NCT05034393已完成不适用
Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 15
- 主要终点
- The proportion of type of first-line treatment
研究概览
简要总结
This study aims to describe in detail the patient journey from diagnosis to the beginning of treatment and patterns of care of hormone receptor- positive, HER2-negative de novo or recurrent metastatic breast cancer between January 2018 and December 2020 in Brazil.
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
- •Women ≥18 years old
- •Histologically confirmed hormone receptor-positive HER2-negative invasive breast cancer
- •Hormone receptor-positive defined as 1% to 100% of tumor nuclei positive for Estrogen - - Receptor and/or Progesterone Receptor, as per ASCO/CAP Guideline 2020 - or Allred score of ≥3
- •HER2-negative defined as IHC result is 0/1+ or 2+ with ISH negative as per ASCO/CAP Guideline 2018
- •Diagnosed with de novo or recurrent metastatic breast cancer between January 2018 -and December 2020
- •Public health system or private health system
排除标准
- •Male Breast Cancer
- •First-line treatment for mBC received through clinical trial
结局指标
主要结局
The proportion of type of first-line treatment
时间窗: from January 2018 to December 2020
次要结局
- The PFS, defined as time from treatment start until progression (by image or physical exam) or death(from January 2018 to December 2020)
- First-line treatment according to the drug name by type of health care coverage (public vs private)(from January 2018 to December 2020)
- The PFS will be evaluated by type of health care coverage (public vs private).(from January 2018 to December 2020)
- Timeline from first symptom to diagnosis(from January 2018 to December 2020)
- Timeline from diagnosis to the beginning of treatment(from January 2018 to December 2020)
- Patients' socioeconomic characteristics(from January 2018 to December 2020)
- Patients' demographics characteristics(from January 2018 to December 2020)
- BC pathological characterization(from January 2018 to December 2020)
- Timeline from diagnosis to molecular test(from January 2018 to December 2020)
- Rate of diagnostic tests to define breast cancer molecular subtypes performed(from January 2018 to December 2020)
研究者
研究点 (15)
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