Recruiting
PIK3CA Mutational Status Assessment
Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.
ClinicalTrials.gov IDNCT06706570
PhaseNot Applicable
Enrollment100
SponsorEuropean Institute of Oncology
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer Metastatic
About this study
Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.
Primary outcomes
- Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach. (2 years)
Eligibility information
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
Study locations
- European Institute of Oncology, Milan, MI 20141 Italy
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.