Comparison of the Breast Tumor Microenvironment

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Comparison of the Breast Tumor Microenvironment

Condition
Triple Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Eileen Connolly, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor of Radiation Oncology

Study Record Dates

2026-12-31