FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Dec 13, 2019

Keywords

ClinConnect Summary

The FATLAS clinical trial is studying how body fat affects breast cancer in patients. Researchers want to understand the differences in breast cancer based on patients' body types—specifically looking at those who are lean, overweight, or obese. They will collect information about participants' body measurements, take blood samples, and analyze tumor tissue to learn more about how fat and inflammation relate to different types of breast cancer.

To be eligible for the study, participants should have a specific type of breast cancer confirmed by a biopsy and be planning to have surgery to remove the tumor. The trial is open to both men and women aged between 18 and 80, and it includes different groups based on body weight. Participants will need to provide blood and tissue samples and undergo some measurements related to body fat. It's important to note that individuals who are pregnant or have a history of certain health conditions may not be eligible for this study. Overall, this trial aims to gather valuable information that could help improve treatment and understanding of breast cancer in relation to body fat.

Gender

ALL

Eligibility 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.