PIK3CA Mutational Status Assessment
Recruiting · NCT06706570 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- European Institute of Oncology - Milan, MI, Italy