RecruitingNCT06706570

PIK3CA Mutational Status Assessment

PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach


Sponsor

European Institute of Oncology

Enrollment

100 participants

Start Date

Nov 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • • 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 Criteria2

  • patients already treated with different treatments like chemotherapy, hormone therapy etc
  • \-

Locations(1)

European Institute of Oncology

Milan, MI, Italy

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NCT06706570


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