Gene profiling to determine chemotherapy needs in breast cancer patients
Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR+, HER- Breast Cancer Patients
This study is testing whether gene profiling can help decide if certain breast cancer patients need chemotherapy before surgery to improve their chances of survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jette, Brussel) |
| Trial ID | NCT05666258 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the necessity of neo-adjuvant chemotherapy in patients with HR+, HER2- breast cancer by utilizing Gene Expression Profiling (GEP). Patients diagnosed with specific tumor characteristics will undergo GEP testing to stratify them into low- or high-risk categories for cancer recurrence. Those identified as high-risk will receive neo-adjuvant chemotherapy prior to surgery, potentially improving their overall survival rates. The study focuses on surgical de-escalation, allowing for tailored treatment based on individual risk assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with newly diagnosed HR+, HER2- breast cancer and specific tumor characteristics.
Not a fit: Patients with advanced stage tumors (cT4, cN2-3, cM1) or those who have received chemotherapy in the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans, reducing unnecessary chemotherapy for low-risk patients while ensuring high-risk patients receive timely intervention.
How similar studies have performed: Other studies utilizing Gene Expression Profiling for treatment stratification in breast cancer have shown promising results, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tumour characteristics: HR+, HER- * Histopathological tumour characteristics: cT1-3, cN1, cM0, all histological types included * Age: 18-85 years Exclusion Criteria: * Tumour characteristics: cT4, cN2-3, cM1 * Age: \<18 or \>85 years old * Received chemotherapy in the last 5 years * Pregnancy
Where this trial is running
Jette, Brussel
- Universitair Ziekenhuis Brussel — Jette, Brussel, Belgium (Recruiting)
Study contacts
- Study coordinator: Ine Luyten, MD
- Email: borstkliniek@uzbrussel.be
- Phone: 02 477 6015
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.