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

Sponsor
Center Eugene Marquis
Study ID
NCT06358625
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pre-treatment biopsy — OTHER
    A breast biopsy is performed just before the "clip" is placed in the tumour and additional blood samples are performed.

Study Details

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.

Key Dates

First listed
Apr 10, 2024
Start date
Jun 6, 2024
Status verified
Jul 2025
Primary completion
Jun 6, 2031
Completion
Jun 6, 2031

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: HER positive
    The study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA.

Primary Outcome Measure

Transcriptomic profile change of HER2+ primary breast tumours before any treatment [ Time Frame: At inclusion ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials

Related Studies