Analyzing tumor DNA in patients with low HER2 advanced breast cancer
A Pilot Study on the Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
European Institute of Oncology · NCT06706557
This study is testing if analyzing tumor DNA in patients with advanced breast cancer that has low HER2 levels can help track how the disease is progressing and how well treatments are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology (other) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06706557 on ClinicalTrials.gov |
What this trial studies
This pilot study focuses on the analysis of circulating tumor DNA (ctDNA) in patients diagnosed with advanced or metastatic breast cancer that exhibits low levels of HER2 expression. The study aims to assess the feasibility of ctDNA analysis in this specific patient population, defined by immunohistochemistry scores of 1+ or 2+ without gene amplification. A total of 30 patients will be enrolled, and their ctDNA will be monitored to gather insights into the disease's progression and treatment response. The study is conducted at a single center, the European Institute of Oncology in Milan.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with advanced or metastatic breast cancer characterized by low HER2 expression levels.
Not a fit: Patients with HER2-positive breast cancer or those not in an advanced or metastatic stage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of tumor dynamics in HER2-low breast cancer, potentially leading to better-targeted therapies.
How similar studies have performed: While studies on ctDNA in various cancers have shown promise, this specific focus on HER2-low advanced breast cancer is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion. * Patients must be accessible for follow-up.
Where this trial is running
Milan, MI
- European Institute of Oncology — Milan, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Nicola Fusco, MD — Istituto Europeo di Oncologia
- Study coordinator: Nicola Fusco, MD
- Email: nicola.fusco@ieo.it
- Phone: 00390294372079
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.
Conditions: Advanced Metastatic Breast Cancer