NL-OMON54479招募中2 期
COntinue the SaMe systemic therapy after local ablative therapy for Oligo progression in metastatic breast cancer - the COSMO study - COSMO
ederlands Kanker Instituut0 个研究点目标入组 118 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •o Histologically confirmed infiltrating breast cancer
- •o MBC according to TNM-staging
- •o Oligoprogression defined as one or two distant metastatic lesions, limited to
- •o Oligoprogression should occur during first- or second-line systemic therapy
- •o Patients should be on systemic therapy for at least 6 months without prior
- •evidence of progressive disease.
- •o Lesion(s) must be amenable to resection, radiotherapy or percutaneous
- •ablation with the intent of local obliteration.
- •o Age >=18
- •o World Health Organization (WHO) Performance Status 0 or 1
- •o Signed written informed consent before patient registration according to
- •ICH/GCP, and national/local regulations
排除标准
- •o Having received more than two lines of systemic therapy for MBC
- •o Prior or concurrent other invasive malignancy except basal 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
- •o Current pregnancy or breastfeeding. Women of childbearing potential must use
- •adequate contraceptive protection
- •o Presence of any medical condition that would place the patient at unusual risk
- •o Presence of any psychological, familial, sociological, or geographical
- •condition potentially hampering compliance with the study protocol and
- •follow-up schedule
研究者
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