Clinical trial · Observational
PIK3CA Mutational Status Assessment
PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach
NCT06706570CI-TRIAL-00106314recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.
- timeFrame
- 2 years
- description
- Investigate concordance between sequencing panels again generation (NGS) based on different principles and different RT-PCR assays in detecting mutations of PIK3CA.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.