🏛️ Verified NIH Record • Updated 2025-08-18

Comparison of the Breast Tumor Microenvironment (NCT03165487)

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

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Columbia University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (8 items).

Location: Columbia University Irving Medical Center — New York, New York

Age range: 50 Years

🧪 Interventions in This Study

  • Breast tissue collection (OTHER)
  • Blood sample collection (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Multifocal disease
  • Clinically N1 disease at diagnosis
  • Invasive lobular carcinoma
  • Metastatic disease
  • Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation)
  • Patients with known BRCA1/2 mutations
  • Pregnant or nursing

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Columbia University Irving Medical Center — New York, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗