Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Agendia
- 入组人数
- 1,142
- 试验地点
- 75
- 主要终点
- Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1)
研究概览
简要总结
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.
详细描述
This will be a prospective observational, case-only study linking MammaPrint, BluePrint, TargetPrint, TheraPrint and possible additional profiles of interest to treatment response and Distant Metastases Free Survival (DMFS) and Relapse Free Survival (RFS). Only patients who receive neo-adjuvant therapy can participate.
For this project, approximately 50-70 institutions in the US will be invited to contribute clinical patient data from enrolled patients after a MammaPrint, TargetPrint, BluePrint and TheraPrint test has been successfully performed and the patient has started neo-adjuvant therapy.
Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a recognized alternative.
The clinical data is to be entered online at 4 time points; amounting to four Case Report Forms (CRFs). Data will be collected on an ongoing basis, the first CRF must be completed within 6 weeks after the MammaPrint, BluePrint, TargetPrint, and TheraPrint result was provided. The second CRF should be completed 4 weeks after definitive surgery. CRF 3 and CRF4 will be completed 2-3 and 5 years after surgery.
It is expected that we will enroll around 1000 patients in 4 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after successful MammaPrint assay
- •Age 18-90
- •Written informed consent
排除标准
- •Patients who have had excisional biopsy or axillary dissection Patients with confirmed distant metastatic disease
- •Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- •Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer
- •Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
结局指标
主要结局
Endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1)
时间窗: Up to 6 months
The primary endpoint for patients with neo-adjuvant hormonal therapy is partial response which is defined as decrease in longest tumor diameter. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
Chemosensitivity as defined by pCR
时间窗: Up to 6 months
For neo-adjuvant chemotherapy patients the primary endpoint is pathological complete response (pCR) which is defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pearson Chi-square test.
次要结局
- Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.(Up to 6 months.)
- Compare local IHC and FISH results (if available) with TargetPrint results.(Baseline; before start of neo-adjuvant therapy.)
- Assess metastasis-free survival and relapse-free survival in molecular subgroups, determined by the established MammaPrint, BluePrint, profiles.(At -2-3 years and 5 years after definitive surgery.)
- Compare the three BluePrint molecular subgroups with IHC-based subtype classification.(Baseline; before start of neo-adjuvant therapy.)
- Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.(Baseline; before start neo-adjuvant therapy.)