Comparison of tumor microenvironment in breast cancer patients
Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment
This study looks at how the normal tissue around breast tumors affects cancer behavior and treatment response in patients with luminal A and triple negative breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03165487 on ClinicalTrials.gov |
What this trial studies
This project aims to identify a molecular signature of tumor stroma from normal adjacent breast tissue collected during breast conserving surgery in patients with luminal A and triple negative breast cancer. The study will analyze tissue samples taken before and after intraoperative radiation therapy (IORT) to understand how the surrounding normal tissue influences tumor behavior and treatment response. By stabilizing the tissue rapidly, researchers will identify protein differences that may serve as markers for predicting tumor recurrence. This observational study focuses on the role of the microenvironment in breast cancer outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 and older with specific types of breast cancer who are undergoing breast conserving surgery and IORT.
Not a fit: Patients with multifocal disease, invasive lobular carcinoma, or those with contraindications to radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for predicting breast cancer recurrence based on molecular markers.
How similar studies have performed: Other studies have shown promise in understanding the tumor microenvironment, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, age greater than or equal to 40 * Core biopsy proven invasive breast carcinoma or ductal carcinoma in situ (DCIS), all subtypes excluding invasive lobular carcinoma due to increased risk for multifocal disease * Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status * Clinically less than or equal to 3cm unifocal lesion * Clinically node negative * Must have diagnostic mammogram performed within last 6 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 * Appropriate renal, liver, and hematologic lab values * Ability to give informed consent 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Eileen Connolly, MD — Assistant Professor of Radiation Oncology
- Study coordinator: Eileen Connolly, MD
- Email: epc2116@cumc.columbia.edu
- Phone: 212-305-5050
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.