NCT07066917 Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer
| NCT ID | NCT07066917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hellenic Cooperative Oncology Group |
| Condition | Metastatic Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-10-15 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Diagnosis of early breast cancer at time of enrollment * Unwillingness to provide informed consent * Unwillingness to provide biological specimen * Lack of comprehensive clinical data
Contact & Investigator
Elena Fountzilas, MD, PhD
PRINCIPAL INVESTIGATOR
Hellenic Cooperative Oncology Group
Frequently Asked Questions
Who can join the NCT07066917 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07066917 currently recruiting?
Yes, NCT07066917 is actively recruiting participants. Contact the research team at e_sofou@hecog.ondsl.gr for enrollment information.
Where is the NCT07066917 trial being conducted?
This trial is being conducted at Athens, Greece, Athens, Greece, Athens, Greece, Athens, Greece and 1 additional location.
Who is sponsoring the NCT07066917 clinical trial?
NCT07066917 is sponsored by Hellenic Cooperative Oncology Group. The principal investigator is Elena Fountzilas, MD, PhD at Hellenic Cooperative Oncology Group. The trial plans to enroll 150 participants.
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