NCT00161265已完成不适用
UMCC 2004.064: Tissue Procurement Protocol for Patients Undergoing Neoadjuvant Systemic Therapy for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
研究概览
简要总结
This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.
详细描述
This protocol will provide a systematic approach to obtaining, cataloging, and distributing research tissue and blood from patients who will receive neoadjuvant systemic therapy for localized breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
- •The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
- •The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
- •Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
- •All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.
排除标准
- •Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
- •Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
- •Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
- •Patients with another active systemic malignancy in the past year.
研究者
研究点 (1)
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