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Clinical Trials in Italy / NCT06706570
Recruiting Observational

PIK3CA Mutational Status Assessment

NCT06706570 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Observational
Started
2024-11-06
Last updated
2026-03-24

Condition(s) studied

Breast Cancer Metastatic

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan MI Recruiting

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Other trials for the same condition

Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers Recruiting
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06706570 on ClinicalTrials.gov ↗ ← All trials in Italy