Real world data on clinicopathological characteristics and clinical outcomes of ERlow breast cancer from an Indian Multicenter registry and collaborative centers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1) To evaluate the the clinicopathological characteristics and clinical outcomes of ERlow breast cancer.
研究概览
简要总结
The updated American Society of Clinical Oncology/College of American Pathologists guideline for estrogen receptor (ER) testing recommended that breast cancer with ER expression in 1–10% of tumor cells should be reported as ER-low positive (ERlow). There is however limited data that is available on the benefits of endocrine therapy on them. The aim is to understand the clinicopathological characteristics and clinical outcomes of ERlow breast cancer breast cancers based on the data from the real world especially from a developing country like India.
Aims and objectives
1) To evaluate the the clinicopathological characteristics and clinical outcomes of ERlow breast cancer.
2) To determine the progression free survival (PFS) for patients with ERlow breast cancer.
3) To determine the overall survival (OS) for patients with ERlow breast cancer.
Methods
Retrospective multi center chart review done under the agesis of Network of oncology clinical trials in India and other collaborative centers. Data from electronic and paper bases of patients more than 18 years of age with ERlow breast cancer from these centres will be collected from January 1st 2018 to December 31st 2022. The data would be recorded and analysed statistically. Statistical analysis will be done using SPSS software version 22.
Key words
ER, PFS, OS, Real world
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient > 18 years of age 2) Patients with a histopathological proven diagnosis of breast cancer and with an IHC report of ER low positivity ( ER 1-10% ,PR 1-10%, Her 2 negative).
排除标准
- •< 18 years of age
- •Patients with breast cancer who are ER negative or High ER positive ( ER-0%, PR-0%, ER/PR>10%)
- •In case discrepancy between the ER status pre surgery and post surgery- the patients having high ER at any time will be excluded.
- •Her 2-3+ by IHC or FISH positive cases.
结局指标
主要结局
1) To evaluate the the clinicopathological characteristics and clinical outcomes of ERlow breast cancer.
时间窗: 1 YEAR, 2 YEARS, 3 YEARS , 4 YEARS , 5 YEARS
2) To determine the progression free survival (PFS) for patients with ERlow breast cancer.
时间窗: 1 YEAR, 2 YEARS, 3 YEARS , 4 YEARS , 5 YEARS
3) To determine the overall survival (OS) for patients with ERlow breast cancer.
时间窗: 1 YEAR, 2 YEARS, 3 YEARS , 4 YEARS , 5 YEARS
次要结局
- MODES OF TREATMENT(6months, 12 months, 18 months)
研究者
Ashwin Oommen Philips
Christian Medical College, Ludhiana