REal-world Patterns of Treatment With CDKi 4/6 for AdVanced BrEast CAncer in PortugaL - REVEAL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Mean Age
研究概览
简要总结
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in Portugal. This was a study of medication use patterns, based on information from the hospital pharmacies of the participating centers.
Patients who started a CDKi 4/6 (ribociclib or palbociclib) between 1 March 2019 and 31 December 2019 were included and followed through 24 months. A follow-up occurred 6 months after the start of CDKi 4/6 (ribociclib or palbociclib) to quantify the occurrence of dose changes.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older at the time of starting therapy with CDKi 4/
- •Breast cancer diagnosis.
- •At least one record of ribociclib or palbociclib donation during the identification period.
- •Registration of the first supply of ribociclib or palbociclib between 1 March 2019 and 31 December 2019.
排除标准
- •Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.
结局指标
主要结局
Mean Age
时间窗: Baseline, defined as start of treatment with CDKi
Initial Dose of CDKi 4/6
时间窗: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients by CDKi 4/6
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Patients Without Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor
时间窗: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Patients Starting First-Line Therapy with CDKi 4/6
时间窗: Baseline, defined as start of treatment with CDKi
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Number of Patients Starting Second-Line Therapy with CDKi 4/6
时间窗: Baseline, defined as start of treatment with CDKi
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Number of Palbociclib-treated Patients by Type of Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients Without Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause Patients Without Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause Patients by CDKi 4/6
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day
时间窗: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Pre-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor
时间窗: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
时间窗: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
次要结局
- Average Number of Dose Changes Per Patient(Up to 6 months post-initiation of CDKi treatment)
- Number of Ribociclib-treated Patients by Number of Dose Changes(Up to 6 months post-initiation of CDKi treatment)
- Number of Patients with at Least One Dose Change(Up to 6 months post-initiation of CDKi treatment)
- Number of Palbociclib-treated Patients by Number of Dose Changes(Up to 6 months post-initiation of CDKi treatment)