NCT03165487

Comparison of the Breast Tumor Microenvironment

Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.

Detailed description

There is evidence that the normal tissue around a tumor plays a role in determining how the tumor behaves, including how it will respond to treatments and how likely it is to recur. In breast cancer, radiation is used to decrease the chance of recurrence in the area where the tumor is removed. This risk of recurrence varies between different types of breast cancer. The investigators seek to study the proteins produced in normal tissue surrounding breast tumors. The tissue will be taken from women who are receiving radiation to the breast at the time of their surgery (known as intraoperative radiation), one specimen taken before radiation and one after. A new process will be used to stabilize the tissue rapidly and allow the proteins to be identified before they break down. This will allow us to identify differences in the proteins produced by cells before and after radiation and between two types of breast cancers, luminal A (less likely to recur) and triple negative (more likely to recur). Identifying these differences in proteins may allow them to be used in the future as markers to predict the likelihood of tumors recurring.

Conditions

• Triple Negative Breast Cancer
• Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

Type	Name	Description
OTHER	Breast tissue collection	During Breast Conservation Surgery, one sample will be collected before and after IORT.
OTHER	Blood sample collection	Blood will be collected before and after IORT, and at the two week follow-up.

Timeline

• Start date: 2017-09-28
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2017-05-24
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States