NCT06833502招募中2 期
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Systemic Metastasis
研究概览
简要总结
The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.
- •HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines
- •Triple negative will be classified as ER and PR <10% and HER2-.
- •Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.
- •Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients.
- •Life expectancy ≥ 6 months.
- •Eastern Cooperative Oncology Group performance status 0 to
- •Patients must be able to understand and the willingness to sign an informed consent for study procedures.
- •Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •Prior diagnosis of systemic metastases.
- •Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.
- •Contraindication towards CT IV contrast.
- •Chronic kidney disease stage IV or V or end stage renal disease (CrCl <30 ml/min).
研究组 & 干预措施
Triple negative
Other
Participants diagnosed with triple negative breast cancer.
干预措施: CT Scan (Other)
HER2+
Other
Participants diagnosed with HER2+ breast cancer.
干预措施: CT Scan (Other)
Hormone receptor (HR)+
Other
Participants diagnosed with hormone receptor (HR)+ breast cancer.
干预措施: CT Scan (Other)
结局指标
主要结局
Systemic Metastasis
时间窗: Baseline and 6 months
Proportion of participants with systemic metastasis at baseline and 6 months.
次要结局
- Metastasis Treatment(Up to 12 months)
- Metastasis Frequency(Up to 12 months)
研究者
研究点 (1)
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