ACTIVE_NOT_RECRUITING

Comparison of the Breast Tumor Microenvironment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-09-28
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03165487

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female, age greater than or equal to 40
  2. * 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
  3. * Human epidermal growth factor receptor 2 (HER2) negative regardless of hormone receptor status
  4. * Clinically less than or equal to 3cm unifocal lesion
  5. * Clinically node negative
  6. * Must have diagnostic mammogram performed within last 6 months
  7. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1
  8. * Appropriate renal, liver, and hematologic lab values
  9. * Ability to give informed consent
  1. * Multifocal disease
  2. * Clinically N1 disease at diagnosis
  3. * Invasive lobular carcinoma
  4. * Metastatic disease
  5. * Patients for whom RT would be contraindicated (e.g., connective tissue disorder or prior ipsilateral breast radiation)
  6. * Patients with known BRCA1/2 mutations
  7. * Pregnant or nursing

Contacts and Locations

Principal Investigator

Eileen Connolly, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor of Radiation Oncology

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Columbia University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-09-28
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2017-09-28
Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

  • Triple Negative Breast Cancer
  • microenvironment
  • IORT
  • Hormone Receptor Positive, HER 2 negative

Additional Relevant MeSH Terms

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