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PIK3CA Mutational Status Assessment

RECRUITINGSponsored by European Institute of Oncology
Actively Recruiting
SponsorEuropean Institute of Oncology
Started2024-11-06
Est. completion2026-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06706570

Summary

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

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

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Conditions3

Breast CancerBreast Cancer, MetastaticCancer

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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