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Taking people in GreeceNo phase

Studying why breast cancer responds or stops responding to newer treatments

Studies how advanced breast cancer patients respond to newer drugs, using tumour and blood samples.

Plain-language title generated from the registry record
Registry title: Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer

Key facts

Where
Athens and Thessaloniki, GreeceSee the 5 sites

Where in Greece

  • "MITERA" Hospital, Dept. of Medical OncologyAthens, GreeceTaking people
  • Metropolitan Hospital, 2nd Dept. of Medical OncologyAthens, GreeceTaking people
  • Metropolitan Hospital, 4th Dept. of Medical OncologyAthens, GreeceTaking people
  • University General Hospital "ATTIKON", 2nd propedeutic dept. of Internal MedicineAthens, GreeceTaking people
  • St. Luke's Hospital, Dept. of Medical OncologyThessaloniki, GreeceTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
Hellenic Cooperative Oncology Group
Trial code
NCT07066917
Record updated
14 October 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

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

ClinicalTrials.gov NCT07066917