PIK3CA Mutational Status Assessment

Recruiting

• Conditions: Breast Cancer Metastatic

• Registration Number: NCT06706570
• Lead Sponsor: European Institute of Oncology

Brief Summary

Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.

Detailed Description

Evaluate the effectiveness and concordance of molecular methods in identifying mutations affecting the PIK3CA gene both on paraffin tissue sections of the tumor and on liquid biopsy of patients with breast cancer treated at the IEO. The molecular test on the liquid biopsy of same patient could bring an important benefit considering that the withdrawal of this biomaterial turns out to be less invasive than a biopsy performed on an organ

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-11-06
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.	2 years	Investigate concordance between sequencing panels again generation (NGS) based on different principles and different RT-PCR assays in detecting mutations of PIK3CA.

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, MI, Italy