MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Agendia
- 入组人数
- 226
- 试验地点
- 9
- 主要终点
- Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.
研究概览
简要总结
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
详细描述
Patients with suspected primary breast cancer on mammography and clinical examination will be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma.
A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel and the additional genes as measured on the whole genome (44k) array.
Surgical Protocol:
- Determination of nodal status:
- For clinically node-negative patients: Axillary ultra sound, followed by Sentinel Lymph Node (SLN) biopsy
- For clinically node-positive patients: ultra sound-guided Fine Needle Aspirate (FNA), followed by core biopsy
- Neo-adjuvant chemotherapy
- Definitive surgery:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 with histologically proven invasive breast cancer and no distant metastases and;
- •Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level.
- •Age ≥ 18 years.
- •At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response.
- •Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).
- •Signed informed consent of the patient
排除标准
- •Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
- •Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control 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.
研究组 & 干预措施
HER2 negative patients
In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include:
- TAC chemotherapy
- TC chemotherapy
- Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
干预措施: TAC chemotherapy (Drug)
HER2 negative patients
In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include:
- TAC chemotherapy
- TC chemotherapy
- Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
干预措施: TC chemotherapy (Drug)
HER2 negative patients
In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include:
- TAC chemotherapy
- TC chemotherapy
- Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
干预措施: Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy (Drug)
Her2 positive patients
The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
干预措施: TCH chemotherapy (Drug)
Her2 positive patients
The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
干预措施: T + trastuzumab followed by CEF + trastuzumab (Drug)
Her2 positive patients
The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
干预措施: Dose dense AC followed by T + trastuzumab (Drug)
Her2 positive patients
The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
干预措施: Dose dense AC followed by T + trastuzumab + pertuzumab (Drug)
Her2 positive patients
The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
干预措施: PTH followed by dose dense AC of FEC (Drug)
结局指标
主要结局
Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.
时间窗: 6-12 months
Determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR.
时间窗: 6-12 months
次要结局
- Compare TargetPrint single gene read out of ER, PR and HER2 with local and centralized IHC and/or CISH/FISH assessment of ER, PR and HER2.(Baseline. First study visit.)
- Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness.(6-9 months)
- Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy.(6-12 months)
- Compare the three BluePrint molecular subtype categories with IHC-based subtype classification.(Baseline. First study visit.)