Tumor RNA Disruption Assay as a Tool to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer: Optimizing Timing of Biopsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pathologic complete response (pCR).
研究概览
简要总结
The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.
This is important because the earlier non-responders are identified, the greater is the impact of reducing side effects of ineffective treatments.
The study hypothesis is that the RDA score will accurately predict for tumor response after one cycle of chemotherapy.
详细描述
This prospective clinical trial will determine if the tumor RDA score can predict for pCR after the first, second, and third cycles of chemotherapy in women with breast cancer treated with neoadjuvant therapy. Tumor RDA score will also be measured after the first dose of any new chemotherapy agent if residual palpable disease is present.
Data will be collected until accrual target of 30 patients is met. All patients will undergo core needle biopsy of the breast tumor and analysis of ER, PR, and HER-2-Neu receptors. Patients will receive neoadjuvant therapy as recommended by their treating physicians. All chemotherapy regimens will be acceptable for participation in this study. Usually, these regimens are between 6 to 8 cycles, often with a switch of chemotherapy regimens after 3 to 4 cycles.
Evaluation of tumor size will be determined by 2 axis tumor measurement performed prior to, and after each chemotherapy treatment. The Tumor RDA score will be evaluated by performing fine needle aspiration (FNA) biopsies under local anesthetic, if the tumor is clinically palpable, after the first, second, and third cycles of chemotherapy. Tumor RDA score will also be determined if palpable tumor is present after the first cycle of any second chemotherapy agent.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be female.
- •Patients must be 18 years of age or older.
- •Patients with stage I, II, or III breast cancer that is greater or equal to 2 cm on clinical examination.
- •Patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy
- •Patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer.
- •Patients that accept to undergo neoadjuvant chemotherapy.
- •Patients with bilateral breast cancer are eligible.
- •Patients that understand, accept, and have signed the approved written consent form.
- •Patients will need to consent to be part of the study.
排除标准
- •Patients with one or more of the following conditions are ineligible for this study:
- •Patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer
- •Patients who are pregnant or breast feeding.
- •Psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.
结局指标
主要结局
Pathologic complete response (pCR).
时间窗: At time of surgery (4-8 months after first dose of neoadjuvant therapy).
Determine the optimal time at which Tumor RNA Disruption Assay (RDA) can predict pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.
次要结局
未报告次要终点
研究者
Jean-Fancois Boileau
Surgical Oncologist and Clinician-Researcher
Jewish General Hospital