ACTRN12620001212943进行中（未招募）2 期
Effect of Stereotactic Radiotherapy , on time to change in systemic therapy among women with Oligoprogressive ER-positive Breast Cancer (ER-positive, HER2-negative advanced breast cancer)
Peter Mac Callum Cancer Centre0 个研究点目标入组 32 人开始时间: 2020年11月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Male or female, 18 years of age or older
- •2.Patients with histologically proven ER-positive, HER2-negative advanced breast cancer receiving an AI in combination with a CDK 4/6 inhibitor. Biopsy of metastatic disease if technically feasible but not mandatory.
- •3.Patients must have evidence of extracranial metastatic disease with or without intracranial metastases.
- •4.Radiological evidence of stable or responding disease to an AI in combination with a CDK 4/6 inhibitor for a period of at least 6 months prior to study entry. (Patient must have ongoing stability/response in at least one lesion at the time of registration).
- •5.Evidence of new or existing OPD in 1-5 lesions. With reference to RECIST 1.132 and or PERCIST 1.033, OPD is defined as follow:
- •a.Using CT for intracranial or extracranial OPD:
- •i.greater than 5 mm increase in the diameter of an existing lesion OR
- •ii.more than 20% increase in the diameter of an existing lesion on 2 consecutive imaging studies at least 2 months apart OR
- •iii.The appearance of one or more new soft tissue lesions, measuring more than 5 mm.
- •b.Using Positron Emission Tomography for extracranial OPD:
- •i.greater than 30% increase in 18F-FDG SUV peak, with more than 0.8 SUV units increase in tumour SUV from the baseline scan in pattern typical of tumour and not of infection/treatment effect OR
- •ii.New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection.
- •6.For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ.
- •7.All OPD must be amenable to SRT.
- •a.Patients with risk of bone fracture are not candidate for SRT
- •8.For patients with intracranial metastases, SRT is the preferred treatment option, however, if clinical assessment indicated that upfront surgery is better, then post-operative SRT to the surgical cavity is recommended.
- •9.ECOG performance status 0-2.
- •10.Life expectancy of greater than 6 months.
- •11.Provision of written informed consent.
- •12.Clinician and participant are willing to continue current line of therapy.
排除标准
- •1.Pregnancy or lactation at the time of study entry.
- •2.Evidence of more than one clone of metastatic disease e.g. ER-positive and ER-negative and or HER2-positive disease. (To exclude those with some ER-positive and some TNBC or HER2-positive disease).
- •3.Evidence of Leptomeningeal disease.
- •4.Evidence of Malignant cord compression.
- •5.Previous chemotherapy for metastatic disease (chemo for primary breast cancer is allowed).
- •6.Contraindication to radiotherapy.
- •7.Previous radiotherapy in which the treated area planned to receive treatment is greater or equal to EQD2 40 Gy.
- •8.Any condition deeming the patient unsuitable to comply with the study.
研究者
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