Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Invasive Breast Cancer-Free Survival (iBCFS)
研究概览
简要总结
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.
详细描述
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.
The study aims to recruit 177 patients who have been newly receiving ribociclib for up to 6 months prior to enrollment date, as per the locally approved label to which the physician has made an independent decision to prescribe ribociclib. Patients will be enrolled over a recruitment window of 9 months and will be followed up for 36 months to assess the study outcomes. It is planned to capture data at the following timepoints (+/- 1 month): Baseline, 3, 6, 12, 24, and 36 months. This is in line with the frequency of routine follow-up visits, per standard of care.
Data will be collected from patients' electronic medical records in the selected sites. The planned number of sites is 6, to be selected based on feasibility reports, considering the patient pool and research capabilities.
Participating sites' investigators will review all the available clinical files of patients whose ribociclib treatment decision has been made by their treating physician and will invite those who fulfill the eligibility criteria to participate in the study. Data will be entered into an electronic case report form (eCRF). All patients' data will remain anonymized, fulfilling the requirements of data protection. Data collected will include information on previous treatments received, disease history, and current treatment patterns and outcomes.
Participation in the study is not intended to change the routine treatment patients receive as determined by their treating physicians; all therapeutic decisions, as well as the type and timing of disease monitoring, will be at the discretion of the treating physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated Patient Informed Consent Form (PICF) obtained.
- •The patient is ≥ 18 years-old at the time of PICF signature.
- •Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
- •Male or female patients with HER2- BC.
- •Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date.
- •Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) /IIB or Anatomic Stage Group III EBC.
- •Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male.
排除标准
- •Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
- •Patients are currently participating in any other clinical trials.
- •Patients who previously received any other CDK4/6 inhibitor.
- •Patients who refused to sign informed consent.
- •According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reason.
研究组 & 干预措施
Ribocliclib
HR+/HER2- early breast cancer patients who have been newly receiving ribociclib for up to 6 months prior to enrollment
干预措施: ribociclib (Drug)
结局指标
主要结局
Invasive Breast Cancer-Free Survival (iBCFS)
时间窗: 36 months
iBCFS, defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or invasive contralateral BC. iBCFS will be assessed using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant BC Clinical Trials), as assessed by the investigator, in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
次要结局
- Invasive disease free survival (iDFS)(Up to 36 months)
- Distant disease free survival (DDFS)(Up to 36 months)
- Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(36 months)
- Change from baseline in the physical functioning sub-scale score and global health status/QoL scale score as assessed by EORTC QLQ-C30(36 months)
- Demographics - Age(Baseline)
- Demographics - Gender, race, region(Baseline)
- Clinical characteristics - menopausal status(Baseline up to 36 months)
- Clinical characteristics - anatomical stage(Baseline up to 36 months)
- Clinical characteristics - pre-index chemotherapy and concomitant medication(Baseline up to 36 months)
- Clinical characteristics - medical history(Baseline up to 36 months)