COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 11
- 主要终点
- Number of patients free of progression at 6 months
研究概览
简要总结
Patients with oligoprogression of metastatic breast cancer during palliative treatment that is amenable to local therapy will be included. The local ablative therapy (LAT) may consist of stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy, surgery or percutaneous ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Histologically confirmed invasive breast cancer
- •Metastatic breast cancer
- •o Oligoprogression is defined as an increase of ≥20% in size or, in case of FDG-PET-CT, metabolic activity (≥20% in SUVmax) involving a maximum of two lesions. These lesions may consist of: 1 or 2 distant metastatic lesions limited to 1 organ, the primary tumor or locoregional lymph nodes.
- •Systemic treatment can be either endocrine, targeted, chemotherapy or immune-checkpoint blockade
- •Patients should be on systemic therapy for at least six months. Status should be stable disease or partial or complete response for at least 6 months.
- •Oligoprogression has to be detected with radiological imaging comparing the lesion on the same type of imaging modality as has been used at the start of systemic therapy.
- •Lesion(s) must be amenable to resection, radiotherapy or percutaneous ablation with the intent of local obliteration.
- •The radiological imaging that shows progression must be performed within 70 days prior to LAT.
- •Bone metastases are classified as progressive if the lytic component of the lesion increases by ≥20% or the FDG-uptake increases by ≥20% on FDG-PET-CT
- •Lymph nodes should be larger than 15 mm upon first detection of oligoprogression to be classified as progressive.
- •Oligo-progression has to be confirmed with a FDG-PET-CT-scan 5-7 weeks after the initial scan that showed oligoprogression.
- •World Health Organization (WHO) Performance Status 0 or 1
- •Signed written informed consent before patient registration according to ICH/GCP, and national/local regulations
排除标准
- •Having received more than two lines of systemic therapy for MBC If a treatment regimen has been de-escalated without adding other therapies, this is seen as one line of therapy. For example: Pertuzumab/trastuzumab+docetaxel followed by pertuzumab/trastuzumab will be viewed as one line of systemic therapy.
- •Other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy
- •Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- •Presence of any medical condition that would place the patient at unusual risk, up to the discretion of the clinician
- •Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究组 & 干预措施
Surgery, radiotherapy or radiofrequent ablation
The oligoprogresive lesion(s) will be treated with Surgery, radiotherapy or percutaneous ablation depending on the location of the lesion. treatment will be standard of care and will be decided by the treating team of the patient.
干预措施: Surgery (Procedure)
Surgery, radiotherapy or radiofrequent ablation
The oligoprogresive lesion(s) will be treated with Surgery, radiotherapy or percutaneous ablation depending on the location of the lesion. treatment will be standard of care and will be decided by the treating team of the patient.
干预措施: Radiotherapy (Radiation)
Surgery, radiotherapy or radiofrequent ablation
The oligoprogresive lesion(s) will be treated with Surgery, radiotherapy or percutaneous ablation depending on the location of the lesion. treatment will be standard of care and will be decided by the treating team of the patient.
干预措施: Radiofrequent ablation (Other)
结局指标
主要结局
Number of patients free of progression at 6 months
时间窗: At 6 months
progression-free survival at 6 months (PFS-6)
次要结局
- Number of patients who develop "visceral crisis"(Up to 120 months)
- Number of patients free of progression at 6 months per localization of progressive lesion(At 6 months)
- Overall Surival (OS)(Up to 120 months)
- Number of patients who develop complications after local ablative treatment(Up to 120 months)
- Number of patients free of progression at 6 months per histoligical subtype(At 6 months)
- Time to next line of treatment(Up to 120 months)
- Number of patients free of progression at 6 months per breast cancer subtype(At 6 months)