Assessing PIK3CA mutations in metastatic breast cancer
Official title: PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach
Run by European Institute of Oncology · NCT06706570 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | November 6, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2030 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT06706570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with ER+ and/or PgR+ HER2-negative metastatic breast cancer who have not yet received treatment.
✕Probably not a fit
Patients who have already undergone treatments such as chemotherapy or hormone therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using liquid biopsies for mutation detection, indicating a growing interest in this less invasive approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Decision Support Tool for People with Advanced Breast Cancer
This study tests a decision support tool called COAST to help people with stage IV breast cancer talk with their doctors and share treatment preferences.
-
HER2-PET to Predict T-DXd Benefit in Advanced Breast Cancer
This study tests whether HER2-PET imaging can help predict how well T-DXd will work for adults with advanced HER2-positive or HER2-low breast cancer receiving the drug.
-
Nutrition awareness for women after non-metastatic breast cancer
This online program tests whether an educational brochure and short surveys can help women who have finished treatment for non-metastatic breast cancer recognize unhealthy processed foods and be willing to change their diet.
-
Sapu003 with or without exemestane for advanced mTOR-sensitive solid tumors
This phase 1b test will try weekly IV Sapu003, given with exemestane for HR+/HER2- breast cancer or alone for other mTOR-sensitive advanced tumors, to see if it's safe and how your body handles it.
-
First-line Sacituzumab Govitecan for Advanced Untreated Triple-Negative Breast Cancer
This study tests whether Sacituzumab Govitecan can slow disease progression when given as a first treatment to adults with advanced triple-negative breast cancer who have not yet received treatment in the advanced setting.
-
OM-RCA-01 (anti-FGFR1 antibody) for metastatic tumors that express FGFR1
This trial will try OM-RCA-01, an IV antibody given every two weeks, in adults with metastatic cancers whose tumors test positive for FGFR1 and who have progressed after standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.