Comparison of the Breast Tumor Microenvironment

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Columbia University
Updated on 2 September 2021
breast cancer
growth factor
epidermal growth factor receptor
lobular carcinoma
triple negative breast cancer
epidermal growth factor
breast carcinoma
invasive breast cancer
breast-conserving surgery
core needle biopsy


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.


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.

Condition Breast Cancer, Metastatic Triple-Negative Breast Cancer, Triple Negative Breast Cancer, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Injection Port, Peripheral Arterial Occlusive Disease, Brain Function, Primary Immunodeficiency, Near-Sighted Corrective Surgery, Breast Cancer - HER2 Positive, Diet and Nutrition, Razor Bumps (Pseudofolliculitis Barbae), Vaginal Atrophy, Anal Dysplasia, Hormone Receptor Positive Malignant Neoplasm of Breast, Recurrent Respiratory Papillomatosis, Pediatric Health, Adverse Effects, Drugs
Treatment Blood sample collection, Breast tissue collection
Clinical Study IdentifierNCT03165487
SponsorColumbia University
Last Modified on2 September 2021


Yes No Not Sure

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
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