Axillary Lymph Nodes and PET (Positron Emission Tomography) Probe-Guided Surgical Resection in Locally Advanced Breast Cancer Patients: Molecular Marker Profile and Response to Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Improved breast conservation rates in neoadjuvant patients
研究概览
简要总结
RATIONALE: Comparing results of diagnostic procedures, such as molecular marker profiling, done before and after chemotherapy, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well molecular marker profiling of axillary lymph nodes works in predicting response in patients with locally advanced or metastatic breast cancer who are undergoing chemotherapy followed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine whether molecular markers in pretreatment axillary lymph node metastases can predict pathologic response to neoadjuvant chemotherapy in patients with locally advanced or early metastatic breast cancer.
Secondary
- Compare molecular markers in axillary lymph node metastases with those in the primary breast tumor (obtained in protocol UNC-LCCC-9819) in patients treated with neoadjuvant chemotherapy.
- Determine changes in molecular markers in lymph nodes before and after treatment with neoadjuvant chemotherapy in these patients.
- Determine the proportion of clinical axillary lymph node-negative patients who have histopathologically node-positive disease identified by sentinel lymph node biopsy.
- Determine the rate of breast preservation in patients with large breast cancers treated with neoadjuvant chemotherapy followed by fludeoxyglucose F 18 positron emission tomography probe-guided surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive breast cancer by fine needle aspiration or biopsy
- •Locally advanced or early metastatic disease
- •Clinically or radiographically measurable disease
- •Planning to receive neoadjuvant chemotherapy for locally advanced or early metastatic disease
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Not specified
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for this malignancy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
PET negative
Traditional breast Surgery and full axillary dissection
干预措施: PET (positron emission tomography) (Procedure)
PET positive
PET-probe-guided breast resection and full axillary dissection
干预措施: PET (positron emission tomography) (Procedure)
结局指标
主要结局
Improved breast conservation rates in neoadjuvant patients
时间窗: 12 weeks
Determine if an intraoperative positron emission tomography (PET) probe can improve breast conservation rates in patients treated initially with neoadjuvant chemotherapy by at least 2%.
次要结局
未报告次要终点