Analysis of molecular drivers in metastatic breast cancer
SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer
Lund University Hospital · NCT03758976
This study is trying to understand how metastatic breast cancer changes during treatment by looking at tissue and blood samples from patients to find clues that could help predict how well treatments will work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Hospital (other) |
| Locations | 2 sites (Lund and 1 other locations) |
| Trial ID | NCT03758976 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the molecular characteristics of metastatic breast cancer and how the disease evolves under treatment. It involves collecting biopsies and blood samples from patients to identify prognostic and predictive markers. The study will focus on understanding tumor evolution and developing biomarkers that indicate response or resistance to targeted therapies. By analyzing both tumor and normal tissue, researchers hope to gain insights into the mechanisms of resistance to treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with pathologically confirmed advanced breast cancer, including stage IV disease.
Not a fit: Patients with untreated psychiatric disorders that impair their ability to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with metastatic breast cancer.
How similar studies have performed: Other studies focusing on molecular profiling in metastatic breast cancer have shown promise, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease. 2. Age \> 18 years. 3. Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2. 4. ABC must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT-scan), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). 5. Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion. 6. Signed informed consent according to ICH/GCP, and national/local regulations. Exclusion Criteria: Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.
Where this trial is running
Lund and 1 other locations
- Lund University Hospital — Lund, Sweden (RECRUITING)
- Lund University Hospital — Lund, Sweden (RECRUITING)
Study contacts
- Study coordinator: Karolina Holm, PhD
- Email: karolina.holm@med.lu.se
- Phone: +46 730 84 17 61
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.
Conditions: Metastatic Breast Cancer, Metastatic breast cancer, Molecular profiling, Circulating tumor DNA, Circulating tumor cells