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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre de lutte contre le cancer Eugène Marquis
RECRUITING
Rennes
Contact Information
Primary
Valérie JOLAINE, Dr
v.jolaine@rennes.unicancer.fr
(0)299253036
Backup
Marion TROCHET
m.trochet@rennes.unicancer.fr
(0)299253165
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2031-06-06
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Center Eugene Marquis

This content was sourced from clinicaltrials.gov