Comparison of the Breast Tumor Microenvironment
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 1/27/2019 |
| Start Date: | September 28, 2017 |
| End Date: | March 31, 2020 |
| Contact: | Eileen Connolly, MD |
| Email: | epc2116@cumc.columbia.edu |
| Phone: | 212-305-5050 |
Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment
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.
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.
There is evidence that the normal tissue around a tumor plays a role in determining how the
tumor behaves, including how it responds to treatments and how likely it is to recur.
tumor behaves, including how it responds to treatments and how likely it is to recur.
Inclusion Criteria:
- Female, age greater than or equal to 40
- Core biopsy proven invasive breast carcinoma or 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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-305-5050
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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