NCT05933733招募中不适用
A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate clinical outcomes and adverse events of salvage treatment for locoregional recurrence of breast cancer.
The main questions it aims to answer are:
- Clinical outcomes after salvage treatment for locoregional recurrence
- Adverse events and quality of life after salvage treatment for locoregional recurrence
- Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events
- Molecular signature associated with treatment resistance
Participants will be assessed by multi-dimensional methods during and after radiation therapy:
- Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
- Assessment for the adverse events according to CTCAE version 5.0
- Assessment for the molecular signature using residual tissue after pathologic diagnosis
- Assessment for the quality of life using questionnaires (BREAST-Q)
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with age 18 to
- •Previous standard definitive treatment for initial breast cancer
- •Locoregional recurrence without distant metastasis
- •Planned salvage treatment for locoregional recurrence
- •Informed consent of the participant
排除标准
- •Not anticipated for complying the study protocol
结局指标
主要结局
Progression-free survival
时间窗: 5 years from the initiation of the salvage therapy
The event for progression-free survival was defined as any disease progression or breast cancer-related death.
Rate of adverse events
时间窗: 5 years from the initiation of the salvage therapy
Adverse events related to the salvage therapy will be reported and incidence rate will be calculated.
次要结局
- Cancer-specific survival(5 years from the initiation of the salvage therapy)
- Breast cosmesis(5 years from the initiation of the salvage therapy)
- Locoregional failure rate(5 years from the initiation of the salvage therapy)
- Quality of life (BREAST-Q)(5 years from the initiation of the salvage therapy)
研究者
Haeyoung Kim
Associate Professor
Samsung Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal CancerRectal CancerNCT01296984Sahlgrenska University Hospital, Sweden1,319
招募中
不适用
Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related TherapiesHematopoietic and Lymphoid Cell NeoplasmMalignant Solid NeoplasmNCT05108519M.D. Anderson Cancer Center170
已完成
不适用
Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related IllnessPediatric or Young Adult Cancer SurvivorsNCT01667952Memorial Sloan Kettering Cancer Center1,068
招募中
不适用
Chronic Toxicities Related to Treatment in Patients With Localized CancerBreast Cancer Nos Metastatic RecurrentEarly Lung CancerNCT01993498UNICANCER14,750
终止
不适用
A Prospective Study of Clinical Outcomes for the Pathwork Tissue of Origin TestNeoplasm MetastasisNCT01649453Cedar Associates LLC19