NCT05959291招募中不适用
Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of maintaining remission after discontinuing use of anti-HER-2
研究概览
简要总结
The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of HER-2 positive metastatic (Stage IV) breast cancer.
- •Patients in complete radiological remission (CRR), including a stable bone scan, as determined by computed tomography (CT), positron-emission tomography (PET), or PET-CT.
- •a. Patients with brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months.
- •Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months.
- •Archived tumor biopsy available.
- •Patients with no evidence of circulating tumor deoxyribonucleic acid (ctDNA) as determined by the Signatera assay.
- •Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring.
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to
- •Patients ≥ 18 years of age.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with uncontrolled metastatic disease.
- •Patients whose disease has been controlled for less than 36 months on the same or current anti-HER-2 therapy.
- •Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions or in situ cancer within the past 24 months.
- •Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.
- •Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the Investigator.
- •Patients with impaired decision-making capacity.
- •Patients who are found to be ctDNA+ at study entry will be recorded as a screen failure (Section 5.4). Their Signatera testing results will be provided to their treating physician to aid in clinical decision-making for disease management and treatment.
结局指标
主要结局
Feasibility of maintaining remission after discontinuing use of anti-HER-2
时间窗: Up to 72 months
The feasibility of maintaining remission of HER-2 will be measured as the proportion of patients who discontinue anti-HER-2 therapy and who remain in remission is assessed by monitoring ctDNA in the blood.
次要结局
- Ability of re-attain remission after ctDNA+ status(Up to 72 months)
- Duration of response (DOR)(Up to 72 months)
- Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression(Up to 72 months)
研究者
Elisa Krill Jackson
Staff Physician
University of Miami
研究点 (2)
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