跳至主要内容
临床试验/NCT06358625
NCT06358625招募中不适用

Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer

Center Eugene Marquis1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Transcriptomic profile change of HER2+ primary breast tumours before any treatment

研究概览

简要总结

HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.

At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).

The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.

International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.

To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.

New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Age ≥ 18 years old
  • be a female patient
  • Patients with histologically proven HER2-positive invasive breast cancer (IHC 3+ or 2+ with positive SISH),
  • Neoadjuvant chemotherapy and intra-tumour clips indicated at the multidisciplinary consultation meeting (RCP).
  • Signed Informed Consent Form

排除标准

  • pregnant or breast-feeding women
  • Have had a haematoma requiring level II analgesics at the time of the diagnostic biopsy.
  • Known coagulation disorders
  • Individual deprived of liberty or placed under the authority of a tutor, or a currator
  • Not be affiliated to a social security regimen

结局指标

主要结局

Transcriptomic profile change of HER2+ primary breast tumours before any treatment

时间窗: At inclusion

comparison of the transcriptomic profile of HER2+ primary breast tumours before any treatment of patients who will develop brain metastases within 5 years with patients who will not develop them

次要结局

  • Transcriptomic profile change on circulating tumour DNA (ctDNA)(At baseline, Year 1; Year2; Year3, Year4; Year 5, at relapse)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验