NCT07407244

Brief Summary

This prospective cohort study aims to identify immune-related predictive factors of response to neoadjuvant chemotherapy in patients with early breast cancer. The study will evaluate immune markers in tumor stroma and blood samples collected before treatment to determine their association with complete pathological remission (pCR). In addition, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) will be analyzed to explore their correlation with treatment response. The results may contribute to improved selection of patients who are most likely to benefit from neoadjuvant chemotherapy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 6, 2026

Last Update Submit

February 12, 2026

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response (pCR)

    To determine immune-related predictive factors of response to neoadjuvant chemotherapy in the tumor stroma of patients with early breast cancer, in relation to achieving pathological complete response (pCR).

    After completion of neoadjuvant chemotherapy (at surgery)

Study Arms (1)

Neoadjuvant Chemotherapy for Early Breast Cancer

OTHER

Patients with early breast cancer receiving standard neoadjuvant chemotherapy will be followed to assess immune-related tumor stroma factors and blood biomarkers in association with complete pathologic remission (pCR) and circulating tumor cells/circulating tumor DNA.

Drug: Neoadjuvant Chemotherapy

Interventions

Neoadjuvant ChemotherapyDRUG

Standard neoadjuvant chemotherapy administered to patients with early breast cancer according to institutional protocols. Treatment is not experimental and is part of routine clinical care. Immune-related tumor stroma factors and blood biomarkers will be analyzed in relation to pathological complete response (pCR) and circulating tumor cells/circulating tumor DNA.

Neoadjuvant Chemotherapy for Early Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with early breast cancer
  • Planned neoadjuvant chemotherapy (NACT)
  • Availability of tumor tissue sample (biopsy) before treatment
  • Ability to provide blood sample(s)
  • Signed informed consent

You may not qualify if:

  • Male breast cancer
  • Patients without neoadjuvant chemotherapy
  • Inability or refusal to provide informed consent
  • Insufficient biological material for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

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 6, 2026

First Posted

February 12, 2026

Study Start

March 1, 2017

Primary Completion

March 31, 2017

Study Completion

February 28, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)