PIK3CA Mutational Status Assessment

NCT06706570 | Recruiting

• 1 other identifier: IEO 2029
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Metastatic

Outcome Measures

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.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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).

You may qualify if:

• 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.
• Patients must be accessible for follow-up.

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, MI, 20141, Italy

RECRUITING

Study Officials

• Nicola Fusco, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Fusco, MD

CONTACT

00390294372079; nicola.fusco@ieo.it

francesca lombardi, biologist

CONTACT

00390257489425; francesca.lombardi@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

IT (1)