Adherence and Safety of Ribociclib Plus Aromatase Inhibitors in Patients With Early Stage, Hormonal Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
Breast cancer is the most common malignancy in women, with HR+/HER2- early breast cancer accounting for approximately 70% of cases. Although adjuvant endocrine therapy substantially reduces the risk of recurrence, a clinically meaningful proportion of patients, particularly those with intermediate- and high-risk disease, still experience relapse. The addition of CDK4/6 inhibitors such as ribociclib to endocrine therapy has demonstrated significant improvement in invasive disease-free survival (iDFS) and is now part of standard adjuvant treatment for selected patients. However, the real-world effectiveness of prolonged oral therapy depends heavily on patient adherence, which may be negatively affected by treatment duration, adverse events, and the absence of immediate perceived benefit. Evidence regarding adherence to adjuvant ribociclib therapy in routine clinical practice remains limited. This study therefore aims to evaluate whether a structured adherence-support intervention can improve treatment adherence during ribociclib therapy and to explore the relationship between adherence and long-term clinical outcomes, including iDFS.
详细描述
Breast cancer (BC) is the most prevalent malignant tumour in women, with an estimated 2.308 million new cases and over 665,000 deaths globally in 2022. Around 90% of patients are diagnosed at an early stage and the majority of these cases, approximately 70%, are hormone receptor-positive and HER2-negative (HR+/HER2-).
Despite advancements in adjuvant endocrine therapy that significantly lower recurrence and mortality rates, 20-30 % of early-stage BC patients experience relapse within the first decade post-surgery. Around 12% of patients with HR+/HER2- BC belong to high-risk population with 5-years invasive disease-free survival (IDFS) of 70.2% vs 90.0% in non-high-risk. In the large EBCTCG meta-analysis which included 62,923 women with ER-positive early breast cancer who completed 5 years of adjuvant endocrine therapy, the risk of distant recurrence remained substantial over the subsequent 15 years and was strongly dependent on initial tumour size and nodal status.
Among patients with T1 tumours, 13-34% experienced distant recurrence during years 5-20, whereas 19-24% of those with T2 tumours relapsed over the same period, depending on nodal burden and tumour grade. These findings delineate an intermediate-risk group within HR+/HER2- early breast cancer-patients with T1-2, node-negative or limited node-positive disease-who, despite not meeting conventional "high-risk" criteria, still face a clinically meaningful long-term risk of recurrence after standard endocrine therapy. This persistent residual risk highlights the unmet need for improved risk stratification tools and additional adjuvant strategies to optimize outcomes in this intermediate-risk population.
The most recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 4/6 inhibitors (CDK4/6 inhibitors).
Endocrine therapy combined with CDK4/6 inhibitors (abemaciclib, palbociclib and ribociclib) is now the standard, most effective, and recommended treatment for these patients in the first or subsequent lines of treatment for advanced disease. Two CDK4/6 inhibitors, abemaciclib and ribociclib, have been assessed also for use in the adjuvant setting (MonarchE and NATALEE study). Both studies showed improvement in iDFS of combined endocrine therapy and CDK4/6 inhibitor vs endocrine therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patient prescribed with ribociclib in combination with an aromatase inhibitor independently of trial participation
- •Patient was prescribed ribociclib independently of this trial protocol and has not yet started cycle 1
- •Patient is ≥ 18 years-old at the time of ICF signature
- •Patient has mandatory Slovenian health insurance
- •Patient understands and speaks Slovenian language and is of congitive capability to participate in the trial
- •Patient has access to phone
- •Patient voluntarily agrees to participate in the trial and provides written ICF
排除标准
- •Patient is not treated with the combination of ribociclib and aromatase inhibitor for Early BC
- •Metastatic Hormone Receptor positive and HER2- negative BC
- •Any medical condition that, in the opinion of the investigator, would interfere with adherence participation in the trial (i.e. significant cognitive impairment, psychiatric condition)
- •Language barrier that precludes informed consent or meaningful participation in the adherence intervention