Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 533
- 试验地点
- 2
- 主要终点
- Disease-Free Survival
研究概览
简要总结
A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.
详细描述
[Background & Rationale for Study]
Optimization (rather than de-escalation) of surgery for breast cancer is essential for our patients, and thus it is an important topic discussed actively in all major conferences regarding breast cancer and oncology.
A previous study showed that lesion-to-background parenchymal signal enhancement ratio (L-to-B SER) ≤1.6 and/or size ≤ 0.2cm on breast MRI can distinguish pathological complete response (pCR) from minimal residual cancer following neoadjuvant systemic therapy (NST). In a separate prospective study, 40 patients with near pCR (either tumor size ≤ 0.5 cm or L-to-B SER ≤ 1.6 on MRI) were enrolled and evaluated for the accuracy of US-guided biopsy aided by MRI in predicting pCR in the breast after NST. US-guided multiple core needle biopsy (CNB) or VAB of the tumor bed, followed by standard surgical excision, was performed. Matched biopsy and surgical specimens were compared to assess pCR. In result, obtaining at least 5 biopsy cores based on tumor size ≤ 0.5 cm and an L-to-B SER of ≤ 1.6 on MRI resulted in 100% NPV and accuracy. No differences in accuracy were noted between CNB and VAB (90% vs. 90%). It was demonstrated that patients who meet these stringent criteria on MRI may forego surgery for breast cancer.
Also, a pooled analysis of data from The Royal Marsden, MD Anderson Cancer Center, and Seoul National University Hospital showed that a VAB obtaining at least 6 cores for a lesion ≤2cm on imaging after NST can accurately predict pCR at a FNR of 3.2%.
For patients who would not benefit from surgery, it is unnecessary in terms of both personal and national medical expenses. Therefore, in order to establish the rationale for whether surgery could be omitted for patients with predicted pCR, it is necessary to demonstrate that the survival rate of patients who skipped breast surgery after confirming no residual cancer on VAB is non-inferior than that of patients who underwent breast surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sex: female
- •Age: 20 years and older
- •Patients with no clinical/radiologic distant metastasis
- •Tumor type: Invasive ductal carcinoma
- •Tumor subtype: HER2 positive(including luminal B type, triple negative
- •Extent of disease: initial tumor size ≤ 5cm, cN0-2
- •Patients with measurable tumor size
- •Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6)
- •Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy
- •Patients with informed consent who are competent to make a voluntary decision
排除标准
- •Multifocal lesion (≥2)
- •Extent of residual microcalcification after neoadjuvant chemotherapy > 2cm
- •Bilateral breast cancer or inflammatory breast cancer
- •Contraindication to radiotherapy
- •History of previous contralateral breast cancer
- •Breast cancer patients with distant metastasis
- •Allergic history to MRI contrast
- •Male breast cancer
- •Patients incapable of giving informed consent owing to poor general conditions
- •Patients with BRCA mutation
- •Patients willing to receive breast surgery
- •Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)
研究组 & 干预措施
Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy
When there is no residual tumor cells on the vacuum-assisted biopsy specimen, breast surgery will be omitted. In the case of clinical N0 AND MRI size ≤ 0.5cm AND lesion-to-background signal enhancement ratio ≤1.6, sentinel lymph node biopsy will be omitted. Otherwise, sentinel lymph node biopsy will be performed. If necessary, axillary lymph node dissection will be performed.
干预措施: Breast surgery omission (Procedure)
结局指标
主要结局
Disease-Free Survival
时间窗: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.
次要结局
- Ipsilateral Breast Tumor Recurrence-Free Survival Ipsilateral Breast Tumor Recurrence-Free Survival(5 years after axillary surgery or VAB (in case of axillary surgery omission))
- QoL, symptoms, and medical cost(1 year after axillary surgery or VAB (in case of axillary surgery omission))
- Overall Survival(5 years after axillary surgery or VAB (in case of axillary surgery omission))
- Rate of residual axillary lymph node metastasis on axillary surgery(Upon axillary surgery)
- Invasive Disease-Free Survival Invasive Disease-Free Survival(5 years after axillary surgery or VAB (in case of axillary surgery omission))