2024-520290-12-00尚未招募4 期
TYPER– A Randomized Controlled Study Evaluating the Effectiveness of Typology-based Coaching on Therapy Management for Patients with HR+ HER2- Early Breast Cancer Under Adjuvant Treatment with Ribociclib
Institut fuer Frauengesundheit GmbH15 个研究点 分布在 1 个国家目标入组 548 人开始时间: 2025年8月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 548
- 试验地点
- 15
- 主要终点
- time to permanent treatment discontinuation of ribociclib therapy
研究概览
简要总结
The primary objective of this study is to evaluate the effect of patient education and typology-based coaching on treatment persistence. The primary endpoint will be the time to permanent treatment discontinuation of ribociclib therapy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Trial Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant provides written informed consent prior to the beginning of trial-specific procedures
- •Patients must be aged ≥18 years on the day of signing informed consent
- •Participant has histologically confirmed primary invasive adenocarcinoma of the breast
- •Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or progesterone receptor–positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory
- •Participant has HER2neg breast cancer defined as a negative ISH test or an IHC status of 0, 1+, or 2+. If the IHC is 2+, a negative ISH (e.g., FISH, CISH, SISH, or DISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample
- •Indication for treatment with ribociclib in combination with an aromatase inhibitor for early breast cancer according to the valid SmPC
- •Participant has adequate organ function amenable for treatment with ribociclib as assessed by a local laboratory
- •Female participants of childbearing potential must have had a hysterectomy or be willing to use highly effective methods of contraception and have a confirmed negative pregnancy test as assessed by local in-house standard
- •Participant is willing and able to comply with scheduled visits, treatment plans, and other trial procedures
排除标准
- •Patients with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery
- •Patients with serious preexisting medical condition(s) that would preclude participation in this study
- •Women who are pregnant or lactating
- •Patients with active bacterial infections (requiring IV antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (e.g., known human immunodeficiency virus positivity or known active hepatitis B or C, such as hepatitis B surface antigen–positive])
- •Patients with a personal history in the past 5 years of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
- •Patients with contraindications against ribociclib according to the current SmPC
- •Patients with hypersensitivity to active substance of ribociclib, peanuts, soya or one of the other ingredients
- •Patients who are not eligible for the trial due to severe comorbidities other than those mentioned above or unavailability according to the treating physician
结局指标
主要结局
time to permanent treatment discontinuation of ribociclib therapy
time to permanent treatment discontinuation of ribociclib therapy
次要结局
- overall persistence rate at 6, 12 and 36 months of adjuvant ribociclib therapy
- relapse- and death-free discontinuation rate at 6,12 and 36 months of adjuvant ribociclib therapy
- total time of therapy interruptions within 36 months of ribociclib treatment, surveyed by a patient diary
- distress and quality of life assessed via the Functional Assessment of Cancer Therapy—Breast (FACT-B), the EQ-5D/visual analog scale (VAS) questionnaires, and the patient distress thermometer after 3, 6, 9, 12, 24, and 36 months of treatment
- frequency of adverse events (AEs) (serious AEs (SAEs) will be reported according to National Cancer Institute (NCI) Common Toxicity Criteria version 5.0)
- outcomes according to STEEP 2.0 criteria
- required health utilities within 12, 24 and 36 months
- patient type before coaching and after 12 months of coaching
研究者
Clinical Trial Team
Scientific
Institut fuer Frauengesundheit GmbH
研究点 (15)
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