BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 873
- 试验地点
- 1
- 主要终点
- BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
研究概览
简要总结
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.
详细描述
Background/Rationale: Within the setting of metastatic human epidermal growth factor receptor 2 negative (HER2-ve) breast cancer limited epidemiological data exist on the prevalence of pathogenic mutations of breast cancer susceptibility gene (BRCA) and other homologous recombination repair (HRR) genes. There are also limited data on the treatments and clinical outcomes of patients with such germline and somatic genetic profiles, particularly within this setting. This epidemiologic study will estimate the prevalence of germline breast susceptibility gene (gBRCA) mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy and, at that time, are considered to have exhausted hormone therapy options (if hormone receptor positive [HR+ve]), per investigator's opinion. Among those patients with a gBRCA gene mutation, treatment patterns and clinical outcomes will be described. This study may also explore the prevalence of somatic BRCA (sBRCA) mutations and other HRR gene mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy. The treatment patterns and clinical outcomes may be described among those patients with a sBRCA gene mutation and those with other HRR gene mutations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Provision of signed, written and dated informed consent.
- •Adult females (according to the age of majority/adulthood as defined by local regulations).
- •Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease.
- •Initiated treatment with 1st line systemic cytotoxic chemotherapy (not hormonal therapy) for metastatic breast cancer in the last 90 days and, at that time, are considered to have exhausted hormone therapy options (if HR+ve).
排除标准
- •Previous enrolment in this study.
- •Involvement in the planning and/or conduct of this study (applies to both AstraZeneca staff and/or staff at the study site).
- •Current participation in a clinical study with an investigational oncology product.
- •Previous PARPi therapy, including, but not limited to, participation in a previous clinical study that included PARPi therapy.
- •Current commencement of PARPi treatment.
结局指标
主要结局
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
时间窗: At one time point at inclusion in the study up to 12 months after the beginning of the study.
The prevalence of gBRCA gene mutations will be evaluated by calculating the proportion of patients that test positive for a gBRCA gene mutation (BRCA1 mutated and/or BRCA2 mutated).
次要结局
- Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.(2.5 years (30 months) since the beginning of the study.)
- Overall survival by line of therapy(2.5 years (30 months) since the beginning of the study.)
- Progression free survival by line of therapy(2.5 years (30 months) since the beginning of the study.)