NL-OMON53036已完成3 期
Selecting the Optimal position of CDK4/6 Inhibitors in HR+ Advanced breast cancer: the SONIA trial - SONIA
BOOG Study Center0 个研究点目标入组 1,050 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
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
- •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
- •Substudy ctDNA/pharmacogenetics & -kinetics:
- •No additional inclusion criteria
- •Substudy SONImage:
- •1. Patient is eligible and participates in the SONIA trial for ER+ advanced
- •breast cancer.
- •2. Able to give written informed consent and to comply with the SONImage
- •3. Documentation of histologically confirmed diagnosis of estrogen receptor
- •(ER) expression >10% breast cancer based on local results. The receptor status
- •can be determined on the primary tumor or on a tumor biopsy of a metastatic
- •Substudy SONIA EfFECT (cognitive testing):
- •No additional inclusion criteria.
排除标准
- •Main study:
- •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. 5. Patients treated within the last 7 days prior to randomization
- •a. Food or drugs that are known to be CYP3A4 inhibitors
- •b. Drugs that are known to be CYP3A4 inducers
- •Substudy SONImage:
- •1. Contra-indication for PET imaging.
- •2. Use of estrogen receptor ligands (i.e. tamoxifen or fulvestrant) < 5 weeks
- •before FES-PET imaging.
- •Substudy SONIA EfFECT (cognitive testing):
- •No additional exlucion criteria.
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