months in first two years and yearly thereafter up to 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed hormone receptor positive, HER2 negative invasive breast cancer or DCIS with microinvasion, histologically confirmed, in postmenopausal patients older than 55 years, with primary tumour up to 3 cm and uninvolved axillary lymph nodes on clinical examination and on axillary ultrasound performed in Clinical Hospital Centre Rijeka. Patients should be eligible for breast conserving surgery and adjuvant whole breast irradiation.
排除标准
- •Patients younger than 55 years of age and/or premenopausal, with cN1-3 status (confirmed cytologically or histologically), or with multiple suspicious lymph nodes on axillary ultrasound, regardless of cytological/histological confirmation.
- •Patients diagnosed with pure breast carcinoma in situ (DCIS) without focal invasion
- •Patients with tumour larger than 3 cm or with cT4 status, with de novo metastatic disease
- •Patients with a breast cancer of HER2+ or triple-negative immunophenotype
- •Patients who have received any type of neoadjuvant systemic therapy before surgery and those who have a previous personal history of invasive breast cancer
- •Patients with extensive multifocal or multicentric breast cancer, patients scheduled for mastectomy, partial breast irradiation or who refuse recommended adjuvant systemic oncological treatment
- •Patients who do not wish to participate in a clinical trial
研究组 & 干预措施
Experimental arm (NO-SLNB)
Sentinel lymph node biopsy will be omitted for all participants
干预措施: omission of sentinel lymph node biopsy (Procedure)
Standard of care (SLNB)
Standard of care treatment (SLNB) will be performed in all participants
干预措施: sentinel lymph node biopsy (Procedure)
结局指标
主要结局
Isolated regional recurrence free survival
时间窗: 5 years
Isolated axillary lymph node recurrence free interval (time from surgery until axillary lymph node recurrence, provided that axillary recurrence is the first and only recurrence)
Disease free survival
时间窗: 5 years
Cancer recurrence-free interval (time from surgery until any recurrence)
Isolated regional recurrence free survival
时间窗: 5 years
Isolated axillary lymph node recurrence free interval (time from surgery until axillary lymph node recurrence, provided that axillary recurrence is the first and only recurrence)
Disease free survival
时间窗: 5 years
Cancer recurrence-free interval (time from surgery until any recurrence)
次要结局
- Isolated regional recurrence rate(5 years)
- Rate of adjuvant chemotherapy recommendation in standard and experimental arm(5 years)
- Isolated regional recurrence rate(5 years)
- Any invasive recurrence rate(5 years)
- Rate of adjuvant chemotherapy recommendation in standard and experimental arm(5 years)
- Rate of adjuvant regional nodal irradiation in standard and experimental arm(4 years)
- Rate of early postoperative complications in axilla in standard arm(3 years (accrual period))
- Rate of late complications of axillary surgery in standard arm(5 years)
- Any invasive recurrence rate(5 years)
- Rate of adjuvant regional nodal irradiation in standard and experimental arm(4 years)
- Rate of early postoperative complications in axilla in standard arm(3 years (accrual period))
- Rate of late complications of axillary surgery in standard arm(5 years)
研究者
Ana Car Peterko
General Surgeon and surgical oncologist, FEBS (breast surgery), CEBS
Clinical Hospital Center Rijeka