Tracking Triple-negative Breast Cancer Evolution Through Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 149
- 试验地点
- 10
- 主要终点
- Rate of pathological complete response (pCR)
研究概览
简要总结
A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-years or older
- •Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator
- •Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry
- •Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines
- •T1c-4 tumours (including inflammatory cancers), with any nodal status non candidate for conservative surgery upfront. Bilateral or multifocal cancer is permitted provided that all sites are HER2-negative and at least one site is ER- and PR-negative.
- •Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- •Patient with social insurance coverage
排除标准
- •Confirmed metastatic disease at initial presentation
- •Any contraindication to the biopsy procedure
- •Previous or current malignancies of other origin within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin
- •Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
- •Individuals deprived of liberty or placed under the authority of a tutor
研究组 & 干预措施
All included patients
Patients will undergo a biopsy and provide a blood sample prior to initiating standard neoadjuvant chemotherapy. Additional tissue samples will be collected at the following time points:
- (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy
- At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements).
- Biopsy of a metastatic site in the event of disease recurrence.
Blood samples will be obtained during neoadjuvant chemotherapy, prior to surgery and at 6-month intervals for up to 5 years post-surgery. In the event of recurrent disease, blood samples will be collected i) at the time of recurrence, ii) at the first CT scan on treatment and iii) at each subsequent relapse for up to 5 years post-surgery.
干预措施: Biopsy (Procedure)
All included patients
Patients will undergo a biopsy and provide a blood sample prior to initiating standard neoadjuvant chemotherapy. Additional tissue samples will be collected at the following time points:
- (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy
- At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements).
- Biopsy of a metastatic site in the event of disease recurrence.
Blood samples will be obtained during neoadjuvant chemotherapy, prior to surgery and at 6-month intervals for up to 5 years post-surgery. In the event of recurrent disease, blood samples will be collected i) at the time of recurrence, ii) at the first CT scan on treatment and iii) at each subsequent relapse for up to 5 years post-surgery.
干预措施: Biopsy (optional) (Procedure)
All included patients
Patients will undergo a biopsy and provide a blood sample prior to initiating standard neoadjuvant chemotherapy. Additional tissue samples will be collected at the following time points:
- (optional) biopsy of primary tumour after 4 cycles of neoadjuvant chemotherapy
- At the time of surgery (samples of the primary tumour and lymph nodes which are surplus to diagnostic requirements).
- Biopsy of a metastatic site in the event of disease recurrence.
Blood samples will be obtained during neoadjuvant chemotherapy, prior to surgery and at 6-month intervals for up to 5 years post-surgery. In the event of recurrent disease, blood samples will be collected i) at the time of recurrence, ii) at the first CT scan on treatment and iii) at each subsequent relapse for up to 5 years post-surgery.
干预措施: Biopsy (metastatic) (Procedure)
结局指标
主要结局
Rate of pathological complete response (pCR)
时间窗: pCR will be defined at the time of surgery on the tumor specimen
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system)
次要结局
- Invasive disease-free survival(from surgery until 5 years post-surgery)
- Overall survival(from surgery until 5 years post-surgery)