NCT06706557

Brief Summary

A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
57mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2024Dec 2030

Study Start

First participant enrolled

January 11, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

November 22, 2024

Last Update Submit

March 23, 2026

Conditions

Advanced Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

    evaluate the mutations present in breast cancer of patients with advanced/metastatic disease e HER2-low defined with 1+ or 2+ expression levels by IHC (immunohistochemistry) technique and gene not amplified by ISH test (in situ hybridization)

    12 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

You may qualify if:

  • Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.
  • Participants should be at advanced or metastatic setting prior to treatment.
  • Patients must be accessible for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

00390294372079nicola.fusco@ieo.it

francesca lombardi, biologist

CONTACT

00390257489425francesca.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

January 11, 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)