RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 801
- 试验地点
- 19
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.
详细描述
Study Rationale:
There is some evidence that identifying non-responders early in neoadjuvant treatment and offering alternative agents (response-guided therapy) increased pathological complete response (pCR) rates and/or survival resulting in improved care and incremental cost effectiveness.
Differentiating non-responders to chemotherapy from responders with reliable guidance tools early during therapy is crucial to the success of response-guided therapy.
The current study aims to provide validation results of RDA as a tumor response assessment tool that uses tumor core biopsies starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.
Study Objectives and Endpoints:
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
盲法说明
This is a diagnostic study. The RDI operator that assesses patient response to therapy using the RDA test is blinded to patient outcome. The clinicians and patients will not receive the RDI score in order to not act on the RDA test result (because this is an investigational study).
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
- •Women aged at least 18 years;
- •Patients must be able to provide informed consent and sign the informed consent form to participate in the RDA study before any study procedures starts;
- •Newly diagnosed clinical stage I, II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal;
- •Tumour size at least 1 cm in one dimension by clinical or radiographic exam (WHO criteria);
- •Must have histological confirmation of invasive breast cancer of any subtype or grade;
- •Patient is scheduled for neoadjuvant chemotherapy +/- antibodies and +/- other drugs according to Standard of Care;
- •Patient willing to have 2 research core needle biopsies (for RDA) taken at 2 collection timepoints during neoadjuvant chemotherapy treatment.
排除标准
- •Patient who has had prior local (i.e. surgery or radiotherapy) or systemic (i.e. endocrine or cytotoxic) therapy for the current breast cancer;
- •Participation in another interventional clinical trial with concurrent treatment with experimental drugs to treat the current breast cancer during the period of neoadjuvant therapy (from diagnosis until surgery);
- •Stage IV breast cancer;
- •Bilateral or multicentric breast tumour;
- •Prior malignant disease except curatively treated in-situ maligancies;
- •Concurrent pregnancy;
- •Breast feeding woman;
- •Concurrent medical, psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial;
- •Reasons indicating risk of poor compliance with study procedures;
- •Patient not able to consent;
研究组 & 干预措施
Single Interventional Study Arm
There will be 2 biopsy collection time points with 2 core needle biopsy specimens taken at each biopsy collection time point for RDA analysis during neoadjuvant chemotherapy.
干预措施: Core needle biopsy (Procedure)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: At surgery after completion of neoadjuvant therapy
(ypT0,ypN0) / (ypTis,ypN0)
次要结局
- Residual Cancer Burden(At surgery)
- Disease-free survival(5 years of survival follow-up)