Genetic testing for triple-negative breast cancer patients
Evaluating the Feasibility of Next-Generation Sequencing - Based Germline and Somatic Genetic Testing in Triple-negative Breast Cancer. The PERSONA-breast Trial
This study is testing if genetic testing can help doctors make better treatment choices for patients with triple-negative breast cancer, especially those with BRCA mutations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT03920488 on ClinicalTrials.gov |
What this trial studies
This study focuses on implementing next-generation sequencing-based genetic testing for patients diagnosed with triple-negative breast cancer. It aims to assess the impact of genetic testing on risk management and therapeutic decisions, particularly for those with BRCA mutations. The study will utilize two genetic testing platforms to provide comprehensive characterization of both germline and somatic tissues, which may enhance clinical decision-making. The feasibility of integrating this testing into routine clinical workflows will also be evaluated.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with histologically confirmed triple-negative breast cancer who can undergo surgery.
Not a fit: Patients who are unable or unwilling to receive genetic counseling may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies and improved outcomes for patients with triple-negative breast cancer.
How similar studies have performed: Other studies have shown promise in using genetic testing for breast cancer, indicating that this approach may be beneficial, though the specific combination of methodologies in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age between 18 and 60 years 2. has signed informed consent 3. histologically confirmed triple negative breast cancer (ER (Estrogen Receptors) \< 1%, PgR (Progesterone Receptors) \< 1%, HER2/neu negative (IHC 0, 1+ or 2+ FISH negative). 4. Stage I-III 5. Able to undergo surgery (primary or post-neoadjuvant) 6. Availability of surgical/bioptic material within 6 months from enrolment Exclusion Criteria: * unable or unwilling to receive genetic counselling
Where this trial is running
Milan
- Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Viviana E Galimberti, MD — Ieo
- Study coordinator: Viviana E Galimberti, MD
- Email: viviana.galimberti@ieo.it
- Phone: +390257489717
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.