Selecting the Optimal position of CDK4/6 Inhibitors in HR+ Advanced breast cancer: the SONIA trial - SONIA

Dutch Breast Cancer Research Group (BOOG)0 个研究点目标入组 1,050 人开始时间: 2017年8月1日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1. Adult women (= 18 years of age) with proven diagnosis of adenocarcinoma of the breast with loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
•2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer based on local laboratory results.
•3. Previously untreated with any systemic anti-cancer therapy for metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine therapy. Special considerations: a) Previous systemic treatment for locoregional recurrent disease is not an exclusion criterion, provided that the intent was curative at the time of systemic therapy. b) In case of previous systemic treatment for oligometastatic disease, patients are not eligible for SONIA.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 650

•1. Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term.
•2. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
•3. Prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor (i.e., anastrozole or letrozole) with disease recurrence while on or within 12 months of treatment.
•4. Prior treatment with any CDK4/6 inhibitor.

发起方

Dutch Breast Cancer Research Group (BOOG)