Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer

Recruiting now

Conditions studied: Metastatic Breast Cancer

In brief

Ample evidence has highlighted the significant clinical benefit of novel therapies for many patients with advanced breast cancer (aBC). The use of CDK inhibitors, antibody-drug conjugates (ADCs), immune checkpoint inhibitors (ICIs), and PARP inhibitors as first-line or subsequent treatments has improved progression-free survival (PFS) rates compared to conventional therapies. In selected cases, these treatments have also increased overall survival (OS), reshaping the therapeutic landscape for advanced breast cancer. However, several key questions remain unanswered. For example, what should be the first-line treatment when multiple effective options are available? Determining the optimal sequence of drugs in successive lines of therapy is another major challenge. Furthermore, the development of resistance to treatment and the occurrence of severe adverse events that may lead to early discontinuation or fatal outcomes are pressing concerns. That said, identifying robust predictive biomarkers of response or resistance is crucial for ensuring that patients receive the most effective treatment while avoiding unnecessary exposure to therapies that could cause harm without benefit. Additionally, when multiple effective options exist, selecting the optimal treatment algorithm for each patient based on clinical, pathological, and molecular biomarkers is essential. We herein, aim at employing high throughput methodologies, such as Whole Exome Sequencing, circulating tumour DNA (ctDNA) analysis, digital pathology and radiomics analyses, as well as real-world data obtained both from patients records for the training of a ML-based algorithm that can predict response or resistance to a specific treatment, based on the genetic make-up of the patient and the molecular profile of the tumour.

Key facts

Study ID: NCT07066917
Run by: Hellenic Cooperative Oncology Group
People needed: 150
Starts: 2024-10-15
Expected to finish: 2029-10-01
Last updated by the study team: 2025-07-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Eligible patients will be 18 years of age and older
Histologically confirmed, advanced breast cancer.
Diagnosis of i) hormone receptor positive and/or ii) HER2-positive or -low or iii) triple negative breast cancer (TNBC).
Patients will be included in the analysis after receiving at least one treatment cycle.

You may not qualify if…

Diagnosis of early breast cancer at time of enrollment
Unwillingness to provide informed consent
Unwillingness to provide biological specimen
Lack of comprehensive clinical data

Where it is running

University General Hospital "ATTIKON", 2nd propedeutic dept. of Internal Medicine — Athens, Greece (enrolling)
"MITERA" Hospital, Dept. of Medical Oncology — Athens, Greece (enrolling)
Metropolitan Hospital, 2nd Dept. of Medical Oncology — Athens, Greece (enrolling)
Metropolitan Hospital, 4th Dept. of Medical Oncology — Athens, Greece (enrolling)
St. Luke's Hospital, Dept. of Medical Oncology — Thessaloniki, Greece (enrolling)

Full record on ClinicalTrials.gov

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