NCT05478590已完成不适用
HR POSITIVE, HER 2 NEGATIVE ADVANCED BREAST CANCER- TREATMENT PATTERNS IN POLAND - HABER STUDY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 440
- 试验地点
- 37
- 主要终点
- Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns
研究概览
简要总结
The study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in Poland in the real-world data setting. The main goals are to assess the current treatment patterns of hormone receptor-positive (HR+) Human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer and their changes in clinical practice and relate them to patients' demographics, disease characteristics, type of other therapies used in patients as well as disease progression and visceral crisis occurrence.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with histologically diagnosed advanced breast cancer (with locoregional recurrence not eligible for radical local treatment or with distant metastases)
- •Patient has a documented hormone (estrogen and/or progesterone) receptor expression and lack of HER2 receptor overexpression or lack of HER2 gene amplification (HR+/HER2- breast cancer subtype)
- •Patient had no prior treatment for advanced breast cancer
- •Patient has no symptomatic metastases to the central nervous system
- •There is no other malignancies in patient requiring active treatment
- •Patient is without co-occurring other malignancies treated with palliative assumption
排除标准
- •Parallel patient's participation in any other clinical trial at the time when the decision over the advanced breast cancer treatment was made or up to 30 days before it.
结局指标
主要结局
Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns
时间窗: 01 September 2020 through 31 August 2021
次要结局
- Clinical Characteristics of Treated BC Participants(01 September 2020 through 31 August 2021)
- Correlation of Treatment Patterns With the Reference of the si.+-te Defined by Number of Enrolled Patients(01 September 2020 through 31 August 2021)
- Demographical Characteristics of Participants(01 September 2020 through 31 August 2021)
- Treatment Modalities of Adjuvant Therapies Early BC(01 September 2020 through 31 August 2021)
- Number of Changes in Clinical Practice During One Year Observational Period in Relation to the Local Breast Cancer (BC) Treatment Guidelines(01 September 2020 through 31 August 2021)
- Treatment Modalities of Neoadjuvant Therapies Early BC(01 September 2020 through 31 August 2021)
- Time to Disease Free Interval(01 September 2020 through 31 August 2021)
- Number of Participants With Association Between Disease Characteristic and ABC Treatment Patterns(01 September 2020 through 31 August 2021)
- Number of Participants With Association Between Clinical Characteristic and ABC Treatment Patterns(01 September 2020 through 31 August 2021)
- Number of Participants With Association Between Concomitant Therapy and ABC Treatment Patterns(01 September 2020 through 31 August 2021)
- Number of Participants With Association Between Time to Relapse in early BC Treatment and ABC Treatment Patterns(01 September 2020 through 31 August 2021)
- Proportion of Participants With Diagnosed Visceral Crisis(01 September 2020 through 31 August 2021)
- Number of Participants With Association Between Adjuvant Therapy and ABC Treatment Patterns(01 September 2020 through 31 August 2021)
- Number of Visceral Crisis Diagnosis in Compliance With ABC5 Guidelines(01 September 2020 through 31 August 2021)
- Correlation of Treatment Type to Demographical Characteristics of Participants(01 September 2020 through 31 August 2021)
- Disease Characteristics of Treated BC Participants(01 September 2020 through 31 August 2021)
- Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns(01 September 2020 through 31 August 2021)
研究者
研究点 (37)
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