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

NCT ID: NCT06358625

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2031-06-06

Brief 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.

Conditions

HER2-positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pre-treatment biopsy

Intervention Type: OTHER

A breast biopsy is performed just before the "clip" is placed in the tumour and additional blood samples are performed.

Interventions

Pre-treatment biopsy

A breast biopsy is performed just before the "clip" is placed in the tumour and additional blood samples are performed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanny LE DU, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre de lutte contre le cancer Eugène Marquis

Locations

Centre de lutte contre le cancer Eugène Marquis

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Valérie JOLAINE, Dr

Role: CONTACT

v.jolaine@rennes.unicancer.fr

(0)299253036 ext. +33

Marion TROCHET

Role: CONTACT

m.trochet@rennes.unicancer.fr

(0)299253165 ext. +33

Facility Contacts

Fanny LE DU, Dr

Role: primary

Other Identifiers

2023-4-1-001

Identifier Type: -

Identifier Source: org_study_id