NL-OMON53479招募中3 期
Can molecular imaging predict outcome to firstline endocrine treatment ± CDK 4/6 inhibition in advanced ER+ breast cancer? - SONImage
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 locoregional recurrent or metastatic disease not amenable to
- •resection or radiation therapy with curative intent and for whom chemotherapy
- •is not clinically indicated.
- •2. Previously untreated with any systemic anti-cancer therapy for metastatic
- •HR+ disease, with the exception of recently started (within 14 days of start
- •treatment) 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 SONImage
- •3. Documentation of histologically confirmed diagnosis of ER expression >10%
- •breast cancer
- •based on local results (on the primary tumor or on a metastatic lesion).
- •4. Patients that are planned to start with an aromatase inhibitor + CDK 4/6
- •inhibitors within 28
- •days of signing informed consent.
- •5. Women who are not post-menopausal must receive ovarian ablation or
- •suppression with
- •administration of LHRH agonist. Postmenopausal status is defined as:
- •a. prior bilateral surgical oophorectomy, or
- •b. for patients >=60 years: spontaneous cessation of regular menses for at least
- •12 consecutive months without OAC;
- •c. for patients <60 years: spontaneous cessation of regular menses for at least
- •12 consecutive months without OAC ánd estradiol and FSH levels that meet
- •postmenopausal values according to local reference values at screening
- •6. Able to give written informed consent and to comply with the SONImage
排除标准
- •1. Contra-indication for aromatase inhibitors.
- •2. Contra-indication for PET imaging.
- •3. Use of ER ligands (i.e., tamoxifen or fulvestrant) <= 5 weeks before FES-PET
- •4. Use of CDK4/6 inhibitor before FES-PET or FDG-PET imaging.
- •5. Use of aromatase inhibitors > 2 weeks before FES-PET or FDG- PET imaging.
- •Prior to FDG/FES-PET CT imaging performed after PFS1 before start of second line
- •fulvestrant ± CDK 4/6 inhibition, the same in- and exclusion criteria apply. In
- •1. Patients must be included in SONImage at start of first line therapy.
- •2. Patients are excluded when there is a contra-indication for fulvestrant
- •3. Patients are excluded when fulvestrant is used > 2 weeks before FDG-PET
- •4. Patients are excluded when fulvestrant is used before FES-PET imaging
研究者
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