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NCT Number: NCT06358625

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre de lutte contre le cancer Eugène Marquis

Rennes, 35 000, France

Location status: Recruiting

Location contact

Fanny LE DU, DR

PRINCIPAL_INVESTIGATOR

Fanny LE DU, Dr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-treatment biopsy

Other

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

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Transcriptomic profile change on circulating tumour DNA (ctDNA)

    Time frame: At baseline, Year 1; Year2; Year3, Year4; Year 5, at relapse

    High-throughput sequencing (NGS) of a panel of genes previously identified by transcriptomic analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Marion TROCHET

CONTACT

[email protected]

(0)299253165 ext. +33

Valérie JOLAINE, Dr

CONTACT

[email protected]

(0)299253036 ext. +33

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Acronym: CRANIUM

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Apr 10, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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