Identifying risk factors for brain recurrence in HER2-positive breast cancer patients
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
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 |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Center Eugene Marquis Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab, tucatinib |
| Locations | 1 site (Rennes) |
| Trial ID | NCT06358625 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 18 and older with histologically confirmed HER2-positive invasive breast cancer.
Not a fit: Patients who are pregnant, breastfeeding, or have certain coagulation disorders may not benefit from this study.
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 performed: Other studies have indicated the importance of identifying risk factors for brain metastases in breast cancer, suggesting that this approach has potential for success.
Eligibility criteria
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 this trial is running
Rennes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.