NCT07418125

Brief Summary

CTCs, CTC clusters, and ctDNA may predict treatment response and survival in high-risk breast cancer, including IBC.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
32mo left

Started Feb 2024

Typical duration for not_applicable breast-cancer

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 Progress47%
Feb 2024Dec 2028

Study Start

First participant enrolled

February 7, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

February 3, 2026

Last Update Submit

February 10, 2026

Conditions

Breast Cancer

Keywords

breast cancerctDNAliquid biopsycirculating tumor cellcirculating tumor cluster

Outcome Measures

Primary Outcomes (4)

  • pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    before surgery

  • pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    immediately after surgery

  • pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    6 months after surgery

  • pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.

    12 months after surgery

Secondary Outcomes (4)

  • Relapse-Free Survival (RFS)

    throughout study completion, an average of 2 years

  • Relapse-Free Survival (RFS)

    throughout study completion, an average of 2 years

  • Overall Survival (OS)

    throughout study completion, an average of 3 years

  • Overall Survival (OS)

    throughout study completion, an average of 3 years

Study Arms (1)

High risk breast cancer patients

OTHER

Adult women with inflammatory breast cancer (stage IIID) and non-inflammatory triple negative and HER2+ subtype (stage IIB to IIIA-C) with adequate health status for neoadjuvant systemic treatment

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsyDIAGNOSTIC_TEST

Additional liquid biopsy to monitor disease

Also known as: ctDNA
High risk breast cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with inflammatory breast cancer, regardless of cancer subtype (stage IIID)
  • Patients with non-inflammatory breast cancer: triple-negative and HER2+ subtypes, from stage IIB to IIIA-C
  • Adequate health status for neoadjuvant systemic treatment

You may not qualify if:

  • Inflammatory breast cancer stage IV
  • Luminal A, luminal B subtypes of non-inflammatory breast cancer
  • Stages I-IIA breast cancer
  • Inability to understand or communicate in Slovenian
  • Inability to follow protocol instructions
  • Inappropriate health status for chemotherapy treatment
  • Primary treatment with surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplastic Cells, Circulating

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Central Study Contacts

Klavdija Korošec

CONTACT

00386 1 5879 639kkorosec@onko-i.si

Neza Gros

CONTACT

00386 1 5879 014ngros@onko-i.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 18, 2026

Study Start

February 7, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

SL(1)