NCT06706570

Recruiting

PIK3CA Mutational Status Assessment

European Institute of Oncology Source

Compare

Other study identifiers

Sponsor study identifier

IEO 2029

Study Type

observational

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

November 6, 2024

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 100 participants
Study completion date: December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 6, 2024
Actual (reported)
First Submitted
November 22, 2024
Actual (reported)
First Posted
November 26, 2024
Actual (reported)
Primary Completion
December 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: March 24, 2026
Status Verified: March 2026
Last Update Submitted: March 23, 2026

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

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

Sponsors & Collaborators

European Institute of Oncology
Otherlead

Study Sites (1)

European Institute of Oncology

Milan, MI, 20141, Italy

RECRUITING

Nicola Fusco, MDCONTACT00390294372079 nicola.fusco@ieo.it

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

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

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

NCT06784921

To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.

Recruiting

NCT06876636

Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer

Not ApplicableActive Not Recruiting

NCT06975462

A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases

Phase 2Not Yet Recruiting

NCT06750484

Trial of Trastuzumab Deruxtecan in Previously Treated HER2

Phase 2Recruiting

NCT06616987

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer

Phase 2Recruiting

NCT07137871

Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy

Phase 1Recruiting

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

Contact the study team to confirm eligibility.

francesca.lombardi@ieo.it

Study Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

March 24, 2026

Record last verified: 2026-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06706570
Data provider: ClinicalTrials.gov
Source updated: 2026-03-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:11 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations