Studying the Role of Circulating Tumor Cell Clusters in Patients With High-risk Early Breast Cancer, Study GALIA

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitute of Oncology Ljubljana

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Liquid biopsy

    Diagnostic test

    Additional liquid biopsy to monitor disease

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: High risk breast cancer patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
before surgery
2

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.

Time frame
immediately after surgery
3

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.

Time frame
6 months after surgery
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.

Time frame
12 months after surgery

Secondary outcomes

1

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

Time frame
throughout study completion, an average of 2 years
2

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

Time frame
throughout study completion, an average of 2 years
3

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

Time frame
throughout study completion, an average of 3 years
4

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

Time frame
throughout study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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