CTIS2023-506620-87-00招募中1 期
IMPlementing geriatric assessment for dose Optimization of CDK 4/6-inhibitors in older bReasT cAncer patieNTs – a pragmatic randomized-controlled trial (IMPORTANT trial) - IMPORTANT TRIA
Region Oerebro Laen0 个研究点目标入组 495 人开始时间: 2023年8月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 495
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 65 至 65+（—）
- 性别
- All
入选标准
- •Patients male or female aged at least 70 years old at the time of informed consent. Male patients should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 14 weeks after completing therapy., Able to understand and consent in English language or in native language for each participating country., Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor = 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory., Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment., No prior systemic treatment for advanced disease (recurrence during neo-/adjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4/6-inhibitor initiation is allowed., Adjuvant treatment with CDK4/6-inhibitors is allowed provided a disease-free interval from treatment end >12 months, Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1., Written informed consent prior to any study-specific procedures., Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4/6-inhibitors that is planned to be used including ECG for assessment of QT interval before treatment with ribociclib. Specifically, the following thresholds should be used to define adequate organ function: absolute neutrophil counts of = 1,000/mm3, platelet counts of = 100,000/mm3; ALT and/or AST = 3 x upper limit normal (ULN), total bilirubin = 2 x ULN; eGFR = 30 mL/min., Able to swallow capsules.
排除标准
- •Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors., Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.Specifically, any hypersensitivity to the active substance or to any of the excipients or to peanut, soya (for ribociclib) or use of preparations containing St. John’s Wort (for palbociclib) are contraindications., Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis., History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years., Participating in other interventional trial.
研究者
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