Characterizing fat tissue in breast cancer patients
FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.
This study is trying to understand how fat tissue affects breast cancer in patients by looking at different body measurements and analyzing blood and tissue samples.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04200768 on ClinicalTrials.gov |
What this trial studies
FATLAS is a prospective interventional study that aims to comprehensively characterize the micro- and macroenvironment of breast cancer based on patient adiposity across various histological and molecular subtypes. The study will assess adiposity using Body Mass Index (BMI), bioimpedance analysis, and waist-to-hip ratio, while also collecting blood samples for lipidomic and hormonal analyses. Additionally, it will involve microscopic profiling of adiposity and inflammation through histological characterization and advanced sequencing techniques on tumor and adjacent normal tissue samples.
Who should consider this trial
Good fit: Ideal candidates include lean, overweight, and obese patients with histologically confirmed invasive breast cancer, as well as male patients with any type of breast cancer.
Not a fit: Patients with metastatic breast cancer or those not scheduled for surgical resection of the tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of how adiposity influences breast cancer characteristics and treatment outcomes.
How similar studies have performed: While there have been studies examining the relationship between adiposity and breast cancer, this comprehensive multi-level characterization approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion of 30 lean (BMI 18.5 - 24.9 kg/m²), 30 overweight (BMI 25 - 29.9 kg/m²), and 30 obese (BMI ≥ 30 kg/m²) patients with histological confirmation of Invasive Ductal Carcinoma (IDC) on core diagnostic biopsy; 5 lean, 5 overweight and 5 obese Inflammatory Breast Cancer (IBC) patients; 15 lean, 15 overweight and 15 obese patients with histological confirmation of Invasive Lobular Carcinoma (ILC) on core diagnostic biopsy and 20 male subjects with any type of breast cancer that meet following criteria: * be willing and able to provide written informed consent for this study; * be willing to provide plasma/blood and tissue samples; * be willing to have clinical measures of adiposity taken; * have stage I, II or III disease (so non-metastatic) with any clinical lymph node status; * be scheduled for surgical resection of the tumour in UZ Leuven. * have a tumour size of ≥ 1.5 cm in order to have sufficient tumour material for the biomarker analysis. Exceptions will be made for IBC patients, as in some cases no residual tumour will be found after neoadjuvant treatment; * be treatment naïve, i.e. not having received systemic breast cancer treatment prior to surgery. An exception is made for the IBC patients, as they will often have received first line neoadjuvant chemotherapy before surgery. IBC patients that do not undergo surgery after neoadjuvant treatment (e.g. because of inoperability of the patient) will not be included; Exclusion Criteria: * pregnancy at time of diagnosis; * personal history of breast cancer (relapse/second primary); * mixed invasive tumour type on core biopsy or special type of breast carcinoma beside pure ILC; * history of an additional malignancy that is progressing or that has required active treatment in the 5 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer; * presence of an immune dysregulatory disease or condition which requires active immune modulatory treatment of any kind, or has required treatment in the past two years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; * history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial in the opinion of the treating investigator.
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Marion Maetens, PhD
- Email: marion.maetens@kuleuven.be
- Phone: +3216321194
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.