Why some new treatments work or stop working in advanced breast cancer
Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer
This project will see if biological markers explain why people with advanced breast cancer respond or become resistant to newer treatments like ADCs, immunotherapy, CDK inhibitors, and PARP inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hellenic Cooperative Oncology Group Academic / other |
| Locations | 5 sites (Athens and 4 other locations) |
| Trial ID | NCT07066917 on ClinicalTrials.gov |
What this trial studies
This is an observational program enrolling adults with locally advanced or metastatic breast cancer across hormone receptor–positive, HER2‑positive/-low, and triple‑negative subtypes. Participants who have received at least one treatment cycle will contribute clinical data and biological specimens for molecular and biomarker analyses. Researchers will correlate treatment type, clinical outcomes, and adverse events with molecular features to identify mechanisms of response and resistance. No experimental treatments are given as part of the protocol; care follows standard clinical practice at participating centers in Athens, Greece.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed locally advanced or metastatic breast cancer of any subtype who have received at least one treatment cycle and are willing to provide consent and biological specimens are ideal candidates.
Not a fit: Patients with early (non‑advanced) breast cancer, those unwilling to provide informed consent or biospecimens, or those lacking comprehensive clinical data will not be eligible and are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the work could help doctors choose and sequence treatments more effectively so patients receive therapies most likely to help them.
How similar studies have performed: Prior research has identified predictors for specific agents (for example, BRCA mutations for PARP inhibitors and PD‑L1 for some immune therapies), but comprehensive, integrated analyses across multiple new drug classes remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens and 4 other locations
- University General Hospital "ATTIKON", 2nd propedeutic dept. of Internal Medicine — Athens, Greece (Recruiting)
- "MITERA" Hospital, Dept. of Medical Oncology — Athens, Greece (Recruiting)
- Metropolitan Hospital, 2nd Dept. of Medical Oncology — Athens, Greece (Recruiting)
- Metropolitan Hospital, 4th Dept. of Medical Oncology — Athens, Greece (Recruiting)
- St. Luke's Hospital, Dept. of Medical Oncology — Thessaloniki, Greece (Recruiting)
Study contacts
- Principal investigator: Elena Fountzilas, MD, PhD — Hellenic Cooperative Oncology Group
- Study coordinator: Electra Sofou, PhD
- Email: e_sofou@hecog.ondsl.gr
- Phone: +302106912520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.