Assessing PIK3CA mutations in metastatic breast cancer
PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach
European Institute of Oncology · NCT06706570
This study is testing a new way to find PIK3CA gene mutations in patients with metastatic breast cancer using both tissue samples and blood tests to see if it can help tailor treatments better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06706570 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of molecular methods to identify mutations in the PIK3CA gene in patients with metastatic breast cancer. It compares results from paraffin tissue sections and liquid biopsies, aiming to establish a less invasive diagnostic approach. By analyzing both types of samples, the study seeks to improve the accuracy of mutation detection, which could lead to more personalized treatment strategies for patients.
Who should consider this trial
Good fit: Ideal candidates are patients with ER+ and/or PgR+ HER2-negative metastatic breast cancer who have not yet received treatment.
Not a fit: Patients who have already undergone treatments such as chemotherapy or hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective treatment options for patients with metastatic breast cancer.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for mutation detection, indicating a growing interest in this less invasive approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory. * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * Patients must be accessible for follow-up. Exclusion Criteria: • patients already treated with different treatments like chemotherapy, hormone therapy etc
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: Breast Cancer Metastatic