Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,766
- 试验地点
- 41
- 主要终点
- Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort
研究概览
简要总结
This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.
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
- •Patients from the prospective cohort of the study must meet all of the following criteria:
- •Signed and dated Informed Consent Form (ICF) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±GnRH agonists).
- •Age ≥18 years at the time of signing the ICF.
- •Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
- •The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib.
- •ECOG performance status 0-1
- •Patients from the retrospective cohort of the study must meet all of the following criteria:
- •Age ≥18 years at the initiation of hormone therapy.
- •Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
- •Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1,
- •Presence of the necessary information in the source documentation.
排除标准
- •Patients enrolled in the study in prospective cohort should not meet any of the following criteria.
- •History of therapy with abemaciclib or palbociclib
- •Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form
- •Active therapy for other malignant neoplasms
- •Participation in interventional clinical studies at the time of signing the Informed Consent Form
- •Patients enrolled in the study in retrospective cohort should not meet any of the following criteria.
- •Neoadjuvant or adjuvant therapy with CDK4/6 inhibitors
- •A history of another concomitant malignant neoplasm requiring active therapy
- •Participation in interventional clinical studies at the time of treatment for breast cancer
- •Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.
研究组 & 干预措施
Ribociclib+AI
Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant ribociclib plus AI (aromatase inhibitor)
干预措施: Ribociclib (Drug)
Ribociclib+AI
Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant ribociclib plus AI (aromatase inhibitor)
干预措施: Letrozole (Drug)
Ribociclib+AI
Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant ribociclib plus AI (aromatase inhibitor)
干预措施: Anastrozole (Drug)
Monotherapy AI
Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant AI (aromatase inhibitor) monotherapy
干预措施: Letrozole (Drug)
Monotherapy AI
Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant AI (aromatase inhibitor) monotherapy
干预措施: Anastrozole (Drug)
结局指标
主要结局
Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort
时间窗: Months 36, 48, 60
IBCFS at M36, M48, and M60 according to the STEEP 2.0 criteria in a prospective cohort (defined as the time from the start of therapy to one of the listed events: ipsilateral invasive recurrence of breast cancer, locoregional invasive recurrence, distant recurrence, breast cancer-related death, death not associated with breast cancer progression, death from unknown cause, contralateral invasive recurrence of breast cancer) depending on the tumor grade (G2/G3) and the status of lymph node involvement (N0/N1/N2-3)
次要结局
- Invasive breast cancer-free survival in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).(Months 36, 48, 60)
- Invasive disease-free survival (IDFS) in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).(Months 36, 48, 60)
- Recurrence-free survival (RFS) in the prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).(Months 36, 48, 60)
- Number of doses taken relative to the total planned doses of ribociclib %(Months 36)
- Number of participants with AEs/SAEs including those of special interest, in patients receiving ribociclib(Months 3, 6, 9, 12, 24, 36)
- Number of patients who discontinued ribociclib for any reason, due to any AE, and due to AEs of special interest(Months 3, 6, 9, 12, 24, 36)
- Patients' quality of life evaluated through a questionnaire(Months 3, 6, 9, 12, 24, 36, 48, 60)