Impact of HER2 Low on demographic profile and survival outcomes of Hormone positive breast cancer (HER- IMPACT).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- To evaluate the overall survival in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm.
研究概览
简要总结
Patients with histologically proven hormone-positive breast cancer who meet the eligibility criteria will be included in the study.
The following baseline parameters will be recorded: age, co-morbidities, ER, PR and HER-2 scores by IHC, HER-2 gene amplification by FISH result if HER-2 by IHC = 2+, tumour laterality, clinical tumour, nodal and metastatic staging (cTNM) as per American Joint Committee on Cancer (AJCC) eighth edition, whether operable breast cancer (OBC), locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
Further, details on neo-adjuvant chemotherapy, type of surgery, pathological grade of tumour, pathological tumour and nodal staging (pTNM), adjuvant chemotherapy, radiotherapy and hormonal therapy will be recorded. Follow-up details including the dates of progression, sites of metastases and the therapy received on progression shall also be recorded.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histologically confirmed invasive ductal carcinoma (IDC) breast, with the following specifications:.
- •Age: 15 years and above.
- •Diagnosed between 1st January 2015 and 31st December
- •Estrogen receptor (ER) or Progesterone receptor (PR) positive by IHC.
- •HER2 by IHC: Zero (0) or One plus (1+) or.
- •HER2 by IHC: Two plus (2+) and HER-2 gene amplification by FISH: non-amplified.
排除标准
- •1 Ductal carcinoma in-situ DCIS 2 Lobular carcinoma 3 Triple negative breast cancer ER, PR and HER2 negative by IHC 4 HER2 positive by IHC 5 HER2 by IHC: Two plus and HER2 gene amplification by FISH amplified equivocal uninterpretable or not done.
结局指标
主要结局
To evaluate the overall survival in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm.
时间窗: 5 years
次要结局
- To evaluate the DFS in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm in the curative setting.(2. To evaluate the PFS in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm in the metastatic setting.)
研究者
Dr Sudeep Gupta
Tata Memorial Center