About this trial
CTCs, CTC clusters, and ctDNA may predict treatment response and survival in high-risk breast cancer, including IBC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Liquid biopsy
Diagnostic testAdditional liquid biopsy to monitor disease
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Relapse-Free Survival (RFS)
RFS in patients who are - free of CTCs or CTC clusters at the end of neoadjuvant chemotherapy, comparing their outcomes with patients who still have CTCs or CTC clusters
Relapse-Free Survival (RFS)
RFS in patients who are - free of CTCs or CTC clusters after surgery, comparing them with those who still have CTCs or CTC clusters
Overall Survival (OS)
OS in patients who are - free of CTCs or CTC clusters at the end of neoadjuvant chemotherapy, comparing their outcomes with patients who still have CTCs or CTC clusters
Overall Survival (OS)
OS in patients who are - free of CTCs or CTC clusters after surgery, comparing them with those who still have CTCs or CTC clusters
Sponsors and contacts
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