PIK3CA Mutational Status Assessment
ConditionBreast Cancer Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
A total of n=100 PIK3CA-mutant HR+/HER2- metastatic breast cancer patients will be prospectively collected. The mutational status of PIK3CA will be assessed on patients' FFPE metastasis sample tissues using a NGS panel, which covers the entire length of PIK3CA (full gene coverage). Patients with mutant PIK3CA status will be involved in the study and their FFPE as well as plasma samples will be profiled with all the different techniques (one remaining NGS panel and 2 RT-PCR assays).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.
Investigate concordance between sequencing panels again generation (NGS) based on different principles and different RT-PCR assays in detecting mutations of PIK3CA.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov