NCT01277926终止不适用
Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To assess the treatment choice by the medical oncologist for each patient.
研究概览
简要总结
The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Histological or cytological diagnosis of breast cancer
- •Postmenopausal status at the time of enrolment, according to the following definitions:
- •History of bilateral oophorectomy at any age
- •Proven hormonal menopause
- •Positive estrogen receptor (ER) and/or progesterone receptor (PR) by immuno
- •Failure of one previous endocrine therapy in the adjuvant or metastatic setting
- •Use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
- •Indication to receive chemotherapy or endocrine therapy
排除标准
- •Inability to comply with the study protocol
- •Use of more than one previous endocrine therapy, regardless of the setting; -- Previous use of chemotherapy for metastatic disease
- •Use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
- •Serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.
结局指标
主要结局
To assess the treatment choice by the medical oncologist for each patient.
时间窗: 12 months
次要结局
- To assess determinants of treatment choice(12 months)
- To evaluate the rate of treatment continuation at 6 months(12 months)
- To assess the duration of treatment with chemotherapy or endocrine therapy(12 months)
研究者
研究点 (1)
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