Evaluation of Degree of Conversion of HER2 Receptor Between Primary Breast Cancer and Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 32
- 主要终点
- Evaluation of degree of conversion of human epidermal growth factor receptor 2 (HER2) receptor between primary breast cancer and metastases
研究概览
简要总结
This is a Prospective Clinical Trial without drugs, to determine the HER2 status in the metastasis of patients with primary breast cancer HER2. 32 Sites have been taking part in this Clinical Trial.
详细描述
Population definition: Women previously diagnosed with a primary breast carcinoma who present locally recurrent or metastatic lesions and who meet the selection criteria. The expected sample size is 175 patients.
Observation period: Each patient in the study will be observed from their inclusion in the study until 1 year after the inclusion of the last patient in the study. These visits will match with the scheduled follow-up visits made by the patient according to the usual clinical practice of the site.
Determination of sample size: The calculation of the sample size will be based on determining a number of patients that will achieve the main objective of the study.
The fulfillment of the secondary objectives of the study will be obtained from the size determined by the main objective.
Main objective of the study is to: Prospectively determine the probability of conversion of the HER2 stage between the different subtypes of primary breast cancer (luminal, triple negative and HER2) and their respective metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients who have given their written informed consent to participate in the study.
- •Women over 18 years.
- •Breast cancer locally recurrent or metastatic at first relapse or after successive progressions.
- •Patient has to have available a sample of the primary tumor in paraffin.
- •Patients who are planning for the next 6 weeks, the biopsy (fine needle aspiration / drainage of fluid cavities, open biopsy, core biopsy) of locally recurrent or metastatic lesion [local relapse in the chest wall, nodal , cutaneous or subcutaneous metastases, peripheral lymph nodes and other soft tissues accessible, bone metastases, visceral metastases (lung, liver, brain, etc..) or pleural effusion / ascites / pericardial / cerebrospinal] according to clinical practice center.
排除标准
- •Patients with cognitive impairment that might impede a proper understanding of the written informed consent, according to medical criteria.
- •Ipsilateral breast local relapses or contralateral breast away.
- •Patients diagnosed with a second neoplasm, with the exception of cervical carcinoma in situ and non-melanoma skin carcinoma treated properly.
结局指标
主要结局
Evaluation of degree of conversion of human epidermal growth factor receptor 2 (HER2) receptor between primary breast cancer and metastases
时间窗: 2 years since the beginning of the Study
The conversion of HER2 is defined as the variation of the HER2 status between the primary tumor and the metastases, both from an initially negative to positive state and from an initially positive to negative state. The definition of the different molecular subtypes of primary breast cancer will be the following: * Luminal: immunohistochemical phenotype Estrogen Receptor (ER) positive and/or Progesterone Receptor (PR) positive, independently of HER2 status. * Triple negative: immunohistochemical phenotype ER negative, PR negative and HER2 negative. * HER2: immunohistochemical phenotype ER negative, PR negative and HER2 positive. For the calculation of this probability, a sample of the remnant of the primary tumor and the biopsy of the metastasis, performed according to the usual clinical practice of the site, will be sent to the central laboratory for analysis by immunohistochemistry (IHQ) and in situ hybridization (FISH) analysis.
次要结局
- Analyze the variability in the measurement of HER2, ER and PR between local laboratories and central laboratory(2 years since the beginning of the Study)
- Evaluate if the HER2 status conversion is associated with activation of intracellular markers of the HER2 signaling pathway: phosphorylated MAPK (pMAPK), phosphorylated ERK (pERK), phosphorylated AKT (pAKT), PTEN, PIGF-1R in primary tumor and metastases(2 years since the beginning of the Study)
- Compare the response rate (RR) and time to progression (TTP) for subsequent anti-tumor treatment of patients with or without conversion of HER2(2 years since the beginning of the Study)
- Analyze the extent to which discrepancies in the HER2 receptor status, ER and PR between the primary tumor and metastases alter the clinical management of patients.(2 years since the beginning of the Study)
- Evaluate whether the location of biopsied metastases relates to the probability of conversion of HER2.(2 years since the beginning of the Study)
- Analyze the feasibility of performing biopsies.(2 years since the beginning of the Study)
- To determine the probability of changes in ER and PR between different subtypes of primary breast cancer and their metastases(2 years since beginning of the Study)
- Evaluate HER2 conversion rate compared to previously received treatment(2 years since the beginning of the Study)
- Compare the disease-free survival (DFS) and survival post relapse (SPR) of patients with or without conversion of HER2 and ER/PR(2 years since the beginning of the Study)
- Check if there is any change in the molecular subtypes (luminal, triple negative, HER2) between primary tumors and metastases in patients with HER2 conversion(2 years since the beginning of the Study)