An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer (IRINA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,937
- 试验地点
- 1
- 主要终点
- Invasive Disease-Free Survival (iDFS)
研究概览
简要总结
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function Suppression (OFS) investigated in the global NATALEE trial (CLEE011O12301C, NCT 03701334) vs. tamoxifen±OFS using patients treated in German routine care as external control
详细描述
Data of premenopausal Early Breast Cancer (EBC) patients treated with tamoxifen±OFS in German routine care were used as external control for a patient-level adjusted ITC of ribociclib+NSAI+OFS vs. tamoxifen±OFS. The ribociclib+NSAI+OFS arm utilized data of premenopausal women in the NATALEE clinical trial. The tamoxifen±OFS arm as the external control used a subset of data collected in the CLEAR-B project (NCT05870813).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women between 18 and 60 years
- •HR-positive, HER2-negative EBC without distant metastases
- •Patients must belong to one of the following categories according to the American Joint Committee on Cancer (AJCC):
- •Anatomic Stage Group III,
- •Anatomic Stage Group IIB,
- •Anatomic Stage Group IIA that it either:
- •N0 with the following criteria:
- •Grade 2, with any of the following criteria:
- •Ki67 ≥ 20 % or
- •Oncotype DX Breast Recurrence Score ≥ 26 or
- •Prosigna/PAM50 categorized as high risk or
- •MammaPrint categorized as high risk or
- •EndoPredict EPclin Risk Score categorized as high risk.
- •Patients with Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor treatment other than ribociclib+NSAI+OFS were excluded
- •Patients in a bad general condition [Eastern Cooperative Oncology Group (ECOG) Status > 1] or with a limited life expectancy < 5 years were excluded
排除标准
- 未提供
结局指标
主要结局
Invasive Disease-Free Survival (iDFS)
时间窗: 96 months
Invasive Disease-Free Survival (iDFS) is defined as the time (in months) from the reference date to the date of the first contributing event and is censored otherwise. Contributing events according to the Standardized Definitions for Efficacy End Points (in Adjuvant Breast Cancer Trials) (STEEP) are * invasive ipsilateral breast tumor recurrence, * local/regional invasive recurrence, * distant recurrence, * death from BC, * death from non-BC cause, * death from unknown cause, * invasive contralateral BC, * or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin, or new in situ carcinomas of any site).
Distant Disease-Free Survival (dDFS)
时间窗: 96 months
Distant Disease-Free Survival (dDFS) is defined as the time (in months) from the reference date to the date of first contributing event. Contributing events according to the STEEP criteria are: * distant recurrence * death from BC * death from a non-BC cause * death from an unknown cause or * a second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin, or new in situ carcinomas of any site).
Recurrence-Free Survival (RFS)
时间窗: 96 months
Recurrence-Free Survival (RFS) is defined as the time (in months) from the reference date to the date of the first contributing event and censored otherwise. Contributing events according to STEEP are * invasive ipsilateral breast tumor recurrence, * local/regional invasive recurrence, * distant recurrence, * death from BC, * death from a non-BC cause, * death from an unknown cause.
Overall Survival (OS)
时间窗: 96 months
Overall survival (OS) is defined as the time (in months) from the reference date to the date of death from any cause. Time for censored patients is defined as the time from the reference date to last contact date.
Treatment Terminations (TT)
时间窗: 96 months
For the ribociclib+NSAI+OFS arm, Treatment Termination (TT) is defined as permanent treatment termination of treatment. For the tamoxifen±OFS arm, TT is defined as permanent termination of adjuvant tamoxifen.
Treatment Terminations due to Toxicity (TT_Tox)
时间窗: 96 months
For the ribociclib+NSAI+OFS arm, Treatment Termination due to Toxicity (TT_Tox) is defined as permanent treatment termination due to toxicity within three years of beginning ribociclib. For the tamoxifen±OFS arm, TT_Tox is defined as permanent treatment termination of adjuvant tamoxifen due to toxicity.
次要结局
未报告次要终点