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临床试验/NCT01513408
NCT01513408进行中(未招募)不适用

Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy

Centre Georges Francois Leclerc1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Signed informed consent
  • •Social security coverage
  • •Age between 18 and 80 years
  • •Histologically proven breast cancer, regardless of histological type or molecular subtype (triple negative, hormone-receptor positive, HER2+++), including inflammatory forms
  • •Localised breast cancer with or without axillary or subclavicular lymph node involvement
  • •Absence of bone or visceral metastasis on further evaluation (bone scintigraphy, chest X-ray, abdominal echocardiography or CT scan of the thorax, abdomen and pelvic area)
  • •Treatment by neoadjuvant chemotherapy (treatment protocol at physician's discretion)
  • •Patient amenable to receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy, targeted therapy)
  • •Breast surgery (breast-sparing or not) planned after neoadjuvant chemotherapy

排除标准

  • •Metastatic breast cancer
  • •Neoadjuvant radiotherapy
  • •Patient not amenable to surgery
  • •Ongoing therapy for any other type of cancer
  • •Legal incapacity (incarceration or persons under legal guardianship)
  • •Patient unable to sign the informed consent or unable to attend medical follow-up for geographical, social or mental reasons.

研究组 & 干预措施

CD8/Foxp3

Experimental

patient suffering from non-metastatic breast cancer

干预措施: immunohistochemical detection of lymphocytes T CD8+/Foxp3 ratio (Other)

结局指标

主要结局

Overall survival

时间窗: From date of inclusion up to the end of follow-up period : december 2014 (anticipated)

Overall survival is defined as the time from inclusion date to death from any cause, or to date of last follow-up, if death does not occur.

次要结局

  • Recurrence-free survival(From inclusion up to the end of follow up period: december 2014)
  • Pathological complete response(After surgery)
  • PathIm score (pathological-immunological)(From inclusion up to the end of surgery for all patients: december 2014 (anticipated))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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