Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer

NCT07404462 | Completed

• 1 other identifier: ERIDKE-0054/2023
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the correlation between immune-related factors in the tumor stroma and pathological complete response (pCR) in patients with early breast cancer treated with neoadjuvant chemotherapy. In addition, the study evaluates the association between immune-related tumor stroma factors and the presence of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in peripheral blood. The study includes serial blood sampling before and after treatment and during follow-up to assess the prognostic value of these biomarkers for disease progression and recurrence.

Conditions

Breast Cancer; Early Breast Cancer

Keywords

Neoadjuvant Chemotherapy; Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  Pathological complete response is defined as the absence of invasive carcinoma in the breast and axillary lymph nodes after neoadjuvant chemotherapy (ypT0/Tis ypN0).

  At surgery following completion of neoadjuvant chemotherapy

Study Arms (1)

Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy

Patients with early breast cancer receiving standard-of-care neoadjuvant chemotherapy according to institutional and international guidelines. Treatment is determined by the treating physician and is not assigned by the study protocol.

Other: Standard-of-Care Neoadjuvant Chemotherapy

Interventions

Standard-of-Care Neoadjuvant Chemotherapy OTHER

Standard neoadjuvant chemotherapy administered as part of routine clinical care. The regimen is determined by the treating physician and is not assigned by the study protocol.

Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy

Eligibility Criteria

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

Study Population

The study population includes adult patients with histologically confirmed early breast cancer treated at the Institute of Oncology Ljubljana who are candidates for standard-of-care neoadjuvant chemotherapy. Participants are enrolled prospectively and followed through surgery and subsequent follow-up to assess pathological complete response (pCR) and associations with tumor-infiltrating lymphocytes and circulating biomarkers.

You may qualify if:

• Female patients aged 18 years or older.
• Histologically confirmed early breast cancer.
• Candidates for standard neoadjuvant chemotherapy.
• Ability to provide informed consent.

You may not qualify if:

• Luminal A subtype of breast cancer.
• Prior systemic therapy for breast cancer.
• Serious comorbid conditions that would preclude study participation.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: March 1, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)