Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Invasive disease-free survival (iDFS)
研究概览
简要总结
This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life [HRQoL], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.
详细描述
This will be a multi-center, multi-country, observational, non-interventional, hybrid study among HR+/HER2- stage II or III eBC patients treated with ribociclib + ET or abemaciclib + ET, as per local label in routine clinical care settings.
The study will include a retrospective and a prospective part. The hybrid design will combine retrospective data extraction from patients' EHRs and prospective data collection from validated PRO questionnaires, bespoke questions, and qualitative interviews, to provide comprehensive data on the patient population.
The exploratory objectives will assess HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET. No formal comparison between the cohorts will be made
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Males or females.
- •Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx).
- •Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.
- •Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.
- •Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).
- •Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:
- •Tested positive for estrogen receptor (ER+), or
- •Tested positive for progesterone receptor (PR+), or
- •Tested positive for both.
- •Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.
排除标准
- •Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date.
- •Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period.
- •Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.
研究组 & 干预措施
Ribociclib arm
Patient treated with ribociclib and Endocrine Therapy (ET) per standard of care
Abemaciclib arm
Patient treated with abemaciclib and Endocrine Therapy (ET) per standard of care
结局指标
主要结局
Invasive disease-free survival (iDFS)
时间窗: 36 months
iDFS is defined as time to first invasive breast cancer recurrence (ipsilateral, contralateral, local/regional, distant), new primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.
Distant disease-free survival (DDFS)
时间窗: 36 months
Distant disease-free survival (DDFS) is defined as time to first distant recurrence, second primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause. This will be assessed based on STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) and collected retrospectively from patient chart.
次要结局
- Number of participants by treatment patterns assessed in both the adjuvant and metastatic settings(From index date until death, lost to follow-up, end of study period, or enrollment in clinical trials, whichever occurs first. The maximum follow-up time is expected to be up to 54 months)
- Persistence to ribociclib + ET(Up to approximately 36 months)
- Distant disease-free survival(At 12, 24 and 36 months)
- Overall survival(At 12, 24 and 36 months)
- Distant recurrence-free survival(At 12, 24 and 36 months)
- Invasive disease-free survival(At 12, 24 and 36 months)
- Patient and tumor characteristics at/around recurrence for HR+/HER2- stage II and III eBC patients treated with ribociclib + ET.(From index date until death, lost to follow-up, end of study period, or enrollment in clinical trials, whichever occurs first. The maximum follow-up time is expected to be up to 54 months)
- AEs affecting HR+/HER2- stage II and III eBC patients treated with ribociclib + ET(Every 6 months until death, lost to follow-up, end of study period, or enrollment in clinical trials, whichever occurs first. Up to approximately 54 months)
- Adherence to ribociclib + ET assessed using the MARS-5 tool(Up to approximately 36 months)
- Treatment satisfaction with ribociclib + ET assessed using bespoke questions.(Up to approximately 36 months)
- Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-C30.(Up to approximately 36 months)
- Adherence to ribociclib + ET assessed using bespoke questions.(Up to approximately 36 months)
- Changes in Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using EORTC QLQ-BR42.(Up to approximately 36 months)
- Work productivity measured using WPAI(Up to approximately 36 months)
- Work productivity in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET using bespoke questions.(Up to approximately 36 months)
- Changes in Long Term Health Related Quality of Life (HRQoL) with ribociclib + ET assessed using bespoke questions.(Up to approximately 36 months)
- Patients' experience of treatment in HR+/HER2- stage II and III eBC patients treated with ribociclib + ET(Up to approximately 12 months)
- Invasive breast cancer-free survival(At 12, 24 and 36 months)