Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 41
- 主要终点
- Ipsilateral breast tumour recurrence (IBTR)
研究概览
简要总结
To de-escalate radiation therapy in women with breast cancer.
详细描述
The study is a prospective, multi-center, single arm cohort study of omission of adjuvant whole breast radiation therapy (WBRT) following breast conserving surgery (BCS) in patients with a pathological complete response (pCR) following neoadjuvant chemotherapy (NAC). Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. The first analysis is planned when follow-up is a median of 5 years. Study participants will not receive adjuvant WBRT, the current standard of care.
The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. In addition, any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The planned sample size is 352 study participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer (any tumour sub-type).
- •Negative lymph node involvement at initial presentation, documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy.
- •Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving targeted anti-Her2+ therapy.
- •Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified.
- •Treated by BCS with complete excision of the tumour bed and axillary staging surgery (either sentinel lymph node biopsy or axillary lymph node dissection).
- •Final pathology demonstrating a pCR [defined as absence of residual invasive and in-situ breast cancer within the breast or lymph nodes (ypT0N0)].
排除标准
- •Age less than 50 years.
- •Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4 disease).
- •Multicentric disease (i.e., breast cancer involving more than one quadrant in the same breast).
- •Prior history of ipsilateral or contralateral in-situ or invasive breast cancer. Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
- •Synchronous contralateral in-situ or invasive breast cancer.
- •BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation present associated with increased risk of breast cancer.
- •Other previous non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers or other cancers curatively treated with no evidence of disease for ≥ 5 years.
- •Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of treatment).
- •Patients with HR+ (hormone receptor) disease who are not planned to have endocrine therapy initiated.
- •Patients with Her2+ disease who have not received or are not planned to receive Her2 targeted therapy.
- •ECOG (Eastern Cooperative Oncology Group) performance status >
- •Inability to provide informed consent.
研究组 & 干预措施
Single Arm Cohort
The study population consists of women with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, that have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (defined as absence of residual invasive and in situ breast cancer within the breast or lymph nodes).
结局指标
主要结局
Ipsilateral breast tumour recurrence (IBTR)
时间窗: 5 years
defined as ipsilateral recurrence (invasive or insitu) in the ipsilateral breast or chest wall. Histological evidence of IBTR is required. All such events will be reviewed by a central adjudication committee.
次要结局
- Relapse free interval (RFI)(5 years)
- Mastectomy free interval(5 years)
- Overall survival (OS)(5 years)
- Disease free survival (DFS)(5 years)