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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Center Eugene Marquis Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab, tucatinib |
| Locations | 1 site (Rennes) |
| Status | Recruiting |
| Started | June 6, 2024 |
| Main results expected | June 6, 2031 |
| Study ends | June 6, 2031 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT06358625 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
- Principal investigator: Fanny LE DU, Dr — Centre de lutte contre le cancer Eugène Marquis
- Study coordinator: Valérie JOLAINE, Dr
- Email: v.jolaine@rennes.unicancer.fr
- Phone: (0)299253036
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SMP-656 in HER2-positive advanced breast cancer after ADC therapy
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GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic breast cancer
This trial tests whether GQ1005 works as well as T-DM1 for adults with HER2-positive unresectable or metastatic breast cancer who have already had trastuzumab and taxane.
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Trastuzumab Rezetecan Neoadjuvant Therapy for HER2-Positive Breast Cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.