Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Identifying risk factors for brain recurrence in HER2-positive breast cancer patients

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

Run by Center Eugene Marquis · NCT06358625 · Data updated 2026-11-12

This study is trying to find out what factors might lead to brain cancer returning in patients with HER2-positive breast cancer to help improve their treatment and care.

More HER2-positive Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment120 (estimated)
SponsorCenter Eugene Marquis
Academic / other
Drugs / interventionschemotherapy, trastuzumab, tucatinib
Locations1 site (Rennes)
StatusRecruiting
StartedJune 6, 2024
Main results expectedJune 6, 2031
Study endsJune 6, 2031
Registry record updatedAugust 1, 2025
Trial IDNCT06358625 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are female patients aged 18 and older with histologically confirmed HER2-positive invasive breast cancer.

Probably not a fit

Patients who are pregnant, breastfeeding, or have certain coagulation disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify risk factors associated with brain recurrence in patients diagnosed with HER2-positive localized breast cancer. It focuses on understanding the incidence of brain metastases in this patient population, particularly in relation to their treatment history and tumor characteristics. The study involves pre-treatment biopsies to gather necessary data for analysis. By examining these factors, the research seeks to improve prognostic assessments and treatment strategies for affected patients.

Why it matters

Potential benefit: If successful, this study could lead to better risk stratification and tailored treatment approaches for patients with HER2-positive breast cancer, potentially improving outcomes.

How similar studies have gone: Other studies have indicated the importance of identifying risk factors for brain metastases in breast cancer, suggesting that this approach has potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Centre de lutte contre le cancer Eugène Marquis
    Rennes, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.